# K042927: Vacuette Edta K3 Evacuated Blood Collection Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One Vacuette North America
- Decided: Apr 15, 2005 after 175 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: 2 generations back to K945952 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972075: Vacutainer Brand PPT Plasma Preparation Tube, Becton Dickinson Vacutainer Systems (1998) Summary page 1.
- (no number) Glass K, EDTA Tube (pre-amendment): named in the summary without a submission number

## Indications for use
VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® EDTA K3 Tubes are used for testing plasma in molecular diagnostics. 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/K042927
Methodology: https://510kreport.com/methodology