|
Device | THERASCREEN EGFR RGQ PCR KIT |
Generic Name | Somatic gene mutation detection system |
Applicant | QIAGEN GmbH QIAGEN Strasse 1 Hilden 40724 |
PMA Number | P120022 |
Supplement Number | S002 |
Date Received | 11/19/2014 |
Decision Date | 12/19/2014 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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). |