PMN — Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays Class II
FDA product code PMN covers "Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays", a Class II medical device regulated under 21 CFR 866.3920. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PMN
- Device Class
- Class II
- Regulation Number
- 866.3920
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261475 | biofire defense | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | July 17, 2026 |
| K260577 | maine molecular quality controls | FilmArray TF Control Panel M527 | May 19, 2026 |
| K260041 | streck | MDx-Chex for BCP | March 27, 2026 |
| K254166 | streck | MDx-Chex for BCN | March 23, 2026 |
| K254167 | streck | MDx-Chex for BCY | March 17, 2026 |
| K251526 | maine molecular quality controls | FilmArray GI Control Panel M238 | August 14, 2025 |
| K241289 | maine molecular quality controls | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | May 30, 2024 |
| K233611 | maine molecular quality controls | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), | March 26, 2024 |
| K231221 | streck | MDx-Chex for BC-GP | July 27, 2023 |
| K231223 | streck | MDx-Chex for BC-GN | July 27, 2023 |
| K230868 | maine molecular quality controls | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP | April 13, 2023 |
| K221253 | maine molecular quality controls | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | February 3, 2023 |
| K203680 | maine molecular quality controls | BioFire JI Control Panel M420 | July 22, 2022 |
| K201403 | zeptometrix | NATtrol BD MAX Vaginal Panel External Controls | February 2, 2022 |
| K212576 | streck | MDx-Chex for BCID2 | January 19, 2022 |
| K202196 | maine molecular quality controls | BioFire RP2.1/RP2.1plus Control Panel M441 | June 24, 2021 |
| K202382 | biofire defense | FilmArray Global Fever Panel External Control Kit | November 20, 2020 |
| K200010 | maine molecular quality controls | FilmArray BCID2 Control Panel M416 | April 2, 2020 |
| K190086 | microbiologics | Cepheid Xpert Respiratory Control Panel | October 7, 2019 |
| K191168 | microbiologics | Cepheid Xpert SA Nasal Complete Control Panel | June 25, 2019 |