Identity
- Trade Name
- AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0 FDA PMA
- Generic Name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus FDA PMA
Identifiers
- PMA Number
- P000010 FDA PMA
- FDA Product Code
- MZP FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3170 FDA PMA
- Regulation Number
- 866.3170 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
The Amplicor Hepatitis C Virus (HCV) Test Version 2.0 is an in vitro nucleic acid amplification and hybridization assay designed for the qualitative detection of HCV RNA in human serum or EDTA plasma. It employs reverse transcription to convert HCV RNA into complementary DNA (cDNA), followed by polymerase chain reaction (PCR) amplification and hybridization with an enzyme-labeled oligonucleotide probe, producing a detectable colored signal for analysis via a microwell plate reader.
This test is intended for use in clinical microbiology settings to identify active HCV infection in patients with evidence of liver disease and prior HCV antibody positivity. Supplied as a single-use reagent kit, the device requires specialized laboratory equipment and trained personnel for operation. It is classified under FDA regulation 866.3170 and holds a Premarket Approval (PMA) designation (PMA Number: P000010), ensuring compliance with stringent validation and performance standards for diagnostic accuracy.
Frequently asked questions
What is the Amplicor HCV Test Version 2.0 specifically designed to detect in patient samples, and how does it work?
The Amplicor HCV Test Version 2.0 is designed to qualitatively detect HCV RNA in human serum or EDTA plasma, confirming active replication of the hepatitis C virus. It uses reverse transcription to convert HCV RNA into cDNA, followed by PCR amplification and hybridization with an enzyme-labeled probe. The reaction produces a colored signal detectable via a microwell plate reader, distinguishing active infection from past exposure.
Who is this test intended for, and what clinical context should it be used in?
This test is intended for patients who have evidence of liver disease and prior HCV antibody positivity, but are suspected of having active HCV infection. It is meant for clinical microbiology labs to confirm ongoing viral replication, not for initial screening or antibody testing alone.
Is the Amplicor HCV Test single-use, and what specialized equipment or training is required?
Yes, the Amplicor HCV Test is supplied as a single-use reagent kit, meaning each test requires a new kit. It requires specialized laboratory equipment (e.g., microwell plate readers) and trained personnel due to its nucleic acid amplification and hybridization methodology, which demands strict handling and interpretation protocols.
What sample types are compatible with this test, and are there any specific collection requirements?
The test is compatible with human serum or EDTA plasma collected from blood samples. EDTA plasma is explicitly mentioned in the authorized use, so samples must be collected in EDTA tubes to ensure compatibility with the assay.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P000010 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA PMA P000010 24 fields · synced Sep 18, 2026