# PJE: Blood/Plasma Collection Device For Dna Testing

- Device class: 2; regulation: 21 CFR 862.1675; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 30 days (middle half 30–30)
- Recalls: 0 (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)
- 1998: 1
- 2001: 2
- 2002: 1
- 2003: 1
- 2005: 1
- 2015: 1
- 2023: 1

## Most-cited predicates
- K972075: Vacutainer Brand PPT Plasma Preparation Tube (1998), cited by 5
- K014104: Vacuette Edta K2 Tubes (2002), cited by 1
- K142821: PAXgene Blood DNA Tube (2015), cited by 1

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