# K020467: Spife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Mar 29, 2002 after 45 days
- Product code: CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1445
- 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 LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause. The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion. Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.

Source page: https://510kreport.com/device/K020467
Methodology: https://510kreport.com/methodology