PMN
- Product code
- PMN
- Device name
- Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3920
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 32 (all years; only the last 3 years are listed here)
FDA classification definition
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261475 | 2026-07-17 | Biofire Defense, LLC | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | |
| K260577 | 2026-05-19 | Maine Molecular Quality Controls, Inc. | FilmArray TF Control Panel M527 | |
| K260041 | 2026-03-27 | Streck, LLC | MDx-Chex for BCP | FDA |
| K254166 | 2026-03-23 | Streck | MDx-Chex for BCN | |
| K254167 | 2026-03-17 | Streck, LLC | MDx-Chex for BCY | |
| K251526 | 2025-08-14 | Maine Molecular Quality Controls, Inc. | FilmArray GI Control Panel M238 | |
| K241289 | 2024-05-30 | Maine Molecular Quality Controls, Inc. | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negati… | |
| K233611 | 2024-03-26 | Maine Molecular Quality Controls, Inc. | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP… |
Official FDA classification page: PMN
Classification and pathway per current FDA publications. Data from openFDA (CC0).