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510(k) K202408

cobas CTNG for use on cobas 6800/8800 systems by Roche Molecular Systems, Inc. — Product Code QEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2021
Date Received
August 21, 2020
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.

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  • K243863 — Opulus™ Lymphoma Precision (May 30, 2025)
  • K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (April 25, 2025)
  • K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (April 25, 2025)
  • K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test (April 11, 2025)
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  • K240217 — cobas® liat CT/NG nucleic acid test (January 17, 2025)

Other clearances for product code QEP

  • K251501 — Visby Medical Men's Sexual Health Test (October 1, 2025)
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  • 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)