Product code PKB— Immunology
23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
- Classification name
- Autosomal Recessive Carrier Screening Gene Mutation Detection System
- Device class
- Class 2
- Regulation
- 21 CFR 866.5940
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code PKB
FDA has cleared device under product code PKB, all in 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code PKB
Recent clearances under product code PKB
Data sourced from openFDA. This site is unofficial and independent of the FDA.