Glucose (Hexokinase) Delta Test Assay

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K770262 ↗

FDA Product Code

CFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Glucose (Hexokinase) Delta Test Assay used for?

  This assay is designed for in vitro diagnostic use to quantify glucose levels in blood and other body fluids. It employs enzymatic hexokinase methods to help clinicians assess carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. The results aid in diagnosing and monitoring these conditions by providing accurate glucose measurements.

• How is the Glucose (Hexokinase) Delta Test Assay supplied, and is it single-use?

  The assay is supplied as a reagent kit intended for use in clinical chemistry laboratories. It is explicitly designed for single-use applications, meaning each kit is meant to be used once before disposal. This ensures consistency and reliability in test results while minimizing the risk of contamination.

• Are there any special storage requirements for this assay kit?

  The kit does not require special storage conditions beyond those outlined in the accompanying instructions. Standard laboratory storage practices, such as protecting it from extreme temperatures and light, should be followed to maintain its integrity and performance. Always refer to the included documentation for precise storage guidelines.

• What regulatory clearance does the Glucose (Hexokinase) Delta Test Assay hold?

  This assay holds an FDA 510(k) clearance under the classification of Clinical Chemistry, with a decision date of February 23, 1977. It is regulated under CFR 862.1345 and is classified as substantially equivalent to a predicate device. The clearance indicates that it meets the regulatory standards for use in clinical settings as described in the provided data.

• Can this assay be used for measuring glucose in fluids other than blood?

  Yes, the Glucose (Hexokinase) Delta Test Assay is intended for quantifying glucose levels not only in blood but also in other body fluids. This versatility allows clinicians to assess glucose metabolism across various samples, supporting broader diagnostic evaluations for metabolic disorders and related conditions.