Aptima CMV Quant Assay

FDA 510(k) K243935 · Hologic, Inc.

Substantially Equivalent

510(k) numberK243935

Submission

Device name
Aptima CMV Quant Assay
Applicant
Hologic, Inc.
San Diego, CA, US
Received
December 20, 2024
Decision date
January 17, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 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…

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Questions and answers

When was Aptima CMV Quant Assay cleared by the FDA?

Aptima CMV Quant Assay (K243935) received a 510(k) decision of Substantially Equivalent on January 17, 2025, 28 days after the submission was received.

What is the product code of K243935?

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