MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia
Microbiology · 21 CFR 866.3120 · Class 1
Overview
| Product Code | MKZ |
|---|---|
| Device Name | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Regulation | 21 CFR 866.3120 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Chlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).
Classification Rationale
Class I (general controls).
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230451 | Aptima® Chlamydia trachomatis Assay | Hologic, Inc. | Nov 16, 2023 | SESE |
| K140446 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | May 20, 2014 | SESE |
| K110923 | COBAS 4800 CT / NG TEST | Roche Molecular Systems, Inc. | Jan 24, 2012 | SESE |
| K091724 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | Nov 13, 2009 | SESE |
| K090824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | Jun 2, 2009 | SESE |
| K081824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | Dec 11, 2008 | SESE |
| K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT | Abbott Molecular, Inc. | Jul 10, 2008 | SESE |
| K070174 | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY | Roche Diagnostics Corporation | Apr 16, 2007 | SESE |
| K063451 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 | Gen-Probe, Inc. | Jan 22, 2007 | SESE |
| K061413 | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM | Gen-Probe, Inc. | Oct 13, 2006 | SESE |
| K053287 | COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Diagnostics Corp. | Aug 10, 2006 | SESE |
| K053446 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 | Gen-Probe, Inc. | Jul 25, 2006 | SESE |
| K043072 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS | Gen-Probe, Inc. | Jan 27, 2005 | SESE |
| K973707 | ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Molecular Systems, Inc. | Aug 4, 1999 | SESE |
| K973718 | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Molecular Systems, Inc. | Dec 15, 1998 | SESE |
| K964507 | ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST | Roche Molecular Systems, Inc. | Jun 13, 1997 | SESE |
| K962217 | GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT | Gen-Probe, Inc. | Nov 27, 1996 | SESE |
| K934622 | LCX CHLAMYDIA TRACHOMATIS ASSAY | Abbott Laboratories | Dec 8, 1995 | SESE |
| K922906 | AMPLICOR CHLAMYDIA TRACHOMATIS TEST | Roche Molecular Systems, Inc. | Jun 15, 1993 | SESE |
Top Applicants
- Gen-Probe, Inc. — 5 clearances
- Roche Molecular Systems, Inc. — 5 clearances
- Becton, Dickinson & CO — 4 clearances
- Abbott Laboratories — 1 clearance
- Abbott Molecular, Inc. — 1 clearance
