Alkaline Phosphatase Liquid Reagent

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

510(k) Number

K011599 ↗

FDA Product Code

CJE

Device Class

Class II

Regulation

21 CFR Part 862.1050

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Jas Diagnostic, Inc. →

• What clinical applications is this reagent primarily used for in a lab setting?

  This reagent is designed for quantitative measurement of alkaline phosphatase activity in human serum, which is critical for assessing liver function, bone metabolism, and other physiological processes. Elevated or abnormal levels can indicate conditions like liver disease, bone disorders, or metabolic bone diseases, making it a key tool in clinical chemistry for diagnostic evaluation.

• How is the Alkaline Phosphatase Liquid Reagent supplied, and what type of analyzers can it be used with?

  The reagent is supplied as a liquid and is intended exclusively for use on automated chemistry analyzers within clinical laboratory settings. It reacts with serum samples to produce measurable changes proportional to alkaline phosphatase levels, ensuring compatibility with automated systems for high-throughput biochemical analysis.

• Is there any information provided about the sterility or single-use/reuse status of this reagent?

  The provided data does not specify whether the reagent is sterile or if it is intended for single-use or reuse. Clinicians should refer to the manufacturer’s instructions for proper handling, storage, and usage guidelines to ensure safety and accuracy in testing.

• What regulatory pathway was followed for this device’s clearance, and what does that imply for its use?

  The reagent holds an FDA 510(k) clearance (K011599) under the substantial equivalence pathway, meaning it was determined to be as safe and effective as a legally marketed predicate device. This clearance falls under the classification of Class II medical devices, which are subject to special controls for clinical chemistry reagents, ensuring its suitability for use in clinical laboratories for alkaline phosphatase testing.