# P120022: Therascreen Egfr RGQ PCR Kit

- Pathway: PMA
- Applicant: QIAGEN GmbH
- Decided: Jul 12, 2013 after 224 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
- Apr 8, 2020 · Class II · Z-2290-2020: There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutati

Source page: https://510kreport.com/device/P120022
Methodology: https://510kreport.com/methodology