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510(k) Data Aggregation

    K Number
    K990222
    Device Name
    IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    1999-02-26

    (32 days)

    Product Code
    DHA
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K911796
    Why did this record match?
    Device Name :

    IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6

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

    IMMULITE HCG: For in vitro diagnostic use with the IMMULITE analyzer - for quantitative measurement of human chorionic gonadotropin (HCG) in serum, and for strictly qualitative determinations in urine, as an aid in the detection of pregnancy.

    IMMULITE 2000 HCG: For in vitro diagnostic use with the IMMULITE 2000 analyzer - for quantitative measurement of human chorionic gonadotropin (HCG) in serum, and for strictly qualitative determinations in urine, as an aid in the detection of pregnancy.

    Device Description

    IMMULITE HCG is a clinical use device intended for use with the IMMULITE Automated Immunoassay Analyzer.

    IMMULITE 2000 HCG is a clinical use device intended for use with the IMMULITE 2000 Automated Immunoassay Analyzer.

    AI/ML Overview

    This document is a 510(k) summary for the IMMULITE HCG and IMMULITE 2000 HCG reagent systems. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The provided text details:

    • Device identification: IMMULITE HCG and IMMULITE 2000 HCG.
    • Manufacturer and importer information.
    • Predicate devices: IMMULITE HCG (K911796) and IMMULITE 2000 HCG (K911796).
    • Description of devices: Clinical use devices for use with specific automated immunoassay analyzers.
    • Intended Use: Quantitative measurement of human chorionic gonadotropin (HCG) in serum and qualitative determinations in urine for pregnancy detection.
    • FDA Clearance: A letter from the FDA confirming substantial equivalence to predicate devices and allowing marketing.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the given text. This document focuses on regulatory clearance based on substantial equivalence to existing devices, not on the detailed performance studies that would typically define and test against specific acceptance criteria.

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