510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243935Substantially Equivalent

Aptima CMV Quant Assay

Hologic, Inc., San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243935 is the FDA 510(k) clearance record for Aptima CMV Quant Assay, a class II device, cleared for Hologic, Inc. on under FDA product code PAB (Cytomegalovirus (Cmv) Dna Quantitative Assay). FDA's definition for product code PAB reads: "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...". FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K243935.

Clearance record

Decision date
Received
(28 days to decision)
Product code
PAB Cytomegalovirus (Cmv) Dna Quantitative Assay
Regulation
21 CFR 866.3180
Device class
Class II
Review panel
Microbiology
Applicant
Hologic, Inc. 10210 Genetic Center Dr., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PAB

Trailing 12 months
1 clearance under product code PAB in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PAB, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260