# FDA Medical Genetics device clearances: 41 since Nov 2024

Updated October 27, 2026.

FDA made 41 device decisions in medical genetics (FDA review panel) from December 6, 2024 to October 27, 2026: 1 510(k) clearances and De Novo grants and 40 PMA approvals and supplements, for 10 applicants. The newest, P250029/S003 on October 27, 2026, is SimpleScreen™ CRC from Freenome, LLC.

## The full list

FDA medical genetics device clearances and approvals: 41 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 3 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/medical-genetics

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: 41
- 510(k) and De Novo: 1
- PMA: 40
- Latest decision: October 27, 2026

## Newest decisions

The newest 41 of 41, 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 | P250029/S003 | SimpleScreen™ CRC | Freenome, LLC | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250029S003) |
| October 16, 2026 | P240010/S007 | MI Cancer Seek | Caris Life Sciences | Arizona | Approved | PMA real-time process supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240010S007) |
| October 5, 2026 | P230009/S021 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S021) |
| September 16, 2026 | P230009/S020 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S020) |
| September 15, 2026 | P250046 | OncoMate® MSI Dx Analysis System | Promega Corporation | Wisconsin | Approved | PMA original approval | SFL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250046) |
| August 26, 2026 | P250029/S001 | SimpleScreen™ CRC | Freenome, LLC | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250029S001) |
| July 30, 2026 | P250036 | PGDx elio tissue complete CDx | Personal Genome Diagnostics, Inc. | Maryland | Approved | PMA original approval | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250036) |
| July 24, 2026 | P250029 | SimpleScreen™ CRC | Freenome, LLC | California | Approved | PMA original approval | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250029) |
| July 22, 2026 | P230009/S010 | Shield | Guardant Health, Inc. | California | Approved | PMA 180-day supplement | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S010) |
| July 21, 2026 | P230009/S018 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S018) |
| July 2, 2026 | P240010/S010 | MI Cancer Seek | Caris Life Sciences | Arizona | 30-day notice accepted | PMA 30-day notice | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240010S010) |
| July 2, 2026 | K252243 | Fastplex™ BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | China | Substantially Equivalent | 510(k) traditional | OYX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252243) |
| May 28, 2026 | P240010/S009 | MI Cancer Seek® | Caris Life Sciences | Arizona | 30-day notice accepted | PMA 30-day notice | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240010S009) |
| May 28, 2026 | P170041/S009 | Abbott RealTime IDH1 | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170041S009) |
| May 28, 2026 | P170005/S006 | Abbott RealTime IDH2 | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170005S006) |
| May 21, 2026 | P230009/S016 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S016) |
| May 6, 2026 | P180043/S010 | QIAGEN therascreen® FGFR RGQ RT-PCR Kit | QIAGEN GmbH |  | Approved | PMA real-time process supplement | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180043S010) |
| April 15, 2026 | P230009/S014 | Shield | Guardant Health, Inc. | California | Approved | PMA real-time process supplement | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S014) |
| April 1, 2026 | P230009/S015 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S015) |
| March 20, 2026 | P170041/S008 | Abbott RealTime IDH1 | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170041S008) |
| March 20, 2026 | P170005/S005 | Abbott RealTime IDH2 | Abbott Molecular, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170005S005) |
| February 4, 2026 | P230009/S013 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S013) |
| December 22, 2025 | P230009/S011 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S011) |
| November 5, 2025 | P240026 | OncoMate® MSI Dx Analysis System | Promega Corporation | Wisconsin | Approved | PMA original approval | SFL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240026) |
| October 30, 2025 | P230009/S009 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S009) |
| October 22, 2025 | P190001/S002 | therascreen® PIK3CA RGQ PCR Kit | QIAGEN GmbH |  | Approved | PMA 180-day supplement | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190001S002) |
| October 3, 2025 | P180043/S007 | QIAGEN therascreen® FGFR RGQ RT-PCR Kit | QIAGEN GmbH |  | Approved | PMA 180-day supplement | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180043S007) |
| September 23, 2025 | P230009/S008 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S008) |
| August 15, 2025 | P250005 | Idylla CDx MSI Test | Biocartis Us, Inc. | Illinois | Approved | PMA original approval | SFL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250005) |
| July 23, 2025 | P230009/S007 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S007) |
| June 20, 2025 | P220006/S007 | VENTANA FOLR1 (FOLR-2.1) RxDx Assay | Ventana Medical Systems, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | QUL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220006S007) |
| June 18, 2025 | P240010/S005 | MI Cancer Seek | Caris Life Sciences | Arizona | 30-day notice accepted | PMA 30-day notice | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240010S005) |
| June 9, 2025 | P240010/S004 | MI Cancer Seek | Caris Life Sciences | Arizona | 30-day notice accepted | PMA 30-day notice | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240010S004) |
| June 4, 2025 | P240010/S003 | MI Cancer Seek | Caris Life Sciences | Arizona | Approved | PMA real-time process supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240010S003) |
| April 28, 2025 | P230009/S006 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S006) |
| March 12, 2025 | P230009/S005 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S005) |
| February 6, 2025 | P240010/S001 | MI Cancer Seek | Caris Life Sciences | Arizona | Approved | PMA real-time process supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240010S001) |
| January 8, 2025 | P220006/S006 | VENTANA FOLR1 (FOLR1-2.1) RxDx Assay | Ventana Medical Systems, Inc. | Arizona | Approved | PMA real-time process supplement | QUL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220006S006) |
| January 7, 2025 | P240010/S002 | MI Cancer Seek | Caris Life Sciences | Arizona | 30-day notice accepted | PMA 30-day notice | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240010S002) |
| January 2, 2025 | P230009/S004 | Shield | Guardant Health, Inc. | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009S004) |
| December 6, 2024 | P180043/S008 | therascreen FGFR RGQ PCR Kit | QIAGEN GmbH |  | Approved | PMA 180-day supplement | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180043S008) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Guardant Health, Inc. | 15 | October 5, 2026 |
| Caris Life Sciences | 8 | October 16, 2026 |
| Abbott Molecular, Inc. | 4 | May 28, 2026 |
| QIAGEN GmbH | 4 | May 6, 2026 |
| Freenome, LLC | 3 | October 27, 2026 |
| Promega Corporation | 2 | September 15, 2026 |
| Ventana Medical Systems, Inc. | 2 | June 20, 2025 |
| Personal Genome Diagnostics, Inc. | 1 | July 30, 2026 |
| Suzhou Precigenome, Ltd. Co; | 1 | July 2, 2026 |
| Biocartis Us, Inc. | 1 | August 15, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 25 | October 27, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 6 | October 16, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 5 | September 15, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 4 | July 22, 2026 |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 1 | July 2, 2026 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 18 | October 27, 2026 |
| [Arizona](https://specstream.ai/data/fda-clearances/state/arizona) | 10 | October 16, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 5 | May 28, 2026 |
| [Wisconsin](https://specstream.ai/data/fda-clearances/state/wisconsin) | 2 | September 15, 2026 |
| [Maryland](https://specstream.ai/data/fda-clearances/state/maryland) | 1 | July 30, 2026 |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 1 | July 2, 2026 |

## 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/).