# P190004: therascreen PIK3CA RGQ PCR Kit

- Pathway: PMA
- Applicant: QIAGEN GmbH
- Decided: May 24, 2019 after 98 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
- Dec 11, 2020 · Class II · Z-0937-2021: Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.

Source page: https://510kreport.com/device/P190004
Methodology: https://510kreport.com/methodology