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510(k) K122062

APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER by Gen-Probe, Inc. — Product Code OUY

K122062 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER". The FDA issued a decision of Substantially Equivalent on January 9, 2013. The device falls under product code OUY (Trichomonas Vaginalis Nucleic Acid Amplification Test System), a Class II device regulated under 21 CFR 866.3860. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2013
Date Received
July 13, 2012
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

Other clearances by Gen-Probe, Inc.

  • K111409 — APTIMA COMBO 2 ASSAY (May 3, 2012)
  • K063664 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 (January 25, 2007)
  • K063451 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (January 22, 2007)
  • K062440 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 (November 7, 2006)
  • K061413 — APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (October 13, 2006)
  • K061509 — TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 (October 4, 2006)
  • K060652 — TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY (August 17, 2006)
  • K053446 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (July 25, 2006)
  • K043224 — GEN-PROBE APTIMA COMBO 2 ASSAY (August 9, 2005)
  • K043144 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE (March 14, 2005)

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)
  • 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)
  • DEN110012 — APTIMA TRICHOMONAS VAGINALIS ASSAY (April 19, 2011)

FDA data resources