# FDA Immunology device clearances: 95 since Nov 2024

Updated October 30, 2026.

FDA made 95 device decisions in immunology (FDA review panel) from December 17, 2024 to October 30, 2026: 44 510(k) clearances and De Novo grants and 51 PMA approvals and supplements, for 29 applicants. The newest, K262971 on October 30, 2026, is Xpert® Hemorrhagic Fever Panel from Cepheid.

## The full list

FDA immunology device clearances and approvals: 95 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 7 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-clearances/panel/immunology

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 95
- 510(k) and De Novo: 44
- PMA: 51
- Latest decision: October 30, 2026

## Newest decisions

The newest 95 of 95, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | K262971 | Xpert® Hemorrhagic Fever Panel | Cepheid | California | Substantially Equivalent | 510(k) traditional | QVR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262971) |
| October 23, 2026 | K260776 | VENTANA MMR IHC Panel | Roche Tissue Diagnostics, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | PZJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260776) |
| September 30, 2026 | K262893 | Eonis™ SMA kit | Revvity, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | QUE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262893) |
| September 22, 2026 | P930027/S041 | IMMULITE Systems PSA | Siemens Healthcare Diagnostics, Inc. |  | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930027S041) |
| September 22, 2026 | P060005/S027 | IMMULITE Systems Free PSA | Siemens Medical Solutions Diagnostics Limited |  | 30-day notice accepted | PMA 30-day notice | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060005S027) |
| September 22, 2026 | P010007/S028 | IMMULITE Systems AFP | Siemens Healthcare Diagnostics, Inc. | New York | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S028) |
| September 4, 2026 | K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | Siemens Healthcare Diagnostics Products, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | DHB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260331) |
| August 26, 2026 | P240021/S001 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA 180-day supplement | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240021S001) |
| August 21, 2026 | K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | Zeus Scientific | New Jersey | Substantially Equivalent | 510(k) traditional | MOB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261466) |
| August 21, 2026 | K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | LLL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253817) |
| August 20, 2026 | P930027/S040 | IMMULITE Systems PSA | Siemens Healthcare Diagnostics, Inc. |  | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930027S040) |
| August 20, 2026 | P060005/S026 | IMMULITE Systems Free PSA | Siemens Medical Solutions Diagnostics Limited |  | 30-day notice accepted | PMA 30-day notice | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060005S026) |
| August 20, 2026 | P010007/S027 | IMMULITE Systems AFP | Siemens Healthcare Diagnostics, Inc. | New York | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S027) |
| August 19, 2026 | K261686 | Elecsys Phospho-Tau (217P) Plasma | Roche Diagnostics | Indiana | Substantially Equivalent | 510(k) traditional | SET | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261686) |
| August 19, 2026 | K253240 | PrecivityAD2 Test | C2N Diagnostics, LLC | Missouri | Substantially Equivalent | 510(k) traditional | SET | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253240) |
| August 10, 2026 | K253528 | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. | New York | Substantially Equivalent | 510(k) traditional | NIG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253528) |
| August 7, 2026 | K261362 | Xpert Hemorrhagic Fever | Cepheid | California | Substantially Equivalent | De Novo (dual track) | QVR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261362) |
| July 28, 2026 | P200048/S001 | IsoPSA® Assay | Cleveland Diagnostics, Inc. | Ohio | Approved | PMA real-time process supplement | QRF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200048S001) |
| July 27, 2026 | P930027/S039 | IMMULITE 2000 PSA | Siemens Healthcare Diagnostics, Inc. |  | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930027S039) |
| July 27, 2026 | P060005/S025 | IMMULITE 2000 Free PSA | Siemens Medical Solutions Diagnostics Limited |  | 30-day notice accepted | PMA 30-day notice | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060005S025) |
| July 27, 2026 | P010007/S026 | IMMULITE 2000 AFP | Siemens Healthcare Diagnostics, Inc. | New York | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S026) |
| July 24, 2026 | K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut... | Hycor Biomedical | California | Substantially Equivalent | 510(k) traditional | DHB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261027) |
| July 21, 2026 | K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond... | Hycor Biomedical | California | Substantially Equivalent | 510(k) traditional | DHB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260591) |
| June 25, 2026 | K253367 | EliA CTD 13 Screen | Phadia AB | Sweden | Substantially Equivalent | 510(k) traditional | LLL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253367) |
| June 18, 2026 | K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab... | Hycor Biomedical | California | Substantially Equivalent | 510(k) traditional | DHB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260280) |
