LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K964270
    Device Name
    UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
    Manufacturer
    UNIVERSAL REAGENTS, INC.
    Date Cleared
    1996-12-18

    (54 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K792507
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indicated use - Factor deficient plasma, Factor - V is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.

    Environment of use: Clinical laboratories

    Device Description

    Factor deficient plasma to be free of antigen of Factor V utilized in in vitro diagnostic use

    AI/ML Overview

    The provided text describes a medical device, "Factor deficient coagulation plasma - V," and compares it to a predicate device, Helena - K792507 - Factor V. The document does not describe a study involving machine learning or AI. Therefore, I cannot extract information related to AI/ML acceptance criteria, study design (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set details.

    The document focuses on the intended use, design, materials, and performance testing for a diagnostic reagent. The performance testing section mentions:

    Acceptance Criteria and Reported Device Performance (as described for this diagnostic reagent)

    Acceptance Criteria (Performance Testing)Reported Device Performance (Intended Product)
    Compare assay to known sampleYes
    Negative by FDA approved test for HIV 1/2 and HBsAGYes
    Negative by FDA approved test for HCV and HIV-1agYes
    Deficiency of relevant factor less than 1%Yes
    Negative for HIV and HBsAGYes
    Negative for HCV, HIV-1agYes
    No inhibitor presentYes

    Study Details Related to AI/ML: Not applicable. The document describes a traditional in-vitro diagnostic device, not an AI/ML system. There is no information regarding:

    1. Sample size for test set or data provenance.
    2. Number or qualifications of experts.
    3. Adjudication method.
    4. MRMC comparative effectiveness study or effect size.
    5. Standalone performance.
    6. Type of ground truth (beyond "known sample" for assay comparison).
    7. Sample size for training set.
    8. How ground truth for training set was established.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1