PKB — Autosomal Recessive Carrier Screening Gene Mutation Detection System Class II
FDA product code PKB covers "Autosomal Recessive Carrier Screening Gene Mutation Detection System", a Class II medical device regulated under 21 CFR 866.5940. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PKB
- Device Class
- Class II
- Regulation Number
- 866.5940
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
Definition
Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or saliva specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN140044 | 23andme | 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) | February 19, 2015 |