FDA product code PKB: Autosomal Recessive Carrier Screening Gene Mutation Detection System

PKB is the FDA product code for autosomal recessive carrier screening gene mutation detection system. It is a Class II device, regulated under 21 CFR 866.5940 and reviewed by the Pathology panel. Devices under PKB reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for PKB devices

openFDA lists no recalls for product code PKB.

Frequently asked questions

What is FDA product code PKB?

PKB is the FDA product code for autosomal recessive carrier screening gene mutation detection system. It is a Class II device, regulated under 21 CFR 866.5940 and reviewed by the Pathology panel.

What device class is PKB?

Class II, regulation 21 CFR 866.5940. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code PKB
• Run a recall and safety report across every PKB manufacturer
• Watch product code PKB for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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