Alinity m CMV

FDA 510(k) K243485 · Abbott Molecular, Inc.

Substantially Equivalent

510(k) numberK243485

Submission

Device name
Alinity m CMV
Applicant
Abbott Molecular, Inc.
Des Plaines, IL, US
Received
November 8, 2024
Decision date
July 1, 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
PAB – Cytomegalovirus (Cmv) Dna Quantitative Assay
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3180
Specialty
Microbiology

Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory…

Other 510(k)s with product code PAB

510(k)DeviceApplicantDecision
K252481cobas CMVPAB · Traditional Roche Molecular Systems, Inc.11/03/2025SE
K243935Aptima CMV Quant AssayPAB · Special Hologic, Inc.01/17/2025SE

More from Hologic, Inc.

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K252102Alinity m HCVMZP · Traditional 09/25/2025SE
K243489Alinity m EBV (09N43-095)QLX · Traditional 07/28/2025SE
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 CMV cleared by the FDA?

Alinity m CMV (K243485) received a 510(k) decision of Substantially Equivalent on July 1, 2025, 235 days after the submission was received.

What is the product code of K243485?

The FDA product code is PAB – Cytomegalovirus (Cmv) Dna Quantitative Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3180.