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510(k) K212213

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System by Cepheid — Product Code PQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2022
Date Received
July 15, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Device Class
Class II
Regulation Number
866.3975
Review Panel
MI
Submission Type

A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.

Other clearances by Cepheid

  • K253653 — Xpert Hemorrhagic Fever (February 20, 2026)
  • K251721 — Xpert GI Panel (January 16, 2026)
  • K250218 — Xpert® FII & FV (February 21, 2025)
  • K242071 — Xpert Xpress CoV-2/Flu/RSV plus (January 10, 2025)
  • DEN240016 — Xpert HCV; GeneXpert Xpress System (June 27, 2024)
  • K231381 — Xpert Xpress MVP; GeneXpert Xpress System (October 19, 2023)
  • K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (September 27, 2023)
  • K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (June 7, 2022)
  • K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (May 9, 2022)
  • K190076 — Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert I (September 27, 2019)

Other clearances for product code PQA

  • K243725 — BD Vaginal Panel (December 19, 2024)
  • K243345 — Aptima BV Assay; Aptima CV/TV Assay (November 25, 2024)
  • K231381 — Xpert Xpress MVP; GeneXpert Xpress System (October 19, 2023)
  • K223653 — BD Vaginal Panel (March 6, 2023)
  • K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (June 7, 2022)
  • K201017 — BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit (October 18, 2021)
  • K191957 — BD MAX Vaginal Panel (October 21, 2019)
  • K190452 — Aptima BV Assay (May 23, 2019)
  • K190472 — Aptima CV/TV Assay (May 16, 2019)
  • DEN160001 — BD MAX Vaginal Panel, BD MAX Instrument (October 28, 2016)