# FDA De Novo (dual track) decisions: 43 since Nov 2024

Updated October 27, 2026.

FDA made 43 device decisions of type De Novo (dual track) from November 19, 2024 to October 27, 2026: 43 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 27 applicants. The newest, K261379 on October 27, 2026, is BD Veritor System for SARS-CoV-2 from BD Diagnostic Solutions / Becton, Dickinson & Company.

## The full list

FDA De Novo (dual track) decisions: 43 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 1 row 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, decision type, date received 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/decision/de-novo-dual-track

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: 43
- 510(k) and De Novo: 43
- PMA: 0
- Latest decision: October 27, 2026

## Newest decisions

The newest 43 of 43, 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 27, 2026 | K261379 | BD Veritor System for SARS-CoV-2 | BD Diagnostic Solutions / Becton, Dickinson & Company | Maryland | Substantially Equivalent | De Novo (dual track) | QVF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261379) |
| October 21, 2026 | K262136 | BIOFIRE SPOTFIRE Vaginitis (VG) Panel | Biofire Diagnostics, LLC | Utah | Substantially Equivalent | De Novo (dual track) | PQA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262136) |
| October 21, 2026 | K261347 | DASH Flu A/B Test | Nuclein, LLC | Texas | Substantially Equivalent | De Novo (dual track) | OCC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261347) |
| September 4, 2026 | K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | California | Substantially Equivalent | De Novo (dual track) | QVF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254264) |
| September 4, 2026 | K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | California | Substantially Equivalent | De Novo (dual track) | PSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254262) |
| 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 10, 2026 | K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | ACON Laboratories, Inc. | California | Substantially Equivalent | De Novo (dual track) | SCA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261212) |
| June 15, 2026 | K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diasorin Molecular, LLC | California | Substantially Equivalent | De Novo (dual track) | PGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260333) |
| June 12, 2026 | K252932 | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | California | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252932) |
| June 12, 2026 | K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics | Indiana | Substantially Equivalent | De Novo (dual track) | PZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252323) |
| June 1, 2026 | K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. | Georgia | Substantially Equivalent | De Novo (dual track) | QVF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253882) |
| May 15, 2026 | K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | California | Substantially Equivalent | De Novo (dual track) | QEP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253759) |
| May 15, 2026 | K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | California | Substantially Equivalent | De Novo (dual track) | QEP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253756) |
| March 30, 2026 | K252269 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | North Carolina | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252269) |
| March 24, 2026 | K260787 | FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. | California | Substantially Equivalent | De Novo (dual track) | QXA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260787) |
| February 13, 2026 | K251742 | VELO Respiratory Test | Lex Diagnostics Limited | United Kingdom | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251742) |
| January 15, 2026 | K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | New Jersey | Substantially Equivalent | De Novo (dual track) | PSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252283) |
| January 9, 2026 | K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Massachusetts | Substantially Equivalent | De Novo (dual track) | CGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252206) |
| December 23, 2025 | K251978 | LIAISON NES FLU A/B, RSV & COVID-19 | Diasorin Molecular, LLC | California | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251978) |
| November 26, 2025 | K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | ACON Laboratories, Inc. | California | Substantially Equivalent | De Novo (dual track) | GTY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251697) |
| November 20, 2025 | K243753 | cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems, Inc. | California | Substantially Equivalent | De Novo (dual track) | OZZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243753) |
| November 14, 2025 | K251538 | Status™ COVID-19/Flu A&B | Princeton BioMeditech Corp. | New Jersey | Substantially Equivalent | De Novo (dual track) | SCA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251538) |
| October 22, 2025 | K251289 | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | China | Substantially Equivalent | De Novo (dual track) | QVF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251289) |
| October 1, 2025 | K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | California | Substantially Equivalent | De Novo (dual track) | QEP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251501) |
| August 14, 2025 | K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC | Utah | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243544) |
| June 17, 2025 | K243561 | Nano-Check Influenza+COVID-19 Dual Test | Nano-Ditech Corporation | New Jersey | Substantially Equivalent | De Novo (dual track) | SCA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243561) |
