# K040332: Polymedco Spotchem EZ Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Jun 16, 2004 after 127 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- 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 Polymedco SpotChem EX and ALT test system is an in vitrodiagnostic instrument and procedure intended to measure the activity of the enzyme alanine amino transferase or ALT (also know as a serum glutamic pyruvic transaminase or SGPT) in serum, plasma and whole blood. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Source page: https://510kreport.com/device/K040332
Methodology: https://510kreport.com/methodology