Alkaline Phosphatase Assay Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K842243 ↗

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 Diagnostic Chemicals, Ltd. (Usa) →

• What clinical conditions can this assay help evaluate when measuring alkaline phosphatase levels?

  This assay is designed to measure alkaline phosphatase (ALP) activity, which aids in evaluating liver, bone, parathyroid, or intestinal conditions. By quantifying ALP or its isoenzymes through absorbance at 405 nm, clinicians can assess potential abnormalities linked to these systems, such as bone metabolism disorders, liver disease, or parathyroid dysfunction.

• Is this kit reusable, or is it intended for single-use only?

  The kit is explicitly labeled as a single-use reagent system, meaning it cannot be reused or reprocessed after one use. This design ensures accuracy and safety in laboratory settings, as third-party reprocessing is not permitted.

• What type of biological samples can be tested with this assay, and does it require any sample pretreatment?

  The kit is intended for use with biological samples in clinical chemistry settings, but it does not require any sample pretreatment. This simplifies workflows by allowing direct measurement of ALP activity without additional preparation steps.

• How is this device regulated, and what does the FDA clearance classification mean for its use?

  The kit received FDA 510(k) clearance under the classification of Class II (CJE), meaning it is considered a moderate-risk device. This classification ensures it meets stringent regulatory standards for safety and effectiveness in measuring ALP activity, while also requiring compliance with specific manufacturing and labeling requirements.

• Are there any specific storage instructions provided for this assay kit?

  The regulatory data does not specify storage conditions for this kit, so it is important to refer to the manufacturer’s instructions for proper handling. Typically, such assays should be stored according to guidelines for reagent stability, such as refrigeration or room temperature, but exact details would be provided by Diagnostic Chemicals, Ltd.