cobas HCV

FDA 510(k) K252484 · Roche Molecular Systems, Inc.

Substantially Equivalent

510(k) numberK252484

Submission

Device name
cobas HCV
Applicant
Roche Molecular Systems, Inc.
Pleasanton, CA, US
Received
August 7, 2025
Decision date
November 3, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MZP – Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3170
Specialty
Microbiology

Other 510(k)s with product code MZP

510(k)DeviceApplicantDecision
K252102Alinity m HCVMZP · Traditional Abbott Molecular, Inc.09/25/2025SE
K233352Aptima HCV Quant Dx AssayMZP · Traditional Hologic, Inc.07/24/2024SE
K221007cobas HCVMZP · Traditional Roche Molecular Systems, Inc.11/04/2022SE

More from Roche Molecular Systems, Inc.

510(k)DeviceDecision
K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…PGX · Traditional 08/28/2026SE
K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional 08/28/2026SE
K260021cobas® BV/CVPQA · Traditional 07/16/2026SE
K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…QEP · Traditional 07/08/2026SE
K253759cobas liat CT/NG/MG nucleic acid testQEP · Dual Track 05/15/2026SE
K253756cobas liat CT/NG nucleic acid testQEP · Dual Track 05/15/2026SE
K243753cobas liat Bordetella panel nucleic acid testOZZ · Dual Track 11/20/2025SE
K252481cobas CMVPAB · Traditional 11/03/2025SE
K243455cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional 07/31/2025SE
K243863Opulus™ Lymphoma PrecisionQIH · Traditional 05/30/2025SE

Questions and answers

When was cobas HCV cleared by the FDA?

cobas HCV (K252484) received a 510(k) decision of Substantially Equivalent on November 3, 2025, 88 days after the submission was received.

What is the product code of K252484?

The FDA product code is MZP – Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3170.