# P110027: Therascreen Kras RGQ PCR Kit

- Pathway: PMA
- Applicant: QIAGEN GmbH
- Decided: May 23, 2014 after 1,033 days
- Product code: OWD (Somatic Gene Mutation Detection System)
- Device class: 3
- Recalls of this device: 2 (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
- Feb 25, 2022 · Class II · Z-0952-2022: False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit
- Feb 25, 2022 · Class II · Z-0951-2022: False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit

Source page: https://510kreport.com/device/P110027
Methodology: https://510kreport.com/methodology