510(k) K182692

BD MAX CTGCTV2, BD MAX System by Becton, Dickinson and Company — Product Code OUY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 8, 2019
Date Received: September 27, 2018
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)
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)