510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161619Substantially Equivalent

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

Cepheid, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161619 is the FDA 510(k) clearance record for Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems, a class II device, cleared for Cepheid 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 62 510(k) clearances for Cepheid, from to . As of , FDA records show no recalls naming K161619.

Clearance record

Decision date
Received
(77 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
Cepheid 904 Carribean Dr., Sunnyvale 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