# P120019: Cobas Egfr Mutation Test

- Pathway: PMA
- Applicant: Roche
- Decided: May 14, 2013 after 187 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
- Jan 13, 2015 · Class III · Z-1320-2015: False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.

Source page: https://510kreport.com/device/P120019
Methodology: https://510kreport.com/methodology