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510(k) Data Aggregation

    K Number
    K050662
    Device Name
    QUANTA LITE SP100 ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2005-06-13

    (90 days)

    Product Code
    NUM
    Regulation Number
    866.5090
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    NUM

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

    The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of primary biliary cirrhosis (PBC).

    Device Description

    The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA).

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "QUANTA Lite™ sp100 ELISA" device, which is an enzyme-linked immunosorbent assay for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum, intended to aid in the diagnosis of primary biliary cirrhosis (PBC).

    However, the provided document does not contain any information regarding specific acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. It is a regulatory approval letter and an "Indications For Use" statement, not a scientific study report.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

    To answer your question, I would need a more detailed technical report, clinical study summary, or an FDA review memorandum that outlines the device's validation process and performance data.

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