Colorimetric Determination (LDH) K760009

No FDA recalls on record, checked 22 Oct 2026.

Full name

Colorimetric Determination (Ldh)

510(k) Number

K760009 ↗

FDA Product Code

CFH

Device Class

Class II

Regulation

21 CFR Part 862.1440

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Cholesterol Reagent Set

  Class I

  FDA 510(k) K770998 Active Cleared 2 Jun 1977

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  FDA 510(k) K800550 Active Cleared 2 Apr 1980

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  Class II

  FDA 510(k) K770940 Active Cleared 22 Jun 1977

• Accessory Hdl Cholesterol Reagent Set

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  FDA 510(k) K780638 Active Cleared 26 May 1978

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  FDA 510(k) K781020 Active Cleared 27 Jul 1978

• Clinical Spectrophotometer

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  FDA 510(k) K760672 Active Cleared 29 Oct 1976

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• What clinical conditions is this LDH assay used to evaluate?

  This colorimetric LDH assay quantifies lactate dehydrogenase activity in biological samples to assess tissue damage, organ function (e.g., liver, heart), and metabolic disorders. LDH levels rise when cells are injured or dying, making it a key diagnostic marker for conditions like myocardial infarction, hepatitis, or hemolytic anemia. The tetrazolium dye reduction method provides a proportional color change for precise enzyme activity measurement.

• How is the Colorimetric Determination (LDH) K760009 supplied, and what are its key components?

  The kit is supplied as a reagent system for in vitro diagnostic use in clinical chemistry laboratories. It includes all necessary chemicals for the tetrazolium dye-based assay, including substrates and buffers, but does not require additional hardware beyond standard lab equipment. The single-use format ensures consistency and eliminates cross-contamination risks, aligning with typical clinical chemistry workflows.

• Is sterility or decontamination required for this assay kit?

  The submission data does not specify sterility requirements or decontamination protocols for this reagent kit. Since it is intended for single-use in controlled laboratory environments, standard aseptic techniques during sample handling and assay execution should be followed. There are no indications that the kit itself is sterile or requires terminal sterilization.

• What regulatory pathway does this device follow, and what does that mean for users?

  This assay received FDA 510(k) clearance under the Traditional pathway (K760009), classified as a Class II medical device (Regulation 862.1440). The clearance was granted in 1976 based on substantial equivalence to a predicate device, meaning it meets established performance standards for clinical chemistry assays. Users can rely on this designation for compliance with U.S. regulatory requirements, though local laboratory protocols must still adhere to CLIA or equivalent standards.

• Can this kit be reused, or does it require disposal after one use?

  The kit is explicitly designed for single-use only. Reusing components could compromise accuracy due to reagent degradation, cross-contamination, or inconsistent colorimetric readings. Each kit is intended for one assay cycle, aligning with best practices for diagnostic reagents to ensure reliable LDH measurement and patient safety.