APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
FDA 510(k) clearance K132251 · decided 2013-10-17
Clearance details
- K-number
- K132251
- Device name
- APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
- Applicant
- Hologic / Gen-Probe Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2013-07-19
- Decision date
- 2013-10-17
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LSL
- Device class
- 2
- Regulation number
- 866.3390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, 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 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 |
| XPERT CT/NG (K121710) | Cepheid | 2012-12-27 |
| APTIMA COMBO 2 ASSAY (K111409) | Gen-Probe, Inc. | 2012-05-03 |
| BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K091730) | Becton, Dickinson & CO | 2009-11-13 |
Recalls involving this device
No recalls on record reference this clearance.