Cobas HCV Test

FDA PMAFDA 510(k)

Class II (US FDA PMA)

PMA P150015510(k) K221007

by Roche Molecular Systems, Inc.

Identity

Trade Name: COBAS HCV TEST 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: P150015 FDA PMA
510(k) Number: K221007 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: SESE Substantially Equivalent FDA PMA

The Cobas HCV Test is an in vitro nucleic acid amplification assay designed for the detection and quantitation of Hepatitis C virus (HCV) RNA in human EDTA plasma or serum. It is indicated for use in individuals with antibody evidence of HCV, including those with liver disease or suspected active infection, to aid in the diagnosis and management of patients undergoing anti-viral therapy.

This assay is validated for the detection and quantitation of HCV genotypes 1 through 6. It is intended to measure HCV RNA levels at baseline and throughout the course of treatment to determine viral response, though it is not approved for screening blood or blood products. Results must be interpreted by clinical professionals in the context of all relevant laboratory and clinical findings.

Frequently asked questions

What is the primary purpose of the Cobas HCV Test?

The test is used for the detection and quantitation of Hepatitis C virus RNA in human plasma or serum to aid in diagnosing active infection and managing patients undergoing anti-viral treatment.

Can this test be used to screen blood donations?

No, the Cobas HCV Test has not been approved for use as a screening test for the presence of HCV in blood or blood products.

Which HCV genotypes can the Cobas HCV Test detect?

The assay is validated for the detection and quantitation of HCV genotypes 1 through 6.

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: cobas® HCV - Roche Diagnostics, cobas® HCV - Roche Diagnostics, Multisite Performance Evaluation of the cobas 5800 System ..., Evaluation of the Roche COBAS AmpliPrep/COBAS TaqMan ..., [PDF] COBAS AMPLICOR HCV Test, v2.0 - accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K252484	Class II	Active
FDA 510(k)	United States	FDA_510K	K221007	Class II	Active
FDA PMA	United States	FDA_PMA	P150015	Class II	Active

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Manufacturer

Manufacturer: Roche Molecular Systems, Inc.

Sources (2)

FDA PMA P150015 37 fields · synced Sep 18, 2026
FDA 510(k) K252484 1 fields · synced May 18, 2026