# K041427: The Polymedco Spotchem EX Glucose, Fructosamine and Ast Tests

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Nov 24, 2004 after 180 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (1 Class I)
- 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.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- Dec 18, 2015 · Class I · Z-0630-2016: One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected l

## Indications for use
The SpotChem EZ Glucose test system is an in vitro diagnostic procedure intended to measure glucose quantitatively in human serum and plasma on the SpotChem EZ analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic isle cell carcinoma. The SpotChem EZ Fructosamine test system is an in vitro diagnostic procedure intended to measure fructosamine quantitatively in human serum and plasma on the SpotChem EZ analyzer. Fructosamine measurements are used to assess the level of control of a patient’s diabetes and to determine the proper insulin dosage for a patient. Elevated levels of fructosamine indicate uncontrolled diabetes in a patient. The SpotChem EZ AST test system is an in vitro diagnostic procedure intended to measure AST quantitatively in human serum and plasma on the SpotChem EZ analyzer. AST mesurements are used in the diagnosis and treatment of certain liver and heart diseases.

Source page: https://510kreport.com/device/K041427
Methodology: https://510kreport.com/methodology