510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PKBClass II

Autosomal Recessive Carrier Screening Gene Mutation Detection System

21 CFR 866.5940 / Immunology
FDA source (opens on fda.gov)

PKB is the FDA product code for Autosomal Recessive Carrier Screening Gene Mutation Detection System, a class II device type, regulated under 21 CFR 866.5940. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PKB
Device name
Autosomal Recessive Carrier Screening Gene Mutation Detection System
FDA 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.
Regulation
21 CFR 866.5940
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PKB

By decision year
1 clearance under product code PKB with a decision year between 2015 and 2015, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PKB by decision year
YearClearances
20151

Applicants with the most clearances

Product code PKB
Applicants holding the most 510(k) clearances under product code PKB
ApplicantClearances
23AndMe, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code