# P150047: cobas EGFR MUTATION TEST v2

- Pathway: PMA
- Applicant: Roche Molecular Systems, Inc.
- Decided: Jun 1, 2016 after 175 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
- Sep 3, 2021 · Class II · Z-0083-2022: False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment

Source page: https://510kreport.com/device/P150047
Methodology: https://510kreport.com/methodology