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Glucose (Hexokinase) Kit K953210

FDA 510(k)

Class II (US FDA 510(k))

510(k) K953210

by Randox Laboratories, Ltd.

Identifiers

510(k) Number
K953210 FDA 510(k)
FDA Product Code
CFR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1345 FDA 510(k)
Regulation Number
862.1345 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Glucose (Hexokinase) Kit K953210 is a diagnostic in vitro device classified as a hexokinase glucose test system. It is designed to measure glucose levels quantitatively in blood and other body fluids using the hexokinase enzymatic method. This kit facilitates accurate biochemical analysis for clinical chemistry applications, supporting diagnostic and monitoring processes.

This kit is supplied as liquid and lyophilized reagents, requiring storage at 2–8°C to maintain stability until expiry. It is intended for single-use in clinical laboratory settings and has received FDA 510(k) clearance under the Clinical Chemistry advisory committee. The device adheres to regulatory requirements outlined under CFR 862.1345 and is classified as a Class II medical device.

Frequently asked questions

What is the Glucose (Hexokinase) Kit K953210 used for?

The Glucose (Hexokinase) Kit K953210 is designed for quantitative measurement of glucose levels in blood and other body fluids. It employs the hexokinase enzymatic method, which provides accurate biochemical analysis critical for clinical chemistry applications. This ensures reliable diagnostic and monitoring support for conditions requiring precise glucose assessment, such as diabetes management.

How is the Glucose (Hexokinase) Kit K953210 supplied, and what are its storage requirements?

The kit is supplied as a combination of liquid and lyophilized reagents. To maintain stability and ensure accurate results, it must be stored at temperatures between 2–8°C. Proper storage is essential to preserve the reagents’ integrity until the product’s expiry date, preventing degradation that could compromise test accuracy.

Is the Glucose (Hexokinase) Kit K953210 intended for single-use or reusable applications?

This kit is explicitly designed for single-use in clinical laboratory settings. Single-use ensures patient safety by eliminating cross-contamination risks and maintains consistency in test results. Reuse is not recommended, as it could compromise sterility and accuracy, potentially leading to unreliable diagnostic outcomes.

What regulatory pathway does the Glucose (Hexokinase) Kit K953210 follow?

The kit has received FDA 510(k) clearance under the Clinical Chemistry advisory committee, classifying it as a Class II medical device. This clearance confirms that it meets regulatory requirements outlined under CFR 862.1345, ensuring compliance with safety and performance standards for in vitro diagnostic devices in the United States.

Are there different models or sizes available for the Glucose (Hexokinase) Kit?

The provided data specifies the model reference as K953210, indicating this is a singular kit configuration. No variations in sizes or additional models are mentioned in the documentation. For specific batch or lot-related inquiries, consulting the manufacturer’s technical documentation or support team is recommended to confirm any potential variations or updates.

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: Glucose | Reagent | Randox Laboratories, GLUCOSE (HEXOKINASE) KIT (K953210) — FDA 510 (k) | Innolitics, GLUCOSE (HEXOKINASE) KIT by RANDOX LABORATORIES, LTD. | FDA 510 (k) Summary, GLUCOSE (HEXOKINASE) KIT (K953210) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA 510(k) K953210 24 fields · synced Oct 1, 2026