Home / 510(k) Clearances / K161619

510(k) K161619

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 by Cepheid — Product Code OUY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2016
Date Received
June 13, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Device Class
Class II
Regulation Number
866.3860
Review Panel
MI
Submission Type

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 patients

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Other clearances for product code OUY

  • K231316 — Aptima Trichomonas vaginalis Assay (November 6, 2023)
  • K182692 — BD MAX CTGCTV2, BD MAX System (January 8, 2019)
  • K151589 — BD MAX CT/GC/TV, BD MAX INSTRUMENT (September 6, 2016)
  • K161182 — Solana Trichomonas Assay (August 15, 2016)
  • K151565 — Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneX (October 16, 2015)
  • K143329 — AmpliVue Trichomonas Assay (March 17, 2015)
  • K130268 — BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY (August 23, 2013)
  • K122062 — APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (January 9, 2013)
  • DEN110012 — APTIMA TRICHOMONAS VAGINALIS ASSAY (April 19, 2011)