HiChem Glucose/HK Reagent Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K960084 ↗

FDA Product Code

CFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Astra-T Calcium Reagent

  Class II

  FDA 510(k) K820090 Active Cleared 28 Jan 1982

• Cholar Produ&T #17010

  Class I

  FDA 510(k) K771731 Active Cleared 25 Oct 1977

• Direct Bilirubin Reagent

  Class II

  FDA 510(k) K841572 Active Cleared 16 May 1984

• Cholorde Reagent

  Class II

  FDA 510(k) K791690 Active Cleared 17 Sep 1979

• Hilar

  Class II

  FDA 510(k) K782094 Active Cleared 17 Jan 1979

• Ast Reagent Cartridge

  Class II

  FDA 510(k) K861283 Active Cleared 28 Apr 1986

See all devices from Hi Chem, Inc. →

• What biological samples can the HiChem Glucose/HK Reagent Kit measure glucose in?

  The HiChem Glucose/HK Reagent Kit is designed for quantitative glucose determination in serum, plasma, cerebrospinal fluid (CSF), and urine. This versatility makes it suitable for a range of clinical chemistry applications, including diabetes management, metabolic monitoring, and neurological diagnostics where glucose levels in non-blood samples may be relevant.

• Is the HiChem Glucose/HK Reagent Kit intended for single-use or reusable applications?

  The HiChem Glucose/HK Reagent Kit is explicitly supplied as a single-use reagent system for laboratory use. This design ensures consistency in measurement accuracy and reduces the risk of cross-contamination or degradation of reagents between uses, which is critical for reliable glucose testing in clinical settings.

• How is the enzymatic hexokinase method in this kit different from other glucose testing methods?

  The HiChem Glucose/HK Reagent Kit employs an enzymatic hexokinase method, where glucose reacts with hexokinase and ATP to produce glucose-6-phosphate. This biochemical reaction is highly specific to glucose and minimizes interference from other sugars (e.g., galactose or fructose), providing more accurate results compared to methods like glucose oxidase, which may be affected by certain antioxidants or uric acid. This precision is particularly valuable in clinical chemistry for diagnosing and managing conditions like diabetes.

• What regulatory pathway does the HiChem Glucose/HK Reagent Kit follow, and what does that mean for users?

  The HiChem Glucose/HK Reagent Kit is regulated under the FDA 510(k) pathway (K960084) as a Class 2 device under product code CFR 862.1345. This classification means it has undergone FDA review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets established performance standards for safety and effectiveness. Users can rely on this regulatory clearance as evidence of the kit’s compliance with U.S. clinical chemistry standards.

• Are there any special storage requirements for the HiChem Glucose/HK Reagent Kit beyond standard laboratory protocols?

  While the provided specifications do not detail specific storage instructions beyond standard laboratory reagent protocols, it is generally recommended to store enzymatic reagent kits like this one in a cool, dry place (2–8°C) away from direct light to preserve reagent stability. Exposure to extreme temperatures, humidity, or light can degrade enzymes (e.g., hexokinase) and compromise accuracy. Always follow the manufacturer’s accompanying documentation or contact HiChem, Inc. for precise handling guidance.