# K133803: Diazyme Glycated Serum Protein Poc Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Aug 6, 2014 after 233 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 K110188 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110188: Diazyme Glycated Serum Protein Assay / Calibrator Kit / Control Kit, Diazyme Laboratories (2011) Summary page 5.

## Indications for use
The Diazyme Glycated Serum Protein POC Test Kit is intended for the quantitative determination of glycated serum proteins (GSP; fructosamine) in serum. Fructosamine is representative of blood glucose levels over the course of 2-3 weeks. The measurement of glycated serum proteins is useful for monitoring diabetic patients. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K133803
Methodology: https://510kreport.com/methodology