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510(k) Data Aggregation

    K Number
    K993635
    Device Name
    MDI SM/RNP TEST
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-01-10

    (75 days)

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

    MDI SM/RNP TEST

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

    The MDI Sm/RNP Test reagents (P/N: RNKi-G) are intended for the semi quantitative determination of IgG antibodies to Sm/RNP in human serum. The principal diagnostic value of this test is detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases.

    The MDI Sm/RNP Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human Sm/RNP in human serum. The test is intended as an aid in the diagnosis of theumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.

    Device Description

    The Micro Detect, Inc. Sm/RNP reagent ( MDI Sm/RNP Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.

    AI/ML Overview

    Here's an analysis of the provided text regarding the MDI Sm/RNP Test, outlining the acceptance criteria and study details:

    Acceptance Criteria and Device Performance

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance
    Relative SensitivityNot explicitly stated (implied to be comparable to predicate)96.2%
    Relative SpecificityNot explicitly stated (implied to be comparable to predicate)97.9%
    Precision (Inter-assay)Not explicitly stated2.29-5.59
    Precision (Intra-assay)Not explicitly stated2.07-7.01
    StabilityOne year at 2-8°COne year at 2-8°C (predicted from stress, real-time monitored)

    Note: The document states the device is "substantially equivalent to those obtained by using predicate assays," which implies the acceptance criteria for sensitivity and specificity were met by matching or exceeding the performance of the predicate device. The exact numerical criteria are not explicitly listed, but the reported values are presented as meeting these implicit criteria.

    Study Details:

    The provided document is a summary of 510(k) safety and effectiveness information, not a detailed study report. Therefore, many of the specific details requested about the study methodology are not present in the provided text.

    2. Sample size used for the test set and the data provenance:

    • Sample Size: Not specified in the provided text.
    • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Number of Experts: Not specified.
    • Qualifications of Experts: Not specified.

    4. Adjudication method for the test set:

    • Adjudication Method: Not specified.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • This device is an in-vitro diagnostic (IVD) lab test (Enzyme Immunoassay Kit), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • This device is a standalone test; it performs the semi-quantitative determination of IgG antibodies. Its performance (sensitivity, specificity, precision) is what's reported. Human intervention is limited to performing the manual procedure, not interpreting results in conjunction with an AI.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • The document implies ground truth was established by comparison to "predicate assays" and through clinical performance for "detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases." This suggests the ground truth was likely established through a combination of:
      • Clinically established diagnoses: Patients with confirmed rheumatoid diseases vs. healthy controls or other conditions.
      • Comparison to a gold standard or well-established reference method for Sm/RNP antibody detection (the "predicate assays").
      • Outcome data is not explicitly stated but is inherent in the "aid in patients with rheumatoid diseases" statement.

    8. The sample size for the training set:

    • Sample Size: Not specified. Information about training sets is typically relevant for machine learning algorithms, which is not the primary focus of this type of IVD kit (though internal assay development would involve optimizing reagents).

    9. How the ground truth for the training set was established:

    • Ground Truth Establishment: Not specified. Similar to point 8, this detail is less explicit for a chemical/biological assay kit than for an AI algorithm. Ground truth for optimizing such a kit would generally involve known positive and negative samples, often characterized by reference labs or with clinically confirmed diagnoses.
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