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Alkaline Phosphatase Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K923507

by Randox Laboratories, Ltd.

Identifiers

510(k) Number
K923507 FDA 510(k)
FDA Product Code
CJE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1050 FDA 510(k)
Regulation Number
862.1050 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Alkaline Phosphatase Kit is an in vitro diagnostic reagent designed for the quantitative determination of alkaline phosphatase (ALP) activity in serum or plasma. Alkaline phosphatase is an enzyme used clinically to assess liver function, bone metabolism, and certain metabolic bone diseases. This kit enables laboratories to measure ALP levels, aiding in the diagnosis and monitoring of conditions such as biliary obstruction, Paget’s disease, and bone disorders.

This kit is intended for use on automated, semi-automated, and manual biochemistry analysers, providing liquid ready-to-use reagents for clinical laboratories. Supplied as a single-use reagent, it requires no additional preparation beyond standard laboratory procedures. The device is classified as a Class 2 Chemistry device under FDA product code CJE and holds a 510(k) clearance (K923507) for substantial equivalence. No regulatory status beyond the stated FDA clearance is implied.

Frequently asked questions

What clinical conditions can the Alkaline Phosphatase Kit help diagnose or monitor?

This kit quantifies alkaline phosphatase (ALP) activity, aiding in the evaluation of liver function (e.g., biliary obstruction), bone metabolism (e.g., Paget’s disease), and metabolic bone disorders. Elevated or abnormal ALP levels can indicate these conditions, making the test critical for diagnostic and monitoring purposes in clinical chemistry.

How is the Alkaline Phosphatase Kit supplied, and what preparation is required?

The kit is supplied as liquid, ready-to-use reagents designed for immediate use on automated, semi-automated, or manual biochemistry analysers. No additional preparation beyond standard laboratory procedures is needed, ensuring convenience for clinical workflows.

Is the Alkaline Phosphatase Kit single-use or reusable, and what are its sterility specifications?

The kit is intended for single-use only, as specified for in vitro diagnostic reagents. Sterility is maintained through standard manufacturing practices for liquid reagents, ensuring reliability for one-time clinical analysis without cross-contamination risks.

Which analysers are compatible with the Alkaline Phosphatase Kit?

The kit is compatible with a wide range of automated, semi-automated, and manual biochemistry analysers commonly used in clinical laboratories. Compatibility is ensured by its liquid, ready-to-use formulation, which aligns with standard analyser protocols for quantitative enzyme assays.

How should the Alkaline Phosphatase Kit be stored, and what are the key considerations?

Storage instructions follow standard laboratory practices for liquid diagnostic reagents: protect from light, maintain at 2–8°C (refrigerated), and avoid freezing. Proper storage preserves reagent integrity and accuracy, ensuring reliable ALP measurements when used within the manufacturer’s specified expiration date.

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: Alkaline Phosphatase - Randox Laboratories, Alkaline Phosphatase | Biochemistry | Reagents | Randox Laboratories, Alkaline Phosphatase assay - Randox Online Store, Alkaline Phosphatase assay - Randox Online Store, K923507 - ALKALINE PHOSPHATASE KIT | 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) K923507 24 fields · synced Oct 1, 2026