PMA P110027S003

Device: THERASCREEN KRAS RGQ PCR KIT
Applicant: QIAGEN GmbH
PMA number: P110027
Supplement: S003
Product code: OWD
Decision date: 2015-01-16
Classification: Somatic Gene Mutation Detection System
Generic name: Somatic gene mutation detection system
Approval order statement: CHANGE TO THE SUPPLIERS PURITY TESTING METHOD FOR THE INTERNAL CONTROL TEMPLATE IN YOUR THERASCREEN KRAS RGQ PCR KIT. THE NEW PURITY TESTING WILL USE REVERSED PHASE-ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY (RP-UPLC) WITH A CHANGE IN ACCEPTANCE CRITERION FROM >=90% TO >=80%.

Current openFDA PMA Record#

Device: THERASCREEN KRAS RGQ PCR KIT
Applicant: QIAGEN GmbH
PMA number: P110027
Supplement: S003
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2015-01-16
Decision code: OK30
Date received: 2014-12-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE SUPPLIERS PURITY TESTING METHOD FOR THE INTERNAL CONTROL TEMPLATE IN YOUR THERASCREEN KRAS RGQ PCR KIT. THE NEW PURITY TESTING WILL USE REVERSED PHASE-ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY (RP-UPLC) WITH A CHANGE IN ACCEPTANCE CRITERION FROM >=90% TO >=80%.