# K023654: Glyca-Direct Fructosamine

- Pathway: 510(k) (Traditional)
- Applicant: Polymedco, Inc.
- Decided: May 2, 2003 after 184 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- 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 Glyca-Directm Fructosamine Test is used for the quantitative determination of glycated proteins in serum and plasma. The Polymedco Glyca-Direct" Fructosamine Test is use for the quantitative determination of glycated proteins in serum and plasma. The measurement of glycated serum proteins (Fructosamine) is useful for monitoring long-term control of diabetes. This application was developed for the Polymedco Poly-Chem analyzer.

Source page: https://510kreport.com/device/K023654
Methodology: https://510kreport.com/methodology