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Diazyme Glycated Serum Protein Enzymatic Assay Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042193

by Diazyme Laboratories

Identifiers

510(k) Number
K042193 FDA 510(k)
FDA Product Code
LCP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7470 FDA 510(k)
Regulation Number
864.7470 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Diazyme Glycated Serum Protein Enzymatic Assay Kit is an in vitro diagnostic device classified as an assay for measuring glycosylated hemoglobin and related glycated serum proteins. It quantifies glycated serum protein levels, serving as a biomarker for monitoring average blood glucose concentrations over a 2–3 week period, complementing traditional HbA1c assessments.

This enzymatic assay kit is intended for use in clinical laboratories and medical settings to evaluate glycemic control in patients. Supplied as a single-use reagent kit, it requires no sterilization beyond manufacturer-provided packaging. The device is FDA-cleared under 510(k) K042193, adhering to regulatory standards for hematology diagnostics (regulation number 864.7470). No MRI safety or reusable components are indicated in the specifications.

Frequently asked questions

What clinical purpose does the Diazyme Glycated Serum Protein Enzymatic Assay Kit serve in patient monitoring?

This assay kit measures glycosylated serum proteins, which act as biomarkers to evaluate average blood glucose levels over a 2–3 week period. It complements traditional HbA1c tests by providing additional insight into glycemic control for patients, particularly useful in clinical laboratories and medical settings.

Is the Diazyme Glycated Serum Protein Enzymatic Assay Kit designed for single-use or reusable applications?

The kit is explicitly supplied as a single-use reagent kit, meaning each package is intended for one-time use only. No sterilization beyond the manufacturer’s sealed packaging is required, ensuring safety and consistency for each test.

How is the regulatory pathway for this device classified, and what does that mean for its use?

The device is classified under FDA’s 510(k) pathway (K042193) as substantially equivalent to a predicate device, adhering to regulatory standards for hematology diagnostics (regulation 864.7470). This means it has undergone FDA review to confirm its safety and performance for measuring glycated serum proteins in clinical settings.

What type of laboratory or medical setting is this assay kit intended for, and why?

The kit is designed for use in clinical laboratories and medical settings where precise glycemic monitoring is required. Its enzymatic assay method is optimized for laboratory environments where standardized testing procedures are essential to ensure accurate measurement of glycated serum proteins as a biomarker.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Glycated Serum Protein - Diazyme Laboratories, PDF GLYCATED SERUM PROTEIN ASSAY - Diazyme, Glycated Serum Protein Enzymatic Test Kit | Diazyme Laboratories, Glycated Serum Protein Assay — Diazyme Laboratories, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diazyme Laboratories

Sources (1)

  • FDA 510(k) K042193 24 fields · synced Sep 20, 2026