FDA product code OZX: Mycoplasma Pneumoniae Dna Assay System
OZX is the FDA product code for mycoplasma pneumoniae dna assay system. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under OZX. The average 510(k) review took 105 days (median 80).
Definition
A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.
Classification
| Field | Value |
|---|---|
| Device name | Mycoplasma Pneumoniae Dna Assay System |
| Device class | Class II |
| Regulation | 21 CFR 866.3980 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Top OZX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Bioscience, Inc. | 3 | 2016-06-13 |
Most recent OZX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160829 | Meridian Bioscience, Inc. | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 | 2016-06-13 | 80 |
| K152800 | Meridian Bioscience, Inc. | illumigene Mycoplasma DNA Amplification Assay | 2015-10-23 | 25 |
| K123423 | Meridian Bioscience, Inc. | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT | 2013-06-05 | 211 |
Recalls for OZX devices
openFDA lists no recalls for product code OZX.
Frequently asked questions
What is FDA product code OZX?
OZX is the FDA product code for mycoplasma pneumoniae dna assay system. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel.
What device class is OZX?
Class II, regulation 21 CFR 866.3980. Typical premarket route: 510(k).
How long does a 510(k) take for product code OZX?
Across 3 cleared submissions the average was 105 days from receipt to decision (median 80).
Which companies have the most OZX clearances?
Meridian Bioscience, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code OZX
- Run a recall and safety report across every OZX manufacturer
- Watch product code OZX 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.