Dna Probe, Nucleic Acid Amplification, Chlamydia
The DNA Probe Nucleic Acid Amplification test for Chlamydia is an in vitro diagnostic assay that uses amplification techniques such as PCR to detect Chlamydia trachomatis nucleic acids in urogenital specimens, enabling highly sensitive and specific diagnosis of chlamydial infections, the most common bacterial sexually transmitted infection. Classified as a Class 1 device under 21 CFR 866.3120 within the Microbiology specialty, it is subject to general controls and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.
Basic Information
- Product Code
- MKZ
- Device Class
- FDA class 1
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230451 | Aptima® Chlamydia trachomatis Assay | Nov 16, 2023 | Substantially Equivalent | Hologic, Inc. |
| K140446 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | May 20, 2014 | Substantially Equivalent | BECTON, DICKINSON & CO. |
| K110923 | COBAS 4800 CT / NG TEST | Jan 24, 2012 | Substantially Equivalent | ROCHE MOLECULAR SYSTEMS, INC. |
| K091724 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | Nov 13, 2009 | Substantially Equivalent | BECTON DICKINSON & CO. |
| K090824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | Jun 02, 2009 | Substantially Equivalent | BECTON, DICKINSON & CO. |
| K081824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | Dec 11, 2008 | Substantially Equivalent | BECTON, DICKINSON & CO. |
| K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT | Jul 10, 2008 | Substantially Equivalent | ABBOTT MOLECULAR, INC. |
| K070174 | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY | Apr 16, 2007 | Substantially Equivalent | ROCHE DIAGNOSTICS CORPORATION |
| K063451 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 | Jan 22, 2007 | Substantially Equivalent | GEN-PROBE, INC. |
| K061413 | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM | Oct 13, 2006 | Substantially Equivalent | GEN-PROBE, INC. |
| K053287 | COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Aug 10, 2006 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K053446 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 | Jul 25, 2006 | Substantially Equivalent | GEN-PROBE, INC. |
| K043072 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS | Jan 27, 2005 | Substantially Equivalent | GEN-PROBE, INC. |
| K973707 | ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Aug 04, 1999 | Substantially Equivalent | ROCHE MOLECULAR SYSTEMS, INC. |
| K973718 | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Dec 15, 1998 | Substantially Equivalent | ROCHE MOLECULAR SYSTEMS, INC. |
| K964507 | ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST | Jun 13, 1997 | Substantially Equivalent | ROCHE MOLECULAR SYSTEMS, INC. |
| K962217 | GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT | Nov 27, 1996 | Substantially Equivalent | GEN-PROBE, INC. |
| K934622 | LCX CHLAMYDIA TRACHOMATIS ASSAY | Dec 08, 1995 | Substantially Equivalent | ABBOTT LABORATORIES |
| K922906 | AMPLICOR CHLAMYDIA TRACHOMATIS TEST | Jun 15, 1993 | Substantially Equivalent | ROCHE MOLECULAR SYSTEMS, INC. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.