# K063357: Minicollect Capillary Blood Collection Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One North America, Inc.
- Decided: Jul 10, 2007 after 245 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014104: Vacuette Edta K2 Tubes, Greiner Vacuette North America, Inc. (2002) Summary page 1.
- K940905: Microtainer Brand Tube with Edta (K2), Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

## Indications for use
Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes are designed for the collection, transportation and processing of capillary blood (collected via lancet stick) whenever a small amount of blood is preferred. Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are used to obtain whole blood for testing parameters in hematology.

Source page: https://510kreport.com/device/K063357
Methodology: https://510kreport.com/methodology