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    K Number
    K981769
    Device Name
    HICHEM PHOSPHORUS REAGENT KIT
    Manufacturer
    ELAN PHARMA, INC.
    Date Cleared
    1998-06-29

    (41 days)

    Product Code
    CEO
    Regulation Number
    862.1580
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HICHEM PHOSPHORUS REAGENT KIT

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

    HiChem Phosphorus Reagent is intended for the quantitative determination of inorganic phosphorus in serum, plasma and urine for the diagnosis and treatment of various disorders including parathyroid gland and kidney diseases, and vitamin D imbalance.

    Device Description

    The HiChem Phosphorus Reagent determines phosphorus by its reaction with molybdate in an acidic solution to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.

    The HiChem Phosphorus Reagent is an adaptation of the method first described by Simonsen and is intended for use with manual spectrophotometers or clinical analyzers which can automate the required manipulations.

    AI/ML Overview

    Here's a breakdown of the HiChem Phosphorus Reagent device's acceptance criteria and the study information as detailed in the provided document:

    This document describes a diagnostic reagent, not an AI/ML powered device, therefore some of the requested information (like MRMC studies, number of experts for ground truth, adjudication methods) is not applicable. I will provide the information that is applicable based on the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Manual Procedure)Reported Device Performance (Manual Procedure)Acceptance Criteria (SYNCHRON CX® Systems)Reported Device Performance (SYNCHRON CX® Systems)
    Linearity Range0.1 - 15 mgP/dL0.1 - 15 mgP/dL (Linear)1.0 - 12.0 mgP/dLAt least 1.0 - 12.0 mgP/dL (Linear)
    r² (Correlation)Implied high correlation1.000 (Manual)Implied high correlation1.000 (SYNCHRON CX®)
    Sensitivity0.1 mgP/dL (Claimed)0.05 mgP/dL (Observed, 0.1 mgP/dL, but sensitivity claim is 1.0 mgP/dL. There seems to be a discrepancy in the original text where it states "well below the claimed limit of 0.1 mgP/dL" after stating the sensitivity claim is 1.0 mgP/dL. I will assume the 1.0 mgP/dL is the correct claim for the SYNCHRON CX® system and 0.3 mgP/dL is well below that.)
    Precision (Within-run SD)Implied low variation0.02 - 0.07 mgP/dL (Serum)
    0.00 - 0.06 mgP/dL (Urine)Implied low variation0.08 - 0.11 mgP/dL (Serum)
    0.08 - 0.11 mgP/dL (Urine)
    Precision (Total SD)Implied low variation0.03 - 0.08 mgP/dL (Serum)
    0.00 - 0.07 mgP/dL (Urine)Implied low variation0.09 - 0.13 mgP/dL (Serum)
    0.11 - 0.13 mgP/dL (Urine)
    Comparison to Predicate (r²)Implied high correlation to predicate0.985 (Serum/Plasma), 0.999 (Urine)Implied high correlation to predicate0.972 (Serum/Plasma), 0.996 (Urine)
    Chemical Additive Bias
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