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510(k) Data Aggregation

    K Number
    K111363
    Device Name
    PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2011-12-06

    (204 days)

    Product Code
    JXN,DLJ,LAS
    Regulation Number
    862.3700
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL

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

    The EasyRA PPX reagent is intended for the qualitative and semi-quantitative measurement of Propoxyphene (PPX) in human urine, using MEDICA's EasyRA Chemistry Analyzer in clinical laboratories. The cut-off point of the assay is 300ng/ml, and provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory method. The semi-quantitative mode is intended to enable laboratories to determine the appropriate dilution of the specimen for confirmation by a reference method such as GC/MS or LC/MS and to allow laboratories to establish effective quality control procedures for the PPX assay.

    Medica's Propoxyphene (PPX) Calibrators are intended for the calibration of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica's PPX reagent on the EasyRA clinical chemistry analyzer.

    Medica's Propoxyphene (PPX) QC Materials are intended for the validation of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica's PPX reagent and PPX calibrator on the EasyRA clinical chemistry analyzer.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for in vitro diagnostic devices (IVDs) related to Propoxyphene (PPX) testing. It does not contain information about acceptance criteria or a study proving device performance as requested.

    The document states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This means the device's performance is considered similar enough to existing devices, and a separate study demonstrating new acceptance criteria or performance against such criteria is not typically required in a 510(k) for substantial equivalence.

    Therefore, I cannot provide the requested information from the given text because it is not present.

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