Olympus Lactate Dehydrogenase Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K923412 ↗

FDA Product Code

CFJ

Device Class

Class II

Regulation

21 CFR Part 862.1440

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

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  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

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  FDA 510(k) K904940 Active Cleared 13 Jan 1992

See all devices from Olympus Corp. →

• What clinical conditions can the Olympus Lactate Dehydrogenase Reagent help diagnose or monitor using LDH enzyme levels?

  The Olympus Lactate Dehydrogenase Reagent is designed to measure lactate dehydrogenase (LDH) activity in human serum and plasma, which aids in diagnosing and monitoring conditions affecting cellular metabolism. Elevated or abnormal LDH levels can indicate tissue damage, disease progression, or metabolic disorders, such as those involving the heart, liver, muscles, or blood cells. It is particularly useful in clinical chemistry for assessing conditions like myocardial infarction, hemolytic anemia, liver disease, or muscle injury.

• How is the Olympus Lactate Dehydrogenase Reagent supplied, and what are the available packaging configurations?

  The reagent is supplied in liquid form and comes in specific packaging configurations, including combinations like 4×40 mL + 4×20 mL. This format ensures compatibility with Olympus AU series biochemical analyzers, which are designed for in vitro diagnostic use. The packaging maintains stability for accurate LDH activity measurements.

• Is the Olympus Lactate Dehydrogenase Reagent intended for single-use or can it be reused?

  The reagent is intended for in vitro diagnostic use and is supplied in liquid form for direct incorporation into biochemical assays. While the exact reuse policy isn’t explicitly stated, typical in vitro diagnostic reagents like this are designed for single-use per batch to ensure accuracy and prevent contamination. Always follow manufacturer guidelines for optimal performance.

• What storage conditions must be followed to maintain the reagent’s stability and accuracy?

  The reagent requires protection from light and temperature fluctuations to preserve its stability and ensure accurate LDH measurements. Standard in vitro diagnostic reagent protocols should be followed, which typically include storing it at the recommended temperature (often 2–8°C) and avoiding exposure to direct sunlight or extreme heat. Always check the label for specific storage instructions.

• What regulatory pathway was followed for FDA clearance of the Olympus Lactate Dehydrogenase Reagent?

  The Olympus Lactate Dehydrogenase Reagent was cleared through the FDA 510(k) pathway, specifically under Traditional Review, and classified as a Class II device. The submission was reviewed by the Clinical Chemistry (CH) Advisory Committee, with a decision of Substantially Equivalent (SESE). Clearance numbers include K923412 and K924965, reflecting its regulatory status as a diagnostic reagent for biochemical assays.