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510(k) Data Aggregation

    K Number
    K101319
    Device Name
    IMMULISA DSDNA ANTIBODY ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2010-12-09

    (212 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMMULISA DSDNA ANTIBODY ELISA

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

    An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to double stranded DNA (dsDNA) in human serum, as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter for an in-vitro diagnostic device, not an AI/ML medical device. As such, the typical acceptance criteria and study designs for AI/ML devices (like sample sizes for test sets, expert ground truth, MRMC studies) are not applicable or found in this type of document.

    This document describes the regulatory clearance of the ImmuLisa™ dsDNA Antibody ELISA, an enzyme-linked immunosorbent assay, as an aid in diagnosing systemic lupus erythematosus (SLE).

    Therefore, I cannot fulfill the request as the provided text relates to an IVD device and not an AI/ML device, and thus does not contain the information required to answer the prompt.

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