510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243396Substantially Equivalent

Aptima SARS-CoV-2 Assay

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

K243396 is the FDA 510(k) clearance record for Aptima SARS-CoV-2 Assay, a class II device, cleared for Hologic, Inc. on under FDA product code QQX (Respiratory Specimen Nucleic Acid Sars-Cov-2 Test). FDA's definition for product code QQX reads: "A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human...". FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K243396.

Clearance record

Decision date
Received
(105 days to decision)
Product code
QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Regulation
21 CFR 866.3981
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 QQX

Trailing 12 months

FDA records hold no clearances under product code QQX in the trailing twelve months.

FDA records show no clearances under product code QQX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QQX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260