therascreen FGFR RGQ RT-PCR Kit

FDA Premarket Approval P180043 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for incorporation of a lower boundary for the therascreen fgfr rgq rt-pcr assay ct cutoff and an update to the software and handbook to address this change

• Device: therascreen FGFR RGQ RT-PCR Kit
• Generic Name: Somatic Gene Mutation Detection System
• Applicant: QIAGEN GmbH
• Date Received: 2021-09-20
• Decision Date: 2021-11-16
• PMA: P180043
• Supplement: S003
• Product Code: OWD
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: QIAGEN GmbH qiagen Strasse 1 hilden

Supplemental Filings

Supplement Number	Date	Supplement Type
P180043		Original Filing
S003	2021-09-20	Real-time Process
S002	2020-03-04	30-day Notice
S001

NIH GUDID Devices

Device ID	PMA	Supp
04053228034094	P180043	000
04053228043560	P180043	001