# K162723: TransFix/EDTA Vacuum Blood Collection Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Caltag Medsystems, Ltd.
- Decided: Jun 22, 2017 after 266 days
- Product code: GIM (Tubes, Vacuum Sample, With Anticoagulant)
- 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 K030596 (2003). 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)
- K080552: Cyto-Chex BCT, Streck (2008) Summary page 4.

## Indications for use
TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of white blood cells by flow cytometry. Recovery of lymphocyte subset markers of the HIV panel can be accomplished over a 14-day period following collection. TVTs are in-vitro diagnostic medical devices.

Source page: https://510kreport.com/device/K162723
Methodology: https://510kreport.com/methodology