510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190515Substantially Equivalent

Aptima Combo 2 Assay (Panther System)

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

K190515 is the FDA 510(k) clearance record for Aptima Combo 2 Assay (Panther System), a class II device, cleared for Hologic, Inc. on under FDA product code QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections). FDA's definition for product code QEP reads: "A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in...". FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K190515.

Clearance record

Decision date
Received
(83 days to decision)
Product code
QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Regulation
21 CFR 866.3393
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 QEP

Trailing 12 months
3 clearances under product code QEP in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QEP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260