# K013466: Spife 2000/3000 Lipoprotein; Model# 3340, 3341, 3342, 3343

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Dec 21, 2001 after 64 days
- Product code: JHO (Electrophoretic Separation, Lipoproteins)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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 SPIFE 2000/3000 Lipoprotein System is useful in the prevention and detection of coronary heart disease. Increased dietary fats and lipids are linked to atherosclerosis which leads to cardiovascular disease and strokes.

Source page: https://510kreport.com/device/K013466
Methodology: https://510kreport.com/methodology