# K030815: Akers Laboratories Inc. Blood Cell Separator

- Pathway: 510(k) (Traditional)
- Applicant: Akers Laboratories, Inc.
- Decided: Sep 17, 2003 after 187 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.
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. The FDA summary names its predicate without a number.
- (no number) Vacutainer Brand Tube for the Determinations Requiring Serum: named in the summary without a submission number
- (no number) Vacutainer Brand Tube for Hematology and Selective Chemistry Determination: named in the summary without a submission number

## Indications for use
The Blood Cell Separator is intended for the use as a sample preparation aid to in vitro Lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen. The liquid produced by the device is dependent upon the sample collected; whole blood collected with an anti-coagulant will produce plasma, and whole blood collected without an anti- coagulant will produce serum.

Source page: https://510kreport.com/device/K030815
Methodology: https://510kreport.com/methodology