# DEN140044: 23ANDME Personal Genome Service (Hereinafter Known as PGS)

- Pathway: De Novo (Direct)
- Applicant: 23AndMe
- Decided: Feb 19, 2015 after 266 days
- Product code: PKB (Autosomal Recessive Carrier Screening Gene Mutation Detection System)
- Device class: 2
- Regulation: 21 CFR 866.5940
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The 23andMe PGS Carrier Screening Test for Bloom Syndrome is indicated for the detection of the BLMAsh variant in the BLM gene from saliva collected using an FDA cleared collection device (Oragene DX model OGD-500.001). This test can be used to determine carrier status for Bloom syndrome, but cannot determine if a person has two copies of the BLMAsh variant. The test is most relevant for people of Ashkenazi Jewish descent.

Source page: https://510kreport.com/device/DEN140044
Methodology: https://510kreport.com/methodology