Review Panel
Medical Genetics FDA 510(k) Clearances & Devices
- Cleared Devices
- 17
- Product Codes (page)
- 6
- Latest Decision
- 2026-07-02
Clearances
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K252243 | Fastplex BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | OYX | Class II | 2026-07-02 |
| K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | Suzhou Sniper Medical Technologies Co., Ltd. | OYX | Class II | 2023-09-05 |
| K223597 | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | 23AndMe, Inc. | QAZ | Class II | 2023-08-31 |
| K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23AndMe, Inc. | QDJ | Class II | 2022-10-26 |
| K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | 23AndMe, Inc. | QAZ | Class II | 2022-01-06 |
| DEN190035 | Helix Laboratory Platform | Helix Opco, LLC | QNC | Class II | 2020-12-23 |
| K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23AndMe, Inc. | QDJ | Class II | 2020-08-17 |
| K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems | Cepheid | OYX | Class II | 2019-09-27 |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. | OYX | Class II | 2019-02-13 |
| K182784 | MUTYH-Associated Polyposis (MAP) | 23AndMe, Inc. | QAZ | Class II | 2019-01-18 |
| DEN170070 | MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit | Cytocell, Ltd. | QDI | Class II | 2018-12-21 |
| DEN180028 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23AndMe, Inc. | QDJ | Class II | 2018-10-31 |
| DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | 23AndMe, Inc. | QAZ | Class II | 2018-03-06 |
| K172287 | ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. | PSU | Class II | 2018-01-12 |
| K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | Molecularmd Corporation | OYX | Class II | 2017-12-22 |
| DEN160028 | ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. | PSU | Class II | 2017-03-27 |
| DEN160003 | Quantidex qPCR BCR-ABL IS Kit | Asuragen, Inc. | OYX | Class II | 2016-07-22 |
17 clearances in the Medical Genetics panel. Data: openFDA.