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510(k) Data Aggregation

    K Number
    K963383
    Device Name
    HICHEM ALP/AMP REAGENT KIT
    Manufacturer
    HICHEM DIAGNOSTICS
    Date Cleared
    1996-09-23

    (27 days)

    Product Code
    CKF
    Regulation Number
    862.1050
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HICHEM ALP/AMP REAGENT KIT

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

    HiChem ALP/AMP Reagent (product no. 70001) is intended for the quantitative determination of alkaline phosphatase in serum and plasma. The principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine.

    Device Description

    The HiChem ALP/AMP Reagent determines alkaline phosphatase by enzymatic hydrolysis of p-nitrophenylphosphate to p-nitrophenoxide at alkaline pH. The HiChem ALP/AMP Reagent is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part ALP/AMP Substrate and 5 parts ALP/AMP Reagent Buffer. The ALP/AMP Substrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.

    AI/ML Overview

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

    Important Note: The provided document is a 510(k) summary for a diagnostic reagent, not a medical device in the typical sense of AI-powered imaging or diagnostic software. Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone performance for AI, training set details) are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence to existing, legally marketed devices through analytical performance characteristics.

    Acceptance Criteria and Reported Device Performance

    Device: HiChem ALP/AMP Reagent (product no. 70001)

    Intended Use: Quantitative determination of alkaline phosphatase (ALP) in serum and plasma.

    Acceptance Criteria CategoryAcceptance Criteria (Stated or Implied)Reported Device Performance
    Manual Procedure
    Linearity (30°C)Linear to at least 900 U/LLinear to at least 900 U/L (Recoveries at 30°C) = -1.7 U/L + 1.005 x (Standard Activity), r² = 0.9998, sy.x = 6.5 U/L
    Linearity (37°C)Linear to at least 900 U/LLinear to at least 900 U/L (Recoveries at 37°C) = 2.9 U/L + 0.969 x (Standard Activity), r² = 0.9998, sy.x = 8.0 U/L
    Precision (37°C)Replicate assay with acceptable within-run and total SD values (implied by tabulated results)See table below for detailed precision results at 37°C (n=30 for each control).
    Comparison to MAS ALP ReagentAcceptable correlation and agreement (implied by regression statistics)r² = 0.9986, (HiChem Results) = -0.2 U/L + 1.058 x (MAS Results), sy.x = 5.5 U/L
    Anticoagulant InterferenceBias
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