# PMN: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

- Device class: 2; regulation: 21 CFR 866.3920; FDA's rule: 510(k) required
- FDA decisions: 33
- 510(k) review time 2021–2025: median 134 days (middle half 89–300)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 2
- 2018: 3
- 2019: 6
- 2020: 2
- 2021: 1
- 2022: 3
- 2023: 4
- 2024: 2
- 2025: 1
- 2026: 6

## Most-cited predicates
- K182472: Cepheid Xpert GBS LB Control Panel (2018), cited by 4
- DEN150058: Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak (2016), cited by 4
- K212576: MDx-Chex for BCID2 (2022), cited by 3
- K161573: FilmArray RP EZ Control Panel M265 (2016), cited by 3
- K202382: FilmArray Global Fever Panel External Control Kit (2020), cited by 2
- K200010: FilmArray BCID2 Control Panel M416 (2020), cited by 2
- K202196: BioFire RP2.1/RP2.1plus Control Panel M441 (2021), cited by 2
- K221253: SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (2023), cited by 1
- K163522: FilmArray Warrior Control Panel M290 (2017), cited by 1
- K231221: MDx-Chex for BC-GP (2023), cited by 1

Source page: https://510kreport.com/product-code/PMN
Data by year (CSV): https://510kreport.com/product-code/PMN.csv