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510(k) DEN110012

APTIMA TRICHOMONAS VAGINALIS ASSAY by Gen-Probe Incorporated — Product Code OUY

DEN110012 is an FDA 510(k) premarket notification submitted by Gen-Probe Incorporated for the device "APTIMA TRICHOMONAS VAGINALIS ASSAY". The FDA issued a decision of De Novo Granted on April 19, 2011. The device falls under product code OUY (Trichomonas Vaginalis Nucleic Acid Amplification Test System), a Class II device regulated under 21 CFR 866.3860.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 19, 2011
Date Received
April 13, 2011
Clearance Type
Post-NSE
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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  • 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)

FDA data resources