| June 16, 2026 | K253069 | Lipoprotein (a) Molarity Assay | Diazyme Laboratories, Inc. | California | Substantially Equivalent | 510(k) traditional | DFC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253069) |
| May 15, 2026 | K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036... | Hycor Biomedical | California | Substantially Equivalent | 510(k) traditional | DHB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260059) |
| May 11, 2026 | P930036/S026 | ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) | Siemens Healthcare Diagnostics, Inc. | Massachusetts | Approved | PMA real-time process supplement | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930036S026) |
| May 11, 2026 | P250026 | Atellica IM free PSA II (fPSAII) | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA original approval | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250026) |
| May 11, 2026 | P120008/S032 | ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120008S032) |
| May 8, 2026 | K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | Zeus Scientific | New Jersey | Substantially Equivalent | 510(k) traditional | OBE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250814) |
| April 29, 2026 | P990056/S046 | ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET | Roche Diagnostics Corp. | Indiana | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990056S046) |
| April 29, 2026 | P000027/S045 | ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK | Roche Diagnostics Corp. | Indiana | 30-day notice accepted | PMA 30-day notice | LTJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000027S045) |
| April 21, 2026 | P930027/S038 | IMMULITE 2000 PSA | Siemens Healthcare Diagnostics, Inc. |  | Approved | PMA 180-day supplement | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930027S038) |
| April 21, 2026 | P060005/S024 | IMMULITE 2000 Free PSA | Siemens Medical Solutions Diagnostics Limited |  | Approved | PMA 180-day supplement | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060005S024) |
| April 21, 2026 | P010007/S025 | IMMULITE 2000 AFP | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA 180-day supplement | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S025) |
| April 2, 2026 | K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | Indiana | Substantially Equivalent | 510(k) traditional | NQD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260026) |
| March 30, 2026 | K260812 | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | Georgia | Substantially Equivalent | 510(k) special | SGA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260812) |
| February 27, 2026 | P990056/S045 | Elecsys total PSA assay | Roche Diagnostics Corp. | Indiana | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990056S045) |
| February 27, 2026 | P000027/S044 | Elecsys free PSA assay | Roche Diagnostics Corp. | Indiana | 30-day notice accepted | PMA 30-day notice | LTJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000027S044) |
| February 23, 2026 | P910007/S068 | ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910007S068) |
| February 12, 2026 | P980007/S056 | ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980007S056) |
| February 12, 2026 | P910007/S067 | ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910007S067) |
| February 12, 2026 | P120008/S031 | ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120008S031) |
| February 6, 2026 | K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | California | Substantially Equivalent | 510(k) traditional | MSV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243979) |
| January 16, 2026 | K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4... | Hycor Biomedical | California | Substantially Equivalent | 510(k) traditional | DHB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252775) |
| January 5, 2026 | K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | New York | Substantially Equivalent | 510(k) traditional | LTJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251630) |
| December 23, 2025 | K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam... | Hycor Biomedical | California | Substantially Equivalent | 510(k) traditional | DHB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252493) |
| December 23, 2025 | DEN250032 | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) | DiaSorin, Inc. | Minnesota | Unknown | De Novo | SGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250032) |
| December 19, 2025 | K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Diazyme Laboratories, Inc. | California | Substantially Equivalent | 510(k) traditional | DFH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253358) |
| December 16, 2025 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | OVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250925) |
| December 4, 2025 | K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | New Jersey | Substantially Equivalent | 510(k) traditional | JNL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250816) |
| December 3, 2025 | P240021 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA original approval | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240021) |
| November 28, 2025 | P200048 | IsoPSA Assay | Cleveland Diagnostics, Inc. | Ohio | Approved | PMA original approval | QRF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200048) |
| November 3, 2025 | P980041/S051 | Access AFP (on DxI 9000 Analyzer) | Beckman Coulter, Inc. | California | Approved | PMA 180-day supplement | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980041S051) |
