Versant HCV RNA Qualitative Assay

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Aptima Hcv RNA Qualitative Assay

Trade Name

Versant Hcv RNA Qualitative Assay

Generic Name

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

PMA Number

P020011 ↗

FDA Product Code

MZP

Device Class

Class II

Regulation

21 CFR Part 866.3170

Advisory Committee

Microbiology

FDA Decision

APRL

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• What types of specimens can be tested using the Versant HCV RNA Qualitative Assay, and how should they be prepared?

  The assay is designed for use with human plasma (collected in EDTA, sodium heparin, sodium citrate, or ACD) or serum. Specimens can be either fresh or frozen, ensuring compatibility with individuals who may have been tested previously or require retrospective analysis. Proper handling and storage are critical to maintain assay integrity, as the kit is single-use and intended for molecular detection of active HCV infection.

• Who is this assay intended for, and how does it differ from standard HCV antibody testing?

  This assay is specifically intended for individuals with antibody evidence of HCV infection who also have liver disease, those suspected of active HCV infection with antibody evidence, or those at risk for HCV infection with detectable antibodies. Unlike antibody tests, which indicate past exposure, this assay detects active HCV infection by identifying viral RNA, distinguishing current infection from historical exposure.

• Is the Versant HCV RNA Qualitative Assay reusable, and what storage conditions are required to maintain its performance?

  No, the assay is supplied as a single-use diagnostic kit, meaning each test requires a new kit. Sterility and proper storage conditions are essential to preserve assay integrity. While specific storage details aren’t provided, typical nucleic acid amplification assays require protection from extreme temperatures, light, and contamination—consult the manufacturer’s instructions for precise guidelines.

• What regulatory pathway was followed for this assay, and what class does it fall under?

  The assay was approved via the FDA’s Premarket Approval (PMA) pathway, with PMA number P020011. It is classified as a Class II medical device under the MZP product code, indicating it carries a moderate risk level requiring special controls to ensure safety and effectiveness.