Alinity m HCV

FDA 510(k) K252102 · Abbott Molecular, Inc.

Substantially Equivalent

510(k) numberK252102

Submission

Device name
Alinity m HCV
Applicant
Abbott Molecular, Inc.
Des Plaines, IL, US
Received
July 3, 2025
Decision date
September 25, 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
K252484cobas HCVMZP · Traditional Roche Molecular Systems, Inc.11/03/2025SE
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
K243489Alinity m EBV (09N43-095)QLX · Traditional 07/28/2025SE
K243485Alinity m CMVPAB · Traditional 07/01/2025SE
K241921Alinity m BKVQMI · Traditional 03/24/2025SE
K241573Alinity m Resp-4-PlexQOF · Traditional 02/14/2025SE
K243410simpli-COLLECT STI TestQYA · Traditional 01/30/2025SE
K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)QQX · Traditional 12/06/2024SE
K233349Alinity m HSV 1 & 2 / VZVPGI · Traditional 05/03/2024SE
K222379Alinity m STI AssayQEP · Traditional 03/03/2023SE
K212778Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085)…QLX · Traditional 07/15/2022SE
K202977Alinity m STI AssayQEP · Traditional 04/29/2022SE

Questions and answers

When was Alinity m HCV cleared by the FDA?

Alinity m HCV (K252102) received a 510(k) decision of Substantially Equivalent on September 25, 2025, 84 days after the submission was received.

What is the product code of K252102?

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.