BD Probetec Chlamydia Trachomatis (CT) QX Amplified DNA Assay
FDA 510(k) K140446 · Becton, Dickinson & CO
510(k) numberK140446
Submission
- Device name
- BD Probetec Chlamydia Trachomatis (CT) QX Amplified DNA Assay
- Applicant
- Becton, Dickinson & CO
Sparks, MD, US - Received
- February 21, 2014
- Decision date
- May 20, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MKZ – Dna Probe, Nucleic Acid Amplification, Chlamydia
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Specialty
- Microbiology
Other 510(k)s with product code MKZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230451 | Aptima® Chlamydia trachomatis AssayMKZ · Traditional | Hologic, Inc. | 11/16/2023SE |
| K110923 | Cobas 4800 CT / NG TestMKZ · Traditional | Roche Molecular Systems, Inc. | 01/24/2012SE |
| K091724 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified DNA AssayMKZ · Traditional | Becton, Dickinson & CO | 11/13/2009SE |
| K090824 | BD Probetec Chlamydia Trachomatis (CT) QX Amplified DNA AssayMKZ · Traditional | Becton, Dickinson & CO | 06/02/2009SE |
| K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified DNA AssayMKZ · Traditional | Becton, Dickinson & CO | 12/11/2008SE |
| K080739 | Abbott Realtime Ct/Ng Assay and Multi-Collect Specimen Collection KitMKZ · Traditional | Abbott Molecular, Inc. | 07/10/2008SE |
| K070174 | Amplicor Ct/Ng Test for Chlamydia Trachomatis; Roche Scripts for Ct/Ng Test AccessoryMKZ · Traditional | Roche Diagnostics Corporation | 04/16/2007SE |
| K063451 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199MKZ · Traditional | Gen-Probe, Inc. | 01/22/2007SE |
| K061413 | Aptima CT Assay on the Tigris DTS SystemMKZ · Traditional | Gen-Probe, Inc. | 10/13/2006SE |
| K053287 | Cobas Amplicor Ct/Ng Test for Chlamydia TrachomatisMKZ · Traditional | Roche Diagnostics Corp. | 08/10/2006SE |
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| K150059 | BD FlowSmart SetFPA · Traditional | 04/28/2015SE |
| K141474 | Becton Dickinson Intelliport SystemPHC · Traditional | 12/18/2014SE |
| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | 05/20/2014SE |
Questions and answers
When was BD Probetec Chlamydia Trachomatis (CT) QX Amplified DNA Assay cleared by the FDA?
BD Probetec Chlamydia Trachomatis (CT) QX Amplified DNA Assay (K140446) received a 510(k) decision of Substantially Equivalent on May 20, 2014, 88 days after the submission was received.
What is the product code of K140446?
The FDA product code is MKZ – Dna Probe, Nucleic Acid Amplification, Chlamydia, a Class I (low risk) device regulated under 21 CFR 866.3120.