| October 30, 2025 | P930027/S037 | IMMULITE 2000 PSA | Siemens Healthcare Diagnostics, Inc. |  | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930027S037) |
| October 30, 2025 | P060005/S023 | IMMULITE 2000 Free PSA | Siemens Medical Solutions Diagnostics Limited |  | 30-day notice accepted | PMA 30-day notice | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060005S023) |
| October 30, 2025 | P010007/S024 | IMMULITE 2000 AFP | Siemens Healthcare Diagnostics, Inc. | New York | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S024) |
| October 22, 2025 | K250666 | Alegria Flash CTD Screen | Zeus Scientific | New Jersey | Substantially Equivalent | 510(k) traditional | LLL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250666) |
| October 17, 2025 | K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | New York | Substantially Equivalent | 510(k) traditional | JZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250250) |
| October 17, 2025 | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | SGG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250159) |
| October 8, 2025 | K252163 | Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics | Indiana | Substantially Equivalent | 510(k) traditional | SET | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252163) |
| September 30, 2025 | K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | Georgia | Substantially Equivalent | 510(k) traditional | SGA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252072) |
| September 19, 2025 | K250408 | Alegria Flash ENA Screen | Zeus Scientific | New Jersey | Substantially Equivalent | 510(k) traditional | LLL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250408) |
| August 14, 2025 | P930027/S036 | IMMULITE 2000 Prostate-Specific Antigen (PSA) | Siemens Healthcare Diagnostics, Inc. |  | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930027S036) |
| August 14, 2025 | P060005/S022 | IMMULITE 2000 Systems Free Prostate-Specific Antigen (Free PSA) | Siemens Medical Solutions Diagnostics Limited |  | 30-day notice accepted | PMA 30-day notice | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060005S022) |
| July 25, 2025 | P190022/S003 | 4Kscore Test | Opko Health, Inc. | Florida | Approved | PMA 180-day supplement | QRF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190022S003) |
| July 16, 2025 | P990055/S029 | ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) | Siemens Healthcare Diagnostics | Massachusetts | 30-day notice accepted | PMA 30-day notice | NAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990055S029) |
| July 16, 2025 | P950021/S030 | ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) | Siemens Healthcare Diagnostics | Massachusetts | 30-day notice accepted | PMA 30-day notice | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950021S030) |
| July 16, 2025 | P930036/S025 | ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) | Siemens Healthcare Diagnostics, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930036S025) |
| June 20, 2025 | K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | New York | Substantially Equivalent | 510(k) traditional | MSW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242981) |
| June 16, 2025 | P090026/S032 | Access Hybritech p2PSA | Beckman Coulter, Inc. | Minnesota | Approved | PMA 180-day supplement | OYA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090026S032) |
| June 12, 2025 | DEN240032 | APO-Easy Genotyping kit | Firalis SA | France | Unknown | De Novo | SFC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240032) |
| May 27, 2025 | P990056/S044 | ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET | Roche Diagnostics Corp. | Indiana | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990056S044) |
| May 27, 2025 | P000027/S043 | ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK | Roche Diagnostics Corp. | Indiana | 30-day notice accepted | PMA 30-day notice | LTJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000027S043) |
| May 23, 2025 | K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | DFH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250549) |
| May 22, 2025 | P020027/S042 | Dimension FPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | Delaware | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020027S042) |
| May 22, 2025 | P000021/S047 | Dimension TPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | Delaware | 30-day notice accepted | PMA 30-day notice | LTJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000021S047) |
| May 16, 2025 | K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | SET | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242706) |
| May 15, 2025 | P970038/S046 | Access Hybritech free PSA | Beckman Coulter, Inc. | California | Approved | PMA 180-day supplement | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970038S046) |
| May 7, 2025 | K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies... | Zeus Scientific | New Jersey | Substantially Equivalent | 510(k) traditional | MOB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243776) |
| April 23, 2025 | K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent... | Hycor Biomedical | California | Substantially Equivalent | 510(k) traditional | DHB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242531) |
| April 18, 2025 | K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | Washington | Substantially Equivalent | 510(k) traditional | DCK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242170) |
| April 11, 2025 | P010007/S023 | IMMULITE 2000 Alpha-Fetoprotein (AFP) | Siemens Healthcare Diagnostics, Inc. | New York | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S023) |
