FDA product code MKZ: Dna Probe, Nucleic Acid Amplification, Chlamydia
MKZ is the FDA product code for dna probe, nucleic acid amplification, chlamydia. It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel. FDA has cleared 19 510(k) submissions under MKZ, 1 in the last five years, from 8 different applicants. The average 510(k) review took 247 days (median 170). FDA has posted 3 recalls for MKZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Device class | Class I |
| Regulation | 21 CFR 866.3120 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MKZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 268 |
Compare with all 510(k) review times · Search every MKZ clearance
Top MKZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Molecular Systems, Inc. | 5 | 2012-01-24 |
| Gen-Probe, Inc. | 5 | 2007-01-22 |
| Becton, Dickinson & CO | 4 | 2014-05-20 |
| Hologic, Inc. | 1 | 2023-11-16 |
| Abbott Molecular, Inc. | 1 | 2008-07-10 |
3 more applicants have MKZ clearances. See the full list in Caduvo.
Most recent MKZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230451 | Hologic, Inc. | Aptima® Chlamydia trachomatis Assay | 2023-11-16 | 268 |
| K140446 | Becton, Dickinson & CO | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | 2014-05-20 | 88 |
| K110923 | Roche Molecular Systems, Inc. | COBAS 4800 CT / NG TEST | 2012-01-24 | 298 |
| K091724 | Becton, Dickinson & CO | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | 2009-11-13 | 155 |
| K090824 | Becton, Dickinson & CO | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | 2009-06-02 | 68 |
Recalls for MKZ devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-09-29.
Frequently asked questions
What is FDA product code MKZ?
MKZ is the FDA product code for dna probe, nucleic acid amplification, chlamydia. It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel.
What device class is MKZ?
Class I, regulation 21 CFR 866.3120. Typical premarket route: 510(k).
How long does a 510(k) take for product code MKZ?
Across 19 cleared submissions the average was 247 days from receipt to decision (median 170).
Which companies have the most MKZ clearances?
Roche Molecular Systems, Inc. (5); Gen-Probe, Inc. (5); Becton, Dickinson & CO (4); Hologic, Inc. (1); Abbott Molecular, Inc. (1).
Have MKZ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2010-09-29.
Next steps
- Run an FDA pathway report with predicate devices for product code MKZ
- Run a recall and safety report across every MKZ manufacturer
- Watch product code MKZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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