# K231469: PAXgene® Blood DNA Tube

- Pathway: 510(k) (Special)
- Applicant: Preanalytix GmbH
- Decided: Jun 21, 2023 after 30 days
- Product code: PJE (Blood/Plasma Collection Device For Dna Testing)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945952 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142821: PAXgene Blood DNA Tube, Preanalytix GmbH (2015) Summary page 4.

## Indications for use
The PAXgene® Blood DNA Tube is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.

Source page: https://510kreport.com/device/K231469
Methodology: https://510kreport.com/methodology