cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
FDA 510(k) clearance K213804 · decided 2022-10-22
Clearance details
- K-number
- K213804
- Device name
- cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-06
- Decision date
- 2022-10-22
- Days to decision
- 320 days
- Clearance type
- Traditional
- Product code
- QQX
- Device class
- 2
- Regulation number
- 866.3981
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Aptima SARS-CoV-2 Assay (K243396) | Hologic, Inc. | 2025-02-13 |
| cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (K240867) | Roche Molecular Systems, Inc. | 2025-02-11 |
| Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (K242109) | Cepheid® | 2025-01-15 |
| Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) (K241580) | Abbott Molecular | 2024-12-06 |
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (K233453) | Life Technologies Corporation | 2024-07-10 |
| Xpert® Xpress CoV-2 plus (K230440) | Cepheid® | 2023-10-13 |
| cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (K231306) | Roche Molecular Systems, Inc. | 2023-06-01 |
| Simplexa COVID-19 Direct (K212147) | Diasorin Molecular, LLC | 2022-09-13 |
| BioFire COVID-19 Test 2 (K221460) | Biofire Defense, LLC | 2022-07-25 |
| BioFire COVID-19 Test 2 (K211079) | Biofire Defense, LLC | 2021-11-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| cobas HPV (P190028/S023) | Roche Molecular Systems, Inc. | 2026-06-16 |
| cobas® HPV (P190028/S024) | Roche Molecular Systems, Inc. | 2026-04-23 |
| cobas® HPV (P190028/S025) | Roche Molecular Systems, Inc. | 2026-03-17 |
| cobas® KRAS Mutation Test (P140023/S032) | Roche Molecular Systems, Inc. | 2026-03-17 |
| cobas® HPV (P100020/S065) | Roche Molecular Systems, Inc. | 2026-03-17 |
| cobas® BRAF V600 Mutation Test (P110020/S044) | Roche Molecular Systems, Inc. | 2026-03-17 |
| cobas® HPV (P190028/S022) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobsa® BRAF V600 Mutation Test (P110020/S043) | Roche Molecular Systems, Inc. | 2025-12-31 |