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    K Number
    K021482
    Device Name
    QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2002-07-30

    (83 days)

    Product Code
    NIY
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA

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

    The QUANTA Lite™ SLA (soluble liver antigen) kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH).

    Device Description

    The QUANTA Lite™ SLA (soluble liver antigen) kit is an enzyme-linked immunosorbent assay (ELISA).

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the QUANTA Lite™ SLA ELISA device, not a study report. Therefore, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving device performance as it would typically be found in a clinical study report or a 510(k) summary.

    However, based on the provided text, I can extract some relevant information and highlight what is missing.

    Information Extracted from the Document:

    • Device Name: QUANTA Lite™ SLA (Soluble Liver Antigen) ELISA
    • Intended Use: Semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum, intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH).

    Missing Information (and why it's missing from this type of document):

    This letter is an FDA clearance, which means the manufacturer submitted data in their 510(k) application demonstrating substantial equivalence to a predicate device. The detailed study results, acceptance criteria, sample sizes, ground truth establishment, etc., would be in the 510(k) Summary or the full 510(k) submission, which is not provided here.

    Therefore, I cannot populate the table or answer most of the specific questions.

    Placeholder for Answer Structure, if the full 510(k) Summary were available:

    Here's how I would structure the answer if the required information were present:

    1. Table of Acceptance Criteria and Reported Device Performance

    (This would typically outline performance metrics like Sensitivity, Specificity, Agreement with a predicate device, Precision, etc., and the thresholds set for acceptance.)

    Acceptance Criteria MetricAcceptance ThresholdReported Device PerformanceMeets Criteria?
    Sensitivity[e.g., > 90%][e.g., 92.5%]Yes
    Specificity[e.g., > 95%][e.g., 96.8%]Yes
    Positive Agreement[e.g., > 90%][e.g., 91.2%]Yes
    Negative Agreement[e.g., > 90%][e.g., 95.5%]Yes
    Overall Agreement[e.g., > 90%][e.g., 93.4%]Yes
    Intra-Assay Precision[e.g., CV
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