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Glucose HK New Formulation Test System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062239

by Roche Diagnostics Corp.

Identifiers

510(k) Number
K062239 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 HK New Formulation Test System is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

This test system is supplied for in vitro use in measuring glucose in human serum, plasma, urine, and CSF on Roche/Hitachi cobas c systems. The device is authorized under FDA 510(k) clearance with K number K062239 and is classified as a Class II device in clinical chemistry.

Frequently asked questions

What is the Glucose HK New Formulation Test System used for?

The Glucose HK New Formulation Test System is designed to quantitatively measure glucose in blood and other body fluids. These measurements are used in diagnosing and treating carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

In which body fluids can this test system measure glucose?

This test system is specifically formulated for in vitro measurement of glucose in human serum, plasma, urine, and cerebrospinal fluid (CSF) when used with Roche/Hitachi cobas c systems. It is not intended for direct measurement in whole blood.

What is the regulatory status of the Glucose HK Test System?

The device is authorized under FDA 510(k) clearance with K number K062239 and is classified as a Class II device in clinical chemistry. It received FDA clearance on September 11, 2006, after being determined substantially equivalent to predicate devices.

How is the Glucose HK Test System supplied?

The test system is supplied as a complete in vitro diagnostic solution for use on Roche/Hitachi cobas c systems. It includes all necessary components for quantitative glucose measurement in the specified body fluids, though specific packaging details aren't provided in the available information.

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 HK NEW FORMULATION TEST SYSTEM - Innolitics, K062239 FDA 510(k) - GLUCOSE HK NEW FORMULATION TEST SYSTEM, GLUC3, Glucose HK Gen.3 - Roche Diagnostics USA, PDF 510(k) Summary - COBAS INTEGRA Glucose HK Gen. 3

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA 510(k) K062239 24 fields · synced Sep 22, 2026