COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
FDA 510(k) clearance K053289 · decided 2006-08-10
Clearance details
- K-number
- K053289
- Device name
- COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-25
- Decision date
- 2006-08-10
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- LSL
- Device class
- 2
- Regulation number
- 866.3390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Indianapolis, IN, 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 Neisseria gonorrhoeae Assay (K231329) | Hologic, Inc. | 2024-01-26 |
| Aptima Combo 2 Assay (Panther System) (K180681) | Hologic, Inc. | 2018-06-13 |
| cobas CT/NG for use on cobas 6800/8800 systems (K173887) | Roche Molecular Systems, Inc. | 2018-03-21 |
| Xpert CT/NG (K173840) | Cepheid | 2018-03-16 |
| cobas® CT/NG v2.0 Test (K163184) | Roche Molecular Systems, Inc. | 2017-02-09 |
| BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K140448) | Becton, Dickinson & CO | 2014-05-20 |
| ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG (K140354) | Abbott Molecular, Inc. | 2014-05-09 |
| COBAS CT/NG V2.0 TEST (K140887) | Roche Molecular Systems, Inc. | 2014-05-05 |
| COBAS CT/NG V2.0 TEST (K132270) | Roche Molecular Systems, Inc. | 2013-12-02 |
| APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) (K132251) | Hologic / Gen-Probe Incorporated | 2013-10-17 |
| XPERT CT/NG (K121710) | Cepheid | 2012-12-27 |
| APTIMA COMBO 2 ASSAY (K111409) | Gen-Probe, Inc. | 2012-05-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S046) | Roche Diagnostics Corp. | 2026-04-29 |
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S045) | Roche Diagnostics Corp. | 2026-04-29 |
| Elecsys total PSA assay (P990056/S045) | Roche Diagnostics Corp. | 2026-02-27 |
| Elecsys free PSA assay (P000027/S044) | Roche Diagnostics Corp. | 2026-02-27 |
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |