THERASCREEN EGFR RGQ PCR KIT

FDA premarket approval P120022/S002 · decided 2014-12-19

Approval details

PMA number

P120022

Supplement

S002

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

THERASCREEN EGFR RGQ PCR KIT

Generic name

Somatic gene mutation detection system

Applicant

QIAGEN GmbH

Date received

2014-11-19

Decision date

2014-12-19

Days to decision

30 days

Decision code

OK30

Product code

OWD

Advisory committee

Pathology

Expedited review

No

Location

Hilden

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).

510(k) clearances by this applicant