# PAM: Gram-Positive Bacteria And Their Resistance Markers

- Device class: 2; regulation: 21 CFR 866.3365; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 206 days (middle half 206–206)
- Recalls: 6 (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)
- 2012: 2
- 2016: 1
- 2017: 1
- 2018: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K122514: Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test (2012), cited by 4
- DEN120014: Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) (2012), cited by 2
- K181663: ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (2018), cited by 1

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