# K042193: Diazyme Glycated Serum Protein Enzymatic Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Oct 29, 2004 after 78 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
Longest line of descent: 1 generation back to K023763 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023763: Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls, Randox Laboratories, Ltd. (2003) Summary page 1.

## Most influential descendants
- K131307: Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine Calibrator (2014), 0 descendants of its own

## Indications for use
Diazyme Glycated Serum Protein Enzymatic Assay Kit in conjunction with Diazyme Glycated Serum Protein single calibrator, are intended for the quantitative determination of glycated serum proteins (fructosamine) in serum. The measurement of glycated serum proteins (fructosamine) is useful for monitoring diabetic patients. Diazyme Glycated Serum Protein Enzymatic Assay Kit contains a single calibrator. The calibrator is used in the calculation of glycated serum protein concentrations in unknown serum samples. Diazyme Glycated Serum Protein Enzymatic Assay has controls for normal glycated serum protein level and abnormal glycated serum protein level. The controls are used as reference samples for checking the functionality of the Diazyme Glycated Serum Protein Enzymatic Assay.

Source page: https://510kreport.com/device/K042193
Methodology: https://510kreport.com/methodology