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    K Number
    K974552
    Device Name
    DIAMEDIX IS-MEASLES IGG TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    1998-01-28

    (55 days)

    Product Code
    LJB
    Regulation Number
    866.3520
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIAMEDIX IS-MEASLES IGG TEST SYSTEM

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

    The Diamedix Is-Measles IgG test system is an Enzyme Immunoassay (EIA) for the semi-quantitative detection of IgG antibodies in human serum to measles virus as an aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals, and, when evaluating paired sera, as an aid in the diagnosis of measles infection.

    Device Description

    The Is-Measles IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Measles (rubeola) antigen in human serum

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Diamedix Is-Measles IgG Test System, based on the provided document:

    Acceptance Criteria and Reported Device Performance

    CriteriaAcceptance Criteria (Implied)Reported Device Performance
    Relative SensitivityNot explicitly stated, but generally expected to be high.Manual: 95.6% (95% CI: 91.1-98.2)
    MAGO: 94.0% (95% CI: 89.2-97.1)
    Relative SpecificityNot explicitly stated, but generally expected to be high.Manual: 100.0% (95% CI: 86.3-100.0)
    MAGO: 96.2% (95% CI: 80.4-99.9)
    Overall AgreementNot explicitly stated, but generally expected to be high.Manual: 96.2% (95% CI: 92.3-98.5)
    MAGO: 94.3% (95% CI: 90.0-97.1)
    Linearity (r-value)Not explicitly stated, but generally expected to be high (close to 1).Manual Calibrator Titration: r = 0.9969 (95% CI: 0.8557-0.9999)
    MAGO Calibrator Titration: r = 0.9983 (95% CI: 0.9161-1.0000)
    Precision (CV%)Not explicitly stated, but lower CV% is generally desired.Intra-Assay CV%: Ranged from 5.1% to 16.6% (across various sera/controls, Manual and MAGO)
    Inter-Assay CV%: Ranged from 7.0% to 31.6% (across various sera/controls, Manual and MAGO)
    Cross-ReactivityNo specific cross-reactivity expected with other common analytes.Tested against varicella, cytomegalovirus, herpes 2, and rubella. "No specific cross-reactivity should be expected with the Is-Measles IgG from these analytes."
    Manual vs MAGO Correlation (r-value)Not explicitly stated, but generally expected to be high (close to 1).Correlation coefficient (r) of 0.961 (95% CI for r: 0.949 to 0.9708) for EU/ml values.

    Study Information

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

    • Sample Size (Comparison Testing): 204 sera
    • Data Provenance: The sera were from "normal blood donors." It is not specified if the data is retrospective or prospective, nor the country of origin, though the applicant's address in Miami, FL, suggests a US origin for the donor samples.

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

    • Not applicable/Not provided. The ground truth for comparative performance was established by testing against a "commercially obtained anti-measles IgG test kit," not by expert consensus on individual samples.

    4. Adjudication method for the test set:

    • Not applicable. The study compares the device's results to a predicate device. There is no mention of an adjudication process for discrepant results between the two tests.

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

    • No. This is an assay for measles IgG, not an imaging device or AI diagnostic tool designed to assist human readers. The "MAGO" mentioned is likely an automated analyzer system for running the EIA, not an AI for interpretation.

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

    • Yes, implicitly. The performance characteristics (sensitivity, specificity, linearity, precision) are for the assay itself, which functions as a standalone diagnostic test. The comparison between "Manual" and "MAGO" (an automated system) indicates two modes of standalone operation for the test kit.

    7. The type of ground truth used:

    • Comparison Testing: Results from a "commercially obtained anti-measles IgG test kit" served as the reference standard (comparative ground truth) for evaluating relative sensitivity, specificity, and agreement.
    • Expected Values: Sera from randomly selected blood donors were used to establish expected values, indicating real-world prevalence, but not a "ground truth" for diagnostic accuracy.
    • Cross-Reactivity: Sera known to be negative for measles but positive for other specific viral antibodies were used.

    8. The sample size for the training set:

    • Not applicable. This is a laboratory diagnostic assay, not a machine learning algorithm that requires a distinct "training set." The development of the assay would involve various experimental and optimization phases, but these are not typically referred to as "training sets" in this context.

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

    • Not applicable, as there is no specified "training set" in the context of this device's development.
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