# K020625: Spife 2000/3000 Alp 40, 20; Models 3345 and 3346

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: May 6, 2002 after 69 days
- Product code: CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- 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 test system will be used in laboratories to separate serum ALP into the bone, liver, intestine or macrohepatic isoenzymes. Elevated bone isoenzyme can be found in conditions of physiologic bone growth, osteoporosis and nutritional deficiency such as rickets. Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver. Intestinal isoenzymes can be seen in patients with intestinal disease and in individuals of blood type O or B after a meal.

Source page: https://510kreport.com/device/K020625
Methodology: https://510kreport.com/methodology