Cobas Ampliprep/Cobas Taqman HCV Test
FDA premarket approval P060030 · Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval
- Applicant
- Roche Molecular Systems, Inc.
- Received
- October 27, 2006
- Decision date
- October 30, 2008 (APRL)
- Supplements
- 83, latest August 11, 2021
- Product code
- MZP – Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Approval order statement
APPROVAL FOR THE COBASAMPLIPREP/COBAS TAQMAN HCV TEST. THIS DEVICE IS AN IN VITRO NUCLEIC ACID AMPLIFICATION LESTFOR THE QUANTITATION OF HEPATITIS C VIRAL (HCV) RNA IN HUMAN PLASMA OR SERUM OF HCV-INFECTEDINDIVIDUALS USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSING AND THECOBAS TAQMAN ANALYZER OR THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION ANDDETECTION. SPECIMENS CONTAINING HCV GENOTYPES 1 - 6 HAVE BEEN VALIDATED FOR QUANTITATION INTHE ASSAY. THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST IS INTENDED FOR USE AS AN AID IN THEMANAGEMENT OF HCV-INFECTED INDIVIDUALS UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY MEASURESHCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND CAN BE UTILIZED TO PREDICT SUSTAINED ANDNON-SUSTAINED VIROLOGICAL RESPONSE TO HCV THERAPY. THE RESULTS FROM THE COBASAMPIPREP/COBAS TAQMAN HCV TEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN. NO INFORMATION IS AVAILABLE ON THE ASSAY'S PREDICTIVE VALUE WHEN OTHER THERAPIES ARE USED. ASSAY PERFORMANCE FOR DETERMINING THE SLATE OF HCV INFECTION HAS NOT BEEN ESTABLISHED."