PMN — Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays Class II
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 |
|---|---|---|---|
| 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 |
| K191172 | microbiologics | Cepheid Xpert MRSA NxG Control Panel | June 20, 2019 |
| K190223 | microbiologics | Cepheid Xpert CT/NG Control Panel | May 8, 2019 |
| K190222 | maine molecular quality controls | FilmArray Pneumonia/Pneumoniaplus Control | May 3, 2019 |
| K190463 | microbiologics | Cepheid Xpert C. difficile/Epi Control Panel | April 19, 2019 |
| K182472 | microbiologics | Cepheid Xpert GBS LB Control Panel | November 8, 2018 |