FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
K Number: K240867
·
Decision Feb 11, 2025
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
10
Applicant Total
51
Review Days
319
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Basic Information
- Device Name
- cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
- K Number
- K240867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3981
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Molecular Systems, Inc.
- Date Received
- March 29, 2024
- Decision Date
- February 11, 2025
- Product Code
- QQX
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | FDA class 2 | Microbiology |
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Other Clearances by Roche Molecular Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253756 | cobas liat CT/NG nucleic acid test | May 15, 2026 | Substantially Equivalent |
| K253759 | cobas liat CT/NG/MG nucleic acid test | May 15, 2026 | Substantially Equivalent |
| K243753 | cobas liat Bordetella panel nucleic acid test | Nov 20, 2025 | Substantially Equivalent |
| K252484 | cobas HCV | Nov 3, 2025 | Substantially Equivalent |
| K252481 | cobas CMV | Nov 3, 2025 | Substantially Equivalent |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | Jul 31, 2025 | Substantially Equivalent |
| K243863 | Opulus Lymphoma Precision | May 30, 2025 | Substantially Equivalent |
| K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Apr 25, 2025 | Substantially Equivalent |
| K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Apr 25, 2025 | Substantially Equivalent |
| K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | Apr 11, 2025 | Substantially Equivalent |