510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K122062Substantially Equivalent

Aptima Trichomonas Vaginalis Assay - Panther

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

K122062 is the FDA 510(k) clearance record for APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER, a class II device, cleared for Gen-Probe, Inc. on under FDA product code OUY (Trichomonas Vaginalis Nucleic Acid Amplification Test System). FDA's definition for product code OUY reads: "In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic...". FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K122062.

Clearance record

Decision date
Received
(180 days to decision)
Product code
OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
Regulation
21 CFR 866.3860
Device class
Class II
Review panel
Immunology
Applicant
Gen-Probe, Inc. 10210 Genetic Center Dr., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUY

Trailing 12 months

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

FDA records show no clearances under product code OUY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUY, 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