cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more— 510(k) K260045
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K260045 for cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more, Substantially Equivalent on 2026-08-28. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Summary
Roche Molecular Systems filed the cobas Cdiff nucleic acid test for use on the cobas Liat System (07454945190), along with a cobas Cdiff positive and negative control kit (07454970190). The product code is OZN, C. difficile toxin gene amplification assays.
Class II, 21 CFR 866.3130. Microbiology is both the classification panel and the review panel. It was a Traditional 510(k).
Roche filed from Pleasanton, California. The decision came 233 calendar days after receipt (January 7 to August 28, 2026), and it was substantially equivalent.
Clearance details
- Device name as filed
- cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Product code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code OZN
view allMore clearances from Roche Molecular Systems, Inc.
view all- K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more
- K260021 — cobas® BV/CV
- K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- K253756 — cobas liat CT/NG nucleic acid test
- K253759 — cobas liat CT/NG/MG nucleic acid test
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