# K050652: Spotchem II Creatinine, Amylase & Alp Tests

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Apr 6, 2005 after 23 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- 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 SPOTCHEM II Creatinine test is intended to measure the concentration of creatinine in serum, plasma, and whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The SPOTCHEM II Amylase test is intended to measure amylase activity in serum, plasma, and whole blood. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The SPOTCHEM II ALP test is intended to measure ALP activity in serum, plasma, and whole blood. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Source page: https://510kreport.com/device/K050652
Methodology: https://510kreport.com/methodology