# K030394: Fluid Sample Retrieval System

- Pathway: 510(k) (Traditional)
- Applicant: Biomed Personal Metabolic and Nutritional Testing
- Decided: Oct 27, 2003 after 264 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Personal Fluid Sample Retrieval System is for use for over-the-counter distribution and is a device for collection and transportation of serum for in vitro diagnostic quantitative determination of cholesterol, triglycerides, glucose, HDL cholesterol and calculated LDL cholesterol. The serum sample is transferred in a transport pouch to the testing laboratory and results are returned directly to the consumer.

Source page: https://510kreport.com/device/K030394
Methodology: https://510kreport.com/methodology