# K030596: Immunicon Cellsave Preservative Tube

- Pathway: 510(k) (Traditional)
- Applicant: Immunicon Corp.
- Decided: Aug 8, 2003 after 164 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Vacutainer Brand Blood Collection Tube with EDTA Anticoagulant: named in the summary without a submission number

## Most influential descendants
- K040107: Cyto-Chex BCT (2004), 2 descendants of its own
- K080552: Cyto-Chex BCT (2008), 1 descendant of its own
- K162723: TransFix/EDTA Vacuum Blood Collection Tubes (2017), 0 descendants of its own

## Indications for use
CellSave tubes are evacuated blood collection tubes that are designed to be used with standard phlebotomy supplies for venous blood collections. The tube contains 300 μl of a solution that contains Na2EDTA and a cell preservative. The preservative preserves morphology and cell surface antigen expression of the epithelial cells and leukocytes. This tube may be used for monitoring of circulating epithelial cells (tumor cells) which may aid in the management of cancer patients. This tube may be used for monitoring CD3+/CD4+ T lymphocyte subsets which may aid in the management of patients with HIV/AIDS.

Source page: https://510kreport.com/device/K030596
Methodology: https://510kreport.com/methodology