FDA product code PLO: Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
PLO is the FDA product code for meningitis/encephalitis pathogen multiplex nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3970 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under PLO, 1 in the last five years, from 3 different applicants. The average 510(k) review took 72 days (median 90); 90 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 2 recalls for PLO devices.
Definition
A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical and other laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System |
| Device class | Class II |
| Regulation | 21 CFR 866.3970 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PLO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 98 |
| 2024 | 1 | 90 |
Compare with all 510(k) review times · Search every PLO clearance
Top PLO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| QIAGEN GmbH | 1 | 2024-10-29 |
| Diasorin Molecular, LLC | 1 | 2019-05-13 |
| Biofire Diagnostics, LLC | 1 | 2016-03-17 |
Most recent PLO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242256 | QIAGEN GmbH | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | 2024-10-29 | 90 |
| K190219 | Diasorin Molecular, LLC | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | 2019-05-13 | 98 |
| K160462 | Biofire Diagnostics, LLC | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch | 2016-03-17 | 27 |
Recalls for PLO devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-05-12.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code PLO?
PLO is the FDA product code for meningitis/encephalitis pathogen multiplex nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3970 and reviewed by the Microbiology panel.
What device class is PLO?
Class II, regulation 21 CFR 866.3970. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLO?
Across 3 cleared submissions the average was 72 days from receipt to decision (median 90).
Which companies have the most PLO clearances?
QIAGEN GmbH (1); Diasorin Molecular, LLC (1); Biofire Diagnostics, LLC (1).
Have PLO devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2020-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code PLO
- Run a recall and safety report across every PLO manufacturer
- Watch product code PLO 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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