# K050790: Spotchem II LDH Test

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Jun 6, 2005 after 70 days
- Product code: CFH (Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase)
- Device class: 2
- Regulation: 21 CFR 862.1440
- 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 no predicate by number.

## Indications for use
The SPOTCHEM II LDH test is intended to measure the activity of the enzyme lactate dehydrogenase in serum, plasma, and whole blood. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

Source page: https://510kreport.com/device/K050790
Methodology: https://510kreport.com/methodology