# K014104: Vacuette Edta K2 Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Vacuette North America, Inc.
- Decided: Feb 1, 2002 after 50 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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). Our OCR of the scanned summary read K572075, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube”.

## Most influential descendants
- K063357: Minicollect Capillary Blood Collection Tubes (2007), 0 descendants of its own

## Indications for use
The VACUETTE® EDTA K2 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. The VACUETTE® EDTA K2 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/K014104
Methodology: https://510kreport.com/methodology