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510(k) K231316

Aptima Trichomonas vaginalis Assay by Hologic, Inc. — Product Code OUY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2023
Date Received
May 8, 2023
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

  • K182692 — BD MAX CTGCTV2, BD MAX System (January 8, 2019)
  • K151589 — BD MAX CT/GC/TV, BD MAX INSTRUMENT (September 6, 2016)
  • K161619 — Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II (August 29, 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)