| June 16, 2025 | K243872 | BD Veritor System for SARS-CoV-2 | Becton, Dickinson and Company | Maryland | Substantially Equivalent | De Novo (dual track) | QVF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243872) |
| June 13, 2025 | K250273 | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | Maine | Substantially Equivalent | De Novo (dual track) | QVF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250273) |
| May 2, 2025 | K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | Israel | Substantially Equivalent | De Novo (dual track) | POV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243114) |
| April 25, 2025 | K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Roche Molecular Systems, Inc. | California | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243406) |
| April 25, 2025 | K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems, Inc. | California | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243400) |
| April 18, 2025 | K241188 | Acucy® Influenza A&B Test with the Acucy® 2 System | SEKISUI Diagnostics, LLC | California | Substantially Equivalent | De Novo (dual track) | PSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241188) |
| April 11, 2025 | K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | Roche Molecular Systems, Inc. | California | Substantially Equivalent | De Novo (dual track) | QWR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243346) |
| February 19, 2025 | K242526 | Visby Medical Respiratory Health Test | Visby Medical, Inc. | California | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242526) |
| February 3, 2025 | K240402 | Cito CBC System | Cytochip, Inc. | California | Substantially Equivalent | De Novo (dual track) | GKZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240402) |
| January 17, 2025 | K240217 | cobas® liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | California | Substantially Equivalent | De Novo (dual track) | QEP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240217) |
| January 16, 2025 | K240197 | cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | California | Substantially Equivalent | De Novo (dual track) | QEP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240197) |
| January 15, 2025 | K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Cepheid® | California | Substantially Equivalent | De Novo (dual track) | QQX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242109) |
| January 10, 2025 | K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | California | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242071) |
| December 20, 2024 | K241652 | DASH® SARS-CoV-2 & Flu A/B Test | Nuclein, LLC | Texas | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241652) |
| November 22, 2024 | K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Massachusetts | Substantially Equivalent | De Novo (dual track) | LCP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221326) |
| November 19, 2024 | K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Massachusetts | Substantially Equivalent | De Novo (dual track) | CGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221813) |
| November 19, 2024 | K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | Taidoc Technology Corporation | Taiwan | Substantially Equivalent | De Novo (dual track) | PZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221349) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Roche Molecular Systems, Inc. | 8 | May 15, 2026 |
| Nova Biomedical Corporation | 3 | January 9, 2026 |
| Biofire Diagnostics, LLC | 2 | October 21, 2026 |
| Nuclein, LLC | 2 | October 21, 2026 |
| Cepheid | 2 | August 7, 2026 |
| ACON Laboratories, Inc. | 2 | July 10, 2026 |
| Diasorin Molecular, LLC | 2 | June 15, 2026 |
| Nano-Ditech Corporation | 2 | January 15, 2026 |
| Visby Medical, Inc. | 2 | October 1, 2025 |
| BD Diagnostic Solutions / Becton, Dickinson & Company | 1 | October 27, 2026 |
| Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 1 | September 4, 2026 |
| Ortho Clinical Diagnostics Inc. (QuidelOrtho) | 1 | September 4, 2026 |
| Autonomous Medical Devices Incorporated | 1 | June 12, 2026 |
| Roche Diagnostics | 1 | June 12, 2026 |
| CorDx, Inc. | 1 | June 1, 2026 |
| Baebies, Inc. | 1 | March 30, 2026 |
| Lumos Diagnostics, Inc. | 1 | March 24, 2026 |
| Lex Diagnostics Limited | 1 | February 13, 2026 |
| Princeton BioMeditech Corp. | 1 | November 14, 2025 |
| Guangzhou Wondfo Biotech Co., Ltd. | 1 | October 22, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 35 | October 27, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 4 | June 12, 2026 |
| [Hematology](https://specstream.ai/data/fda-clearances/panel/hematology) | 3 | May 2, 2025 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 1 | August 7, 2026 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 23 | September 4, 2026 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 3 | January 15, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 3 | January 9, 2026 |
| [Maryland](https://specstream.ai/data/fda-clearances/state/maryland) | 2 | October 27, 2026 |
| [Utah](https://specstream.ai/data/fda-clearances/state/utah) | 2 | October 21, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 2 | October 21, 2026 |
| [Indiana](https://specstream.ai/data/fda-clearances/state/indiana) | 1 | June 12, 2026 |
| [Georgia](https://specstream.ai/data/fda-clearances/state/georgia) | 1 | June 1, 2026 |
| [North Carolina](https://specstream.ai/data/fda-clearances/state/north-carolina) | 1 | March 30, 2026 |
| [United Kingdom](https://specstream.ai/data/fda-clearances/country/united-kingdom) | 1 | February 13, 2026 |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 1 | October 22, 2025 |
| Maine | 1 | June 13, 2025 |
| [Israel](https://specstream.ai/data/fda-clearances/country/israel) | 1 | May 2, 2025 |
| [Taiwan](https://specstream.ai/data/fda-clearances/country/taiwan) | 1 | November 19, 2024 |

## 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/).