cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more— 510(k) K260047
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K260047 for cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more, Substantially Equivalent on 2026-08-28. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Summary
This Roche Molecular Systems submission covers the cobas Strep A nucleic acid test for use on the cobas Liat System (07341911190) and a cobas Strep A quality control kit (07402678190). It's filed under PGX, Groups A, C and G beta-hemolytic Streptococcus nucleic acid amplification systems.
Class II, 21 CFR 866.2680. Microbiology is both the classification panel and the review panel, and the submission type is Traditional.
Pleasanton, California is the listed location. Review ran 233 calendar days, from January 7 to August 28, 2026, and ended in a substantially equivalent decision.
Clearance details
- Device name as filed
- cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Product code PGX
- Device class
- Class 2
- Regulation
- 21 CFR 866.2680
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code PGX
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- K253759 — cobas liat CT/NG/MG nucleic acid test
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