THERASCREEN EGFR RGQ PCR KIT

FDA premarket approval P120022/S005 · decided 2015-01-16

Approval details

PMA number

P120022

Supplement

S005

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

2014-12-22

Decision date

2015-01-16

Days to decision

25 days

Decision code

OK30

Product code

OWD

Advisory committee

Pathology

Expedited review

No

Location

Hilden

Statement

CHANGE TO THE SUPPLIER¿S PURITY TESTING METHOD FOR THE INTERNAL CONTROL TEMPLATE IN YOUR THERASCREEN EGFR 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%.

510(k) clearances by this applicant