Olympus Alkaline Phosphatase Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K925156 ↗

FDA Product Code

CJE

Device Class

Class II

Regulation

21 CFR Part 862.1050

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Olympus Direct Bilirubin Reagent

  Class II

  FDA 510(k) K924963 Active Cleared 30 Nov 1992

• Olympus Chloride Reagent, Modification

  Class II

  FDA 510(k) K934136 Active Cleared 5 Nov 1993

• Resectoscope Sheath

  Class II

  FDA 510(k) K931994 Active Cleared 17 Feb 1994

• Olympus Measuring Devices

  Class II

  FDA 510(k) K933717 Active Cleared 2 Nov 1993

• Sterile Disposable Cytology Brush

  Not classified

  FDA 510(k) K802187 Active Cleared 10 Sep 1980

• Olympus Infant Resectoscope and Accessories

  Class II

  FDA 510(k) K904940 Active Cleared 13 Jan 1992

See all devices from Olympus Corp. →

• What clinical conditions is this reagent primarily used to evaluate, and why is it important in diagnostic testing?

  The Olympus Alkaline Phosphatase Reagent is primarily used to measure alkaline phosphatase or its isoenzymes in serum or plasma, which helps evaluate liver function, bone metabolism, parathyroid activity, and intestinal health. It is essential for diagnosing and monitoring conditions like liver disease, bone disorders (such as Paget’s disease or rickets), hyperparathyroidism, and certain gastrointestinal issues. Elevated or abnormal levels of alkaline phosphatase can signal underlying pathology, making this reagent critical for accurate clinical assessment.

• Is this reagent intended for single-use only, and if so, why does that matter in a clinical lab setting?

  Yes, the Olympus Alkaline Phosphatase Reagent is explicitly supplied for single-use applications. This matters in a clinical lab setting because single-use reagents minimize the risk of cross-contamination between patients, reduce the need for sterilization between uses, and help maintain consistent test accuracy. Reusing reagents could introduce variability or contamination, potentially compromising diagnostic reliability.

• How is this reagent supplied, and what should clinicians or lab technicians consider when handling it?

  The reagent is supplied as a liquid for use in clinical chemistry laboratories. Since it is a diagnostic reagent, clinicians and lab technicians should handle it in a controlled environment, following standard laboratory protocols for reagent storage and use. Proper labeling, temperature control (if applicable), and adherence to manufacturer guidelines for preparation and disposal are critical to ensure accurate test results and compliance with safety standards.

• What regulatory pathway was used for its clearance, and what does that mean for its intended use?

  The Olympus Alkaline Phosphatase Reagent was cleared through the FDA’s 510(k) Traditional pathway, determined to be Substantially Equivalent (SESE) to a predicate device. This means the FDA reviewed it against an existing, legally marketed device and concluded it has the same intended purpose and technological characteristics. Clinically, this confirms its suitability for in vitro diagnostic use—specifically, measuring alkaline phosphatase or its isoenzymes in serum or plasma—as described in the product’s labeling.