| April 3, 2025 | P980007/S055 | ARCHITECT Free PSA / Alinity i Free PSA | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980007S055) |
| April 3, 2025 | P910007/S066 | ARCHITECT Total PSA / Alinity i Total PSA | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910007S066) |
| April 3, 2025 | P120008/S030 | ARCHITECT AFP / Alinity i AFP | Abbott Laboratories | Illinois | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120008S030) |
| March 12, 2025 | K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit | Biofire Defense, LLC | Utah | Substantially Equivalent | 510(k) traditional | PRD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243822) |
| February 24, 2025 | P020027/S041 | Dimension FPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | Delaware | 30-day notice accepted | PMA 30-day notice | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020027S041) |
| February 24, 2025 | P000021/S046 | Dimension TPSA Flex reagent cartridge | Siemens Healthcare Diagnostics | Delaware | 30-day notice accepted | PMA 30-day notice | LTJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000021S046) |
| February 21, 2025 | P930027/S035 | IMMULITE® 2000 Prostate-Specific Antigen (PSA) | Siemens Healthcare Diagnostics, Inc. |  | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930027S035) |
| January 24, 2025 | K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations | Indiana | Substantially Equivalent | 510(k) traditional | DFC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241220) |
| January 15, 2025 | P930027/S034 | IMMULITE 2000 Prostate-Specific Antigen (PSA) | Siemens Healthcare Diagnostics, Inc. |  | 30-day notice accepted | PMA 30-day notice | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930027S034) |
| January 7, 2025 | K241456 | GlutenID Celiac Genetic Health Risk Test | Targeted Genomics, LLC | California | Substantially Equivalent | 510(k) traditional | PTA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241456) |
| December 17, 2024 | K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | California | Substantially Equivalent | 510(k) traditional | MID | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223093) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Siemens Healthcare Diagnostics, Inc. | 24 | September 22, 2026 |
| Abbott Laboratories | 8 | May 11, 2026 |
| Hycor Biomedical | 7 | July 24, 2026 |
| Siemens Medical Solutions Diagnostics Limited | 6 | September 22, 2026 |
| Roche Diagnostics Corp. | 6 | April 29, 2026 |
| Siemens Healthcare Diagnostics | 6 | July 16, 2025 |
| Zeus Scientific | 5 | August 21, 2026 |
| Roche Diagnostics | 3 | August 19, 2026 |
| Beckman Coulter, Inc. | 3 | November 3, 2025 |
| Cepheid | 2 | October 30, 2026 |
| Cleveland Diagnostics, Inc. | 2 | July 28, 2026 |
| Diazyme Laboratories, Inc. | 2 | June 16, 2026 |
| Centers for Disease Control and Prevention | 2 | March 30, 2026 |
| Inova Diagnostics, Inc. | 2 | February 6, 2026 |
| Fujirebio Diagnostics,Inc. | 2 | December 16, 2025 |
| The Binding Site Group , Ltd. | 2 | October 17, 2025 |
| Roche Tissue Diagnostics, Inc. | 1 | October 23, 2026 |
| Revvity, Inc. | 1 | September 30, 2026 |
| Siemens Healthcare Diagnostics Products, Ltd. | 1 | September 4, 2026 |
| Immunodiagnostics Systems Limited | 1 | August 21, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 40 | October 30, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 38 | September 22, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 8 | August 26, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 3 | May 11, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 2 | July 28, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 2 | December 23, 2025 |
| [De Novo (dual track)](https://specstream.ai/data/fda-clearances/decision/de-novo-dual-track) | 1 | August 7, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 1 | March 30, 2026 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 16 | October 30, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 13 | September 22, 2026 |
| [Indiana](https://specstream.ai/data/fda-clearances/state/indiana) | 10 | August 19, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 8 | May 11, 2026 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 6 | August 21, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 5 | September 30, 2026 |
| [United Kingdom](https://specstream.ai/data/fda-clearances/country/united-kingdom) | 4 | September 4, 2026 |
| [Delaware](https://specstream.ai/data/fda-clearances/state/delaware) | 4 | May 22, 2025 |
| [Ohio](https://specstream.ai/data/fda-clearances/state/ohio) | 2 | July 28, 2026 |
| [Georgia](https://specstream.ai/data/fda-clearances/state/georgia) | 2 | March 30, 2026 |
| [Minnesota](https://specstream.ai/data/fda-clearances/state/minnesota) | 2 | December 23, 2025 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 2 | December 16, 2025 |
| [Arizona](https://specstream.ai/data/fda-clearances/state/arizona) | 1 | October 23, 2026 |
| [Missouri](https://specstream.ai/data/fda-clearances/state/missouri) | 1 | August 19, 2026 |
| [Sweden](https://specstream.ai/data/fda-clearances/country/sweden) | 1 | June 25, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 1 | July 25, 2025 |
| [France](https://specstream.ai/data/fda-clearances/country/france) | 1 | June 12, 2025 |
| [Washington](https://specstream.ai/data/fda-clearances/state/washington) | 1 | April 18, 2025 |
| [Utah](https://specstream.ai/data/fda-clearances/state/utah) | 1 | March 12, 2025 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).