FDA product code PMN: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
PMN is the FDA product code for assayed external control material for microbiology nucleic acid amplification (nat) assays. It is a Class II device, regulated under 21 CFR 866.3920 and reviewed by the Microbiology panel. FDA has cleared 31 510(k) submissions under PMN, 15 in the last five years, from 8 different applicants. The average 510(k) review took 136 days (median 88); 83 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 4 recalls for PMN devices.
Definition
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Classification
| Field | Value |
|---|---|
| Device name | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays |
| Device class | Class II |
| Regulation | 21 CFR 866.3920 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PMN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 72 |
| 2018 | 3 | 57 |
| 2019 | 6 | 100 |
| 2020 | 2 | 92 |
| 2021 | 1 | 323 |
| 2022 | 3 | 451 |
| 2023 | 4 | 118 |
| 2024 | 2 | 78 |
| 2025 | 1 | 87 |
| 2026 | 5 | 83 |
Compare with all 510(k) review times · Search every PMN clearance
Top PMN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Maine Molecular Quality Controls, Inc. | 13 | 2026-05-19 |
| Microbiologics, Inc. | 8 | 2019-10-07 |
| Streck | 3 | 2026-03-23 |
| Biofire Defense, LLC | 2 | 2026-07-17 |
| Streck, LLC | 2 | 2026-03-27 |
3 more applicants have PMN clearances. See the full list in Caduvo.
Most recent PMN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261475 | Biofire Defense, LLC | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | 2026-07-17 | 73 |
| K260577 | Maine Molecular Quality Controls, Inc. | FilmArray TF Control Panel M527 | 2026-05-19 | 88 |
| K260041 | Streck, LLC | MDx-Chex for BCP | 2026-03-27 | 80 |
| K254166 | Streck | MDx-Chex for BCN | 2026-03-23 | 90 |
| K254167 | Streck, LLC | MDx-Chex for BCY | 2026-03-17 | 84 |
Recalls for PMN devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 3 still open. Most recent: 2019-05-16.
| Year | Recalls |
|---|---|
| 2019 | 4 |
Frequently asked questions
What is FDA product code PMN?
PMN is the FDA product code for assayed external control material for microbiology nucleic acid amplification (nat) assays. It is a Class II device, regulated under 21 CFR 866.3920 and reviewed by the Microbiology panel.
What device class is PMN?
Class II, regulation 21 CFR 866.3920. Typical premarket route: 510(k).
How long does a 510(k) take for product code PMN?
Across 31 cleared submissions the average was 136 days from receipt to decision (median 88).
Which companies have the most PMN clearances?
Maine Molecular Quality Controls, Inc. (13); Microbiologics, Inc. (8); Streck (3); Biofire Defense, LLC (2); Streck, LLC (2).
Have PMN devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2019-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code PMN
- Run a recall and safety report across every PMN manufacturer
- Watch product code PMN 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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