# K891407: Leucoprep Cell Separation Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: May 26, 1989 after 73 days
- Product code: JCF (Lymphocyte Separation Medium)
- Device class: 1
- Regulation: 21 CFR 864.8500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 3, 2014 · Class II · Z-2542-2014: BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.

Source page: https://510kreport.com/device/K891407
Methodology: https://510kreport.com/methodology