# P110020: Cobas 4800 Braf V600 Mutation Test

- Pathway: PMA
- Applicant: Roche Molecular Systems, Inc.
- Decided: Aug 17, 2011 after 114 days
- Product code: OWD (Somatic Gene Mutation Detection System)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 31, 2012 · Class III · Z-0188-2013: It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two con

Source page: https://510kreport.com/device/P110020
Methodology: https://510kreport.com/methodology