510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN160026Unknown

23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

23AndMe, Inc., Mountain View CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN160026 is the FDA 510(k) clearance record for 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia, a class II device, cleared for 23AndMe, Inc. on under FDA product code PTA (Genetic Variant Detection And Health Risk Assessment System). FDA's definition for product code PTA reads: "A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users...". FDA records list 9 510(k) clearances for 23AndMe, Inc., from to . As of , FDA records show no recalls naming DEN160026.

Clearance record

Decision date
Received
(282 days to decision)
Product code
PTA Genetic Variant Detection And Health Risk Assessment System
Regulation
21 CFR 866.5950
Device class
Class II
Review panel
Immunology
Applicant
23AndMe, Inc. 899 W. Evelyn Ave., Mountain View CA
Third party review
No

Clearances, product code PTA

Trailing 12 months

FDA records hold no clearances under product code PTA in the trailing twelve months.

FDA records show no clearances under product code PTA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PTA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260