LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K961053
    Device Name
    SERAQUEST RUBELLA IGG
    Manufacturer
    QUEST INTL., INC.
    Date Cleared
    1996-09-04

    (170 days)

    Product Code
    LFX
    Regulation Number
    866.3510
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SERAQUEST RUBELLA IGG

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

    For the qualitative and quantitative detection of human IgG antibodies to Rubella in human serum by enzyme immunoassay, to aid in the determination of infection with rubella virus. When used as a qualitative test, SeraQuest Rubella IgG aids in the assessment of the patient's immunological response to rubella. For manual use, or for use with the HyPrep System Plus.

    Device Description

    The SeraQuest™ Rubella IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against rubella virus, in human serum.

    The Calibrators in the SeraQuest Rubella IgG test set have been assigned Index values based on an in-house standard, and International Unit values (IU / ml) which are traceable to the WHO International Reference Preparation of Anti-rubella Serum. Test results may be reported as Index values, or as IU / ml.

    AI/ML Overview

    Here's an analysis of the provided text, extracting the information requested for acceptance criteria and the study that proves the device meets them:

    1. A table of acceptance criteria and the reported device performance

    Based on the "Summary of Clinical Testing" section, the acceptance criteria are implied by the agreement rates, particularly the overall agreement excluding equivocal results.

    Acceptance Criteria (Implied)Reported Device Performance
    Overall agreement with predicate device ≥ 95.2% (lower bound of 95% CI)97.2% (95% Confidence Interval = 95.2 to 99.3) (excluding equivocal results)
    Relative sensitivity with predicate device ≥ 94.3% (lower bound of 95% CI)94.3 to 99.1 (95% CI)
    Relative specificity with predicate device ≥ 95.4% (lower bound of 95% CI)95.4 to 100 (95% CI)

    2. Sample sized used for the test set and the data provenance

    • Sample Size: 260 sera
    • Data Provenance: "normal blood donors." The country of origin is not explicitly stated, but given the applicant's address (North Miami, FL), it's highly likely to be the USA. The data is retrospective, as the samples were collected and then tested.

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

    Not applicable. The "ground truth" for this study was established by comparing the device's results against a predicate device (INCSTAR Rubella IgG Clin-ELISA™ kit), not through expert interpretation of a gold standard.

    4. Adjudication method for the test set

    Not applicable. There was no expert adjudication process described, as the comparison was against a predicate device's results.

    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

    Not applicable. This is a study for a diagnostic assay (SeraQuest™ Rubella IgG) for detecting antibodies, not an AI-assisted imaging or diagnostic tool involving human readers.

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

    Yes, this study is a standalone performance study. The SeraQuest™ Rubella IgG test is an enzyme immunoassay that produces objective results (absorbance readings converted to Index values or IU/ml), and its performance was evaluated without human intervention in the interpretation process beyond reading the instrument results.

    7. The type of ground truth used

    The "ground truth" for this study was the results obtained from a predicate device, the Rubella IgG Clin-ELISA™ kit from INCSTAR Corporation. This is a common approach for demonstrating substantial equivalence for new diagnostic assays.

    8. The sample size for the training set

    The document does not explicitly state a separate "training set" sample size. For an in vitro diagnostic assay like this, development often involves internal validation and optimization with various samples, but a formal distinction between a "training set" and "test set" in the machine learning sense is not typically documented in this type of submission. The 260 sera were used for the clinical validation/test set.

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

    As there's no explicitly defined "training set" in the context of this submission, this question is not fully applicable. However, the device itself was developed and calibrated using an "in-house standard" and International Unit values traceable to the WHO International Reference Preparation of Anti-rubella Serum. This process of using international standards and internal controls would form the basis of establishing "ground truth" during device development.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1