FDA product code PEO: Fungal Organisms, Nucleic Acid-Based Assay
PEO is the FDA product code for fungal organisms, nucleic acid-based assay. It is a Class II device, regulated under 21 CFR 866.3365 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under PEO, 1 in the last five years, from 2 different applicants. The average 510(k) review took 88 days (median 88); 90 days on average over the last three years.
Definition
A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.
Classification
| Field | Value |
|---|---|
| Device name | Fungal Organisms, Nucleic Acid-Based Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.3365 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PEO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 85 |
| 2024 | 1 | 90 |
Compare with all 510(k) review times · Search every PEO clearance
Top PEO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luminex Corporation | 1 | 2024-06-04 |
| Genmark Diagnostics, Incorporated | 1 | 2018-12-21 |
Most recent PEO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240627 | Luminex Corporation | LIAISON PLEX Yeast Blood Culture Assay | 2024-06-04 | 90 |
| K182690 | Genmark Diagnostics, Incorporated | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | 2018-12-21 | 85 |
Recalls for PEO devices
openFDA lists no recalls for product code PEO.
Frequently asked questions
What is FDA product code PEO?
PEO is the FDA product code for fungal organisms, nucleic acid-based assay. It is a Class II device, regulated under 21 CFR 866.3365 and reviewed by the Microbiology panel.
What device class is PEO?
Class II, regulation 21 CFR 866.3365. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEO?
Across 2 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most PEO clearances?
Luminex Corporation (1); Genmark Diagnostics, Incorporated (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PEO
- Run a recall and safety report across every PEO manufacturer
- Watch product code PEO 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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