PJE
8 FDA 510(k) clearances · Product code
135 daysmedian time to decision
344 days90th percentile
8clearances measured
FDA profile
- Official device name
- Blood/Plasma Collection Device For Dna Testing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Medical specialty
- Clinical Chemistry
- FDA definition
- A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
- Adverse events (MAUDE)
- 2021: 14 · 2022: 16 · 2023: 63 · 2024: 168 · 2025: 264 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PAXgene® Blood DNA Tube (K231469) | Preanalytix GmbH | 2023-06-21 |
| PAXgene Blood DNA Tube (K142821) | Preanalytix GmbH | 2015-09-09 |
| VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (K042927) | Greiner Bio-One Vacuette North America | 2005-04-15 |
| S-MONOVETTE EDTA K2-GEL (K031359) | Sarstedt, Inc. | 2003-09-12 |
| VACUETTE EDTA K2 TUBES (K014104) | Greiner Vacuette North America, Inc. | 2002-02-01 |
| VACUETTE EDTA K2 GEL TUBES (K012043) | Greiner Vacuette North America, Inc. | 2001-09-24 |
| MULTIPLE (IZON DNA BLOOD COLLECTION KIT) (K010328) | Izon Business Products, Inc. | 2001-04-09 |
| VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (K972075) | Becton Dickinson Vacutainer Systems | 1998-02-24 |
Track PJE automatically
Every clearance here is in the API, with alerts when new ones post.