Cobas® Ampliprep/Cobas® Taqman® CMV Test (Cap/Ctm CMV Test)
FDA premarket approval P110037 · Cytomegalovirus (cmv) dna quantitative assay
Approval
- Applicant
- Roche Molecular Systems, Inc.
- Received
- October 24, 2011
- Decision date
- July 5, 2012 (APRL)
- Supplements
- 64, latest October 4, 2024
- Product code
- PAB – Cytomegalovirus (Cmv) Dna Quantitative Assay
Approval order statement
APPROVAL FOR THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST. THIS DEVICE IS INDICATED FOR: THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATIVE MEASUREMENT OF CYTOMEGALOVIRUS (CMV) DNA IN HUMAN EDTA PLASMA USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMENPROCESSING AND THE COBAS TAQMAN ANALYZER OR THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF SOLID-ORGAN TRANSPLANT PATIENTS WHO ARE UNDERGOING ANTI-CMV THERAPY. IN THIS POPULATION SERIAL DNA MEASUREMENTS CAN BE USED TO ASSESS VIROLOGICAL RESPONSE TO ANTIVIRAL TREATMENT. THE RESULTS FROM THE COBAS AMPLIPREP/COBAS TAQMAN CMVTEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF CMV DNA IN BLOOD OR BLOOD PRODUCTS.