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510(k) K190441

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit by Cepheid — Product Code QEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2019
Date Received
February 25, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Device Class
Class II
Regulation Number
866.3393
Review Panel
MI
Submission Type

A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.

Other clearances by Cepheid

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  • 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)
  • K212213 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (February 9, 2022)

Other clearances for product code QEP

  • K251501 — Visby Medical Men's Sexual Health Test (October 1, 2025)
  • K243343 — BD CTGCTV2 (April 22, 2025)
  • K240217 — cobas® liat CT/NG nucleic acid test (January 17, 2025)
  • K240197 — cobas® liat CT/NG/MG nucleic acid test (January 16, 2025)
  • K230267 — NeuMoDx CT/NG Assay 2.0 (December 22, 2023)
  • K220407 — Visby Medical Sexual Health Test (March 7, 2023)
  • K222379 — Alinity m STI Assay (March 3, 2023)
  • K220321 — Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) (June 3, 2022)
  • K210585 — BD CTGCTV2 (May 10, 2022)
  • K202977 — Alinity m STI Assay (April 29, 2022)