PMA P120022S002

Device: THERASCREEN EGFR RGQ PCR KIT
Applicant: QIAGEN GmbH
PMA number: P120022
Supplement: S002
Product code: OWD
Decision date: 2014-12-19
Classification: Somatic Gene Mutation Detection System
Generic name: Somatic gene mutation detection system
Approval order statement: CHANGE TO THE MANUFACTURING METHOD OF THE POSITIVE CONTROL (PC) IN THE EGFR RGQ PCR KIT. THE CHANGE IN MANUFACTURING METHOD INCLUDES AN ADJUSTMENT STEP OF AN IN-PROCESS PROCEDURE TO ENSURE THAT TARGETED AMOUNTS OF EACH OLIGONUCLEOTIDE WITHIN THE PC ARE CALCULATED TO ACHIEVE THE TARGET CROSSING THRESHOLD (CT).

Current openFDA PMA Record#

Device: THERASCREEN EGFR RGQ PCR KIT
Applicant: QIAGEN GmbH
PMA number: P120022
Supplement: S002
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2014-12-19
Decision code: OK30
Date received: 2014-11-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE MANUFACTURING METHOD OF THE POSITIVE CONTROL (PC) IN THE EGFR RGQ PCR KIT. THE CHANGE IN MANUFACTURING METHOD INCLUDES AN ADJUSTMENT STEP OF AN IN-PROCESS PROCEDURE TO ENSURE THAT TARGETED AMOUNTS OF EACH OLIGONUCLEOTIDE WITHIN THE PC ARE CALCULATED TO ACHIEVE THE TARGET CROSSING THRESHOLD (CT).