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510(k) K240217

cobas® liat CT/NG nucleic acid test by Roche Molecular Systems, Inc. — Product Code QEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2025
Date Received
January 26, 2024
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.

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  • K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test (April 11, 2025)
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  • K240197 — cobas® liat CT/NG/MG nucleic acid test (January 16, 2025)

Other clearances for product code QEP

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  • 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)
  • K193081 — Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and soft (December 17, 2021)