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510(k) Data Aggregation

    K Number
    K252520
    Date Cleared
    2025-09-11

    (31 days)

    Product Code
    Regulation Number
    862.3650
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K223781, K232898

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

    The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid collected by Quantisal™ or Quantisal™ II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid to be used with clinical analyzers. This assay is calibrated against hydrocodone.

    The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

    The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/MS are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.

    Device Description

    The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is a homogenous enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid. The assay is intended for use in laboratories with clinical chemistry analyzers for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid collected with Quantisal™ Oral Fluid Collection Device or Quantisal™ II Oral Fluid collection device.

    AI/ML Overview

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