LSL · Dna-Reagents, Neisseria
Microbiology · 21 CFR 866.3390 · Class 2
Overview
| Product Code | LSL |
|---|---|
| Device Name | Dna-Reagents, Neisseria |
| Regulation | 21 CFR 866.3390 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231329 | Aptima Neisseria gonorrhoeae Assay | Hologic, Inc. | Jan 26, 2024 | SESE |
| K180681 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | Jun 13, 2018 | SESE |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | Mar 21, 2018 | SESE |
| K173840 | Xpert CT/NG | Cepheid | Mar 16, 2018 | SESE |
| K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | Feb 9, 2017 | SESE |
| K140448 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | May 20, 2014 | SESE |
| K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | Abbott Molecular, Inc. | May 9, 2014 | SESE |
| K140887 | COBAS CT/NG V2.0 TEST | Roche Molecular Systems, Inc. | May 5, 2014 | SESE |
| K132270 | COBAS CT/NG V2.0 TEST | Roche Molecular Systems, Inc. | Dec 2, 2013 | SESE |
| K132251 | APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) | Hologic / Gen-Probe Incorporated | Oct 17, 2013 | SESE |
| K121710 | XPERT CT/NG | Cepheid | Dec 27, 2012 | SESE |
| K111409 | APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | May 3, 2012 | SESE |
| K091730 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | Nov 13, 2009 | SESE |
| K090971 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | Jun 5, 2009 | SESE |
| K090827 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | May 27, 2009 | SESE |
| K081825 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | Dec 11, 2008 | SESE |
| K070172 | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Diagnostics Corporation | Apr 17, 2007 | SESE |
| K063664 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 | Gen-Probe, Inc. | Jan 25, 2007 | SESE |
| K062440 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 | Gen-Probe, Inc. | Nov 7, 2006 | SESE |
| K061509 | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 | Gen-Probe, Inc. | Oct 4, 2006 | SESE |
Top Applicants
- Gen-Probe, Inc. — 15 clearances
- Becton, Dickinson & CO — 8 clearances
- Roche Molecular Systems, Inc. — 6 clearances
- Digene Corp. — 3 clearances
- Cepheid — 2 clearances
