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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Generic Nameroche amplicor hepatitis c virus (hcv) test version 2.0
PMA NumberP000010
Supplement NumberS007
Date Received02/15/2006
Decision Date06/22/2006
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the extension of the shelf life to 24 months of the hcv master mix, version 2,. 0, a component of the amplicor hcv test, v2. 0. The device, as modified, will be marketed under the trade name amplicor hcv test, v2. 0 and is indicated for the qualitative detection of hcv rna inhuman serum or plasma from blood collected in edta (edta plasma). The test detects by reverse transcribing target hcv rna in complimentary dna (cdna), amplifying cdna by polymerase chain reaction (pcr), hybridizing amplified cdna with an oligonucleotide probe that binds enzyme, and catalyzing conversion of substrate to a colored product that is recognized by a microwell plate reader. The amplicor hcv test, v2. 0 is indicated for patients who have evidence of liver disease and antibody evidence of hcv infection, and who are suspected to be actively infected with hcv. Detection of hcv rna indicates that the virus is replicating and therefore is evidence of active hcv infection.