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510(k) K200748

Visby Medical Sexual Health by Visby Medical — Product Code QEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2021
Date Received
March 23, 2020
Clearance Type
Dual Track
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 Visby Medical

  • K251501 — Visby Medical Men's Sexual Health Test (October 1, 2025)
  • DEN240020 — Visby Medical Women's Sexual Health Test (March 28, 2025)
  • K242526 — Visby Medical Respiratory Health Test (February 19, 2025)
  • K220407 — Visby Medical Sexual Health Test (March 7, 2023)

Other clearances for product code QEP

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  • 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)