Identity
- Trade Name
- VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA) FDA PMA
- Generic Name
- Assay, genotyping, hepatitis c virus FDA PMA
Identifiers
- PMA Number
- P160016 FDA PMA
- FDA Product Code
- OBF 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
- APRL FDA PMA
The Versant HCV Genotype 2.0 Assay (LiPA) is a line probe assay classified as an assay, genotyping, hepatitis C virus. It identifies Hepatitis C virus (HCV) genotypes 1 through 6 and subtypes 1a and 1b in human serum or plasma samples collected in K2EDTA, ACD-A, CPD, or CPDA anticoagulants. This in vitro diagnostic device aids in the classification of HCV strains to support treatment decision-making for patients with chronic HCV infection.
The assay is supplied as a line probe assay kit for laboratory use and is intended for single-use only. It requires no special storage conditions beyond refrigeration and is designed for use in microbiology settings. Authorized under FDA PMA (P160016), the device adheres to regulatory standards for in vitro diagnostics, ensuring compliance with classification 2 medical devices and microbiology specialty requirements.
Frequently asked questions
What types of patient samples can be tested with the VERSANT HCV Genotype 2.0 Assay (LiPA), and why are these specific anticoagulants required?
The assay is designed to analyze human serum or plasma samples collected using K2EDTA, ACD-A, CPD, or CPDA anticoagulants. These specific anticoagulants are required because they preserve the integrity of the Hepatitis C virus (HCV) RNA and prevent degradation, ensuring accurate genotyping results for HCV genotypes 1 through 6 and subtypes 1a and 1b.
Is the VERSANT HCV Genotype 2.0 Assay (LiPA) intended for repeated use in the same patient, or is it meant for single-use only?
The device is explicitly labeled for single-use only, meaning each kit should be used for one test on a single patient sample. This ensures consistency, sterility, and reliability of results without cross-contamination risks.
What storage conditions are required for the VERSANT HCV Genotype 2.0 Assay (LiPA), and why is this important?
The assay requires standard refrigeration storage, with no additional specialized conditions needed. This is important because refrigeration helps maintain the stability of the reagents and probes within the kit, ensuring accurate and reliable genotyping performance over its shelf life.
How does the VERSANT HCV Genotype 2.0 Assay (LiPA) support clinical decision-making for patients with chronic HCV infection?
The assay identifies HCV genotypes 1–6 and subtypes 1a/1b in serum or plasma, enabling precise classification of viral strains. This classification aids clinicians in selecting the most effective antiviral treatment regimen tailored to the specific genotype, improving patient outcomes by optimizing therapy selection.
What regulatory pathway was followed for the approval of the VERSANT HCV Genotype 2.0 Assay (LiPA), and what does this mean for its use?
The device was approved via the FDA’s Premarket Approval (PMA) pathway under PMA number P160016, which is required for high-risk medical devices like this in vitro diagnostic assay. This means it has undergone rigorous review to ensure safety, effectiveness, and compliance with FDA standards for classifying HCV genotypes, ensuring reliable use in microbiology labs for treatment guidance.
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. Sources consulted: INNO-LiPA® HCV 2.0 Genotyping | Fujirebio, Fujirebio Europe launches the INNO-LiPA® HCV 2.0 Genotyping assay, an ..., VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA) (P160016) - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160016 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujirebio Europe N.V.
Sources (1)
- FDA PMA P160016 24 fields · synced Sep 18, 2026