Alkaline Phosphatase Reagent Set

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

510(k) Number

K843332 ↗

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 Sterling Biochemical, Inc. →

• What is the Alkaline Phosphatase Reagent Set used for?

  The Alkaline Phosphatase Reagent Set is an in vitro diagnostic device designed to measure alkaline phosphatase enzyme levels or its isoenzymes in serum or plasma samples. Elevated alkaline phosphatase levels can indicate conditions affecting the liver, bones, parathyroid gland, or intestines, making it useful for diagnostic purposes and treatment monitoring in clinical settings.

• Is the Alkaline Phosphatase Reagent Set intended for single-use or reuse?

  This reagent set is explicitly supplied as a single-use diagnostic tool. It is not designed for reuse, ensuring accuracy and sterility for each measurement in clinical chemistry laboratories.

• What regulatory approval does the Alkaline Phosphatase Reagent Set hold?

  The device has received FDA 510(k) clearance under the classification of Class II (CJE) and is regulated under 21 CFR 862.1050. This clearance confirms its substantial equivalence to a predicate device and ensures compliance with U.S. regulatory standards for in vitro diagnostics.

• Can the Alkaline Phosphatase Reagent Set be used in an MRI environment?

  No, the device is explicitly noted as not MRI-safe. This means it should not be used or stored in proximity to MRI machines, as exposure to magnetic fields could compromise its integrity or performance.

• What storage conditions should be followed for the Alkaline Phosphatase Reagent Set?

  The available data does not specify storage conditions for this reagent set. Laboratories should follow the manufacturer’s instructions (provided in the packaging or documentation) for optimal storage to maintain the device’s stability and performance. If no guidance is provided, standard laboratory practices for single-use diagnostic reagents should be applied.