# K110188: Diazyme Glycated Serum Protein Assay / Calibrator Kit / Control Kit

- Pathway: 510(k) (Special)
- Applicant: Diazyme Laboratories
- Decided: May 17, 2011 after 113 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K133803: Diazyme Glycated Serum Protein Poc Test Kit (2014), 0 descendants of its own

## Indications for use
Diazyme Glycated Serum Protein Assay Kit in conjunction with Diazyme Glycated Serum Protein single calibrator is intended for the quantitative determination of glycated serum proteins (GSP; glycated albumins; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients. Diazyme Glycated Serum Protein Assay is used with a single calibrator. The calibrator is used in the calculation of glycated serum protein concentrations in unknown serum samples. Diazyme Glycated Serum Protein 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/K110188
Methodology: https://510kreport.com/methodology