510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143329Substantially Equivalent

AmpliVue Trichomonas Assay

Ortho-Clinical Diagnostics, Inc., Athens OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143329 is the FDA 510(k) clearance record for AmpliVue Trichomonas Assay, a class II device, cleared for Quidel Corporation 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 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K143329.

Clearance record

Decision date
Received
(117 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
Quidel Corporation 2005 E. State St., Suite 100, Athens OH
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