cobas liat Bordetella panel nucleic acid test
FDA 510(k) clearance K243753 · decided 2025-11-20
Clearance details
- K-number
- K243753
- Device name
- cobas liat Bordetella panel nucleic acid test
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-05
- Decision date
- 2025-11-20
- Days to decision
- 350 days
- Clearance type
- Dual Track
- Product code
- OZZ
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K183223) | Diasorin Molecular, LLC | 2018-12-19 |
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K173498) | Diasorin Molecular, LLC | 2018-08-13 |
| Solana Bordetella Complete Assay (K181029) | Quidel Corporation | 2018-07-15 |
| ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (K163626) | Luminex Corporation | 2017-05-02 |
| Great Basin Bordetella Direct Test (K170284) | Great Basin Scientific, Inc. | 2017-03-31 |
| illumigene Pertussis DNA Amplification Assay (K152285) | Meridian Bioscience, Inc. | 2015-11-10 |
| AmpliVue Bordetella Assay (K143206) | Quidel Corporation | 2014-12-10 |
| ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA (K133673) | Meridian Bioscience, Inc. | 2014-03-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| cobas® KRAS Mutation Test (P140023/S031) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobas® HPV (P100020/S064) | Roche Molecular Systems, Inc. | 2025-12-31 |
| COBAS HPV TEST (P100020/S063) | Roche Molecular Systems, Inc. | 2025-12-15 |
| cobas® HBV (P150014/S056) | Roche Molecular Systems, Inc. | 2025-10-17 |
| cobas HPV (P190028/S021) | Roche Molecular Systems, Inc. | 2025-09-19 |
| cobas HBV (P150014/S058) | Roche Molecular Systems, Inc. | 2025-09-19 |