cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems— 510(k) K260917
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K260917 for cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems, Substantially Equivalent on 2026-07-08. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Summary
Roche Molecular Systems' clearance covers cobas CT/NG and cobas TV/MG, both for use on the cobas 5800/6800/8800 systems. They're filed under QEP, nucleic acid detection systems for non-viral microorganisms causing sexually transmitted infections.
Class II, 21 CFR 866.3393. Microbiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Roche filed from Pleasanton, California. Review took 111 calendar days (March 19 to July 8, 2026).
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Product code QEP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3393
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code QEP
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