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    K Number
    K981794
    Device Name
    HICHEM CALCIUM REAGENT KIT
    Manufacturer
    HICHEM DIAGNOSTICS
    Date Cleared
    1998-07-29

    (69 days)

    Product Code
    CJY
    Regulation Number
    862.1145
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HICHEM CALCIUM REAGENT KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HiChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

    Device Description

    The HiChem Calcium Reagent determines calcium by its reaction with arsenazo III to form a blue complex. The resulting increase in absorbance at 650 nm is proportional to the calcium concentration in the sample. The HiChern Calcium Reagent is an adaptation of the arsenazo III calcium method, first reported by Michaylova and Illikova and is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the HiChem Calcium Reagent, based on the provided text:

    Acceptance Criteria and Device Performance

    The provided text describes two main scenarios for the HiChem Calcium Reagent: the manual procedure and its use on the Beckman® SYNCHRON CX® Systems (secondary reagent application). The acceptance criteria are largely implied by the reported performance, as the study aims to demonstrate substantial equivalence to an existing predicate device.

    Table of Acceptance Criteria and Reported Device Performance

    Performance MeasureAcceptance Criteria (Implied)HiChem Calcium Reagent (Manual Procedure) Reported PerformanceHiChem Calcium Reagent (SYNCHRON CX® Systems) Reported Performance
    LinearityDemonstrate linearity over a specific range.Linear between 0.1 to 16 mg/dL. Regression: (HiChem) = -0.1 + 0.980 x (Standard Conc.), r² = 1.000, sy.x = 0.14 mg/dL.Linear from at least 2.0 mg/dL to 15.0 mg/dL. Regression: (HiChem) = 0.0 + 0.967 x (Standard Conc.), r² = 1.000, sy.x = 0.08 mg/dL.
    PrecisionMeet specified SD for various control levels.Serum Control 1 (6.69 mg/dL): within-run SD 0.21 mg/dL, total SD 0.24 mg/dL
    Serum Control 2 (12.68 mg/dL): within-run SD 0.29 mg/dL, total SD 0.30 mg/dL
    Urine Pool 1 (2.41 mg/dL): within-run SD 0.11 mg/dL, total SD 0.11 mg/dL
    Urine Pool 2 (11.10 mg/dL): within-run SD 0.13 mg/dL, total SD 0.16 mg/dLSerum Control 1 (6.89 mg/dL): within-run SD 0.056 mg/dL, total SD 0.064 mg/dL
    Serum Control 2 (10.03 mg/dL): within-run SD 0.085 mg/dL, total SD 0.089 mg/dL
    Serum Control 3 (13.21 mg/dL): within-run SD 0.088 mg/dL, total SD 0.090 mg/dL
    Urine Pool 1 (3.24 mg/dL): within-run SD 0.048 mg/dL, total SD 0.059 mg/dL
    Urine Pool 2 (11.64 mg/dL): within-run SD 0.075 mg/dL, total SD 0.095 mg/dL
    Method Comparison (Serum/Plasma)Substantial equivalence to Beckman® SYNCHRON® Calcium Reagent.n=92. Regression: (HiChem) = -0.3 + 1.020 × (BMD® Results), r² = 0.887, s(y.x) = 0.21 mg/dL.n=153. Regression: (HiChem) = -0.3 + 1.005 x (Beckman® Results), r² = 0.924, s(y.x) = 0.20 mg/dL.
    Method Comparison (Urine)Substantial equivalence to Beckman® SYNCHRON® Calcium Reagent.Regression: (HiChem) = 0.2 + 1.022 × (BMD® Results), r² = 0.998, s(y.x) = 0.15 mg/dL.Regression: (HiChem) = 0.1 + 1.031 x (Beckman® Results), r² = 0.996, s(y.x) = 0.16 mg/dL.
    Chemical Additives (Interference)Biases less than a specified threshold (e.g.,
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