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510(k) Data Aggregation

    K Number
    K970239
    Device Name
    IS-ANTI-SCL-70 TEST SYSTEM (720-280)
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    1997-04-08

    (77 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The assay is intended for use in detecting antibodies to Scl-70 antigen in a single human serum sample. The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders.

    Device Description

    The Is-anti-Scl-70 Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Scl-70 antigen in human serum.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Is-anti-Scl-70 Test System:

    This document focuses on the performance characteristics of an in vitro diagnostic device (IVD), specifically an Enzyme-Linked Immunosorbent Assay (ELISA) for detecting antibodies to Scl-70 antigen. For IVDs, "acceptance criteria" are usually demonstrated through tests of sensitivity, specificity, accuracy (agreement), precision, linearity, and and cross-reactivity compared to a predicate device or established reference methods. The "study" described is the validation study performed to demonstrate these characteristics.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state "acceptance criteria" as distinct numerical thresholds for approval. Instead, it presents performance characteristics and compares them to a predicate device. For IVDs, the reported performance is what demonstrates the device is "safe and effective for its intended use" as compared to the predicate.

    Given the context of a 510(k) summary, the implicit acceptance criteria would be substantial equivalence to the predicate device. This means the new device performs at least as well as, or comparably to, the legally marketed predicate device.

    Performance MetricAcceptance Criteria (Implicit: Comparable to Predicate)Reported Device Performance (Manual)Reported Device Performance (MAGO)
    Relative SensitivityHigh agreement with predicate device for positive samples.88% (21/24) with 95% CI: 68-97%92% (22/24) with 95% CI: 73-99%
    Relative SpecificityHigh agreement with predicate device for negative samples.100% (138/138) with 95% CI: 97-100%99% (138/139) with 95% CI: 96-100%
    AgreementHigh overall agreement with predicate device.98% (159/162*) with 95% CI: 95-100%98% (160/163) with 95% CI: 95-100%
    LinearityHigh degree of linearity throughout the testing range.R-squared = 0.9873R-squared = 0.9888
    Precision (Intra-CV%)Acceptable variability for both negative and positive samples. (Implicit: typically
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