# K012043: Vacuette Edta K2 Gel Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Vacuette North America, Inc.
- Decided: Sep 24, 2001 after 87 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.

## Indications for use
The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material. The VACUETTE® EDTA K2 Gel tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR — Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.

Source page: https://510kreport.com/device/K012043
Methodology: https://510kreport.com/methodology