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    K Number
    K972342
    Device Name
    REAADS PROTEIN C ANTIGEN TEST KIT
    Manufacturer
    REAADS MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-06

    (104 days)

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

    The REAADS Protein C Antigen Test Kit is an in vitro diagnostic assay for the quantitative determination of plasma levels of human Protein C (as a percent of normal concentration) by enzyme linked immunosorbent assay (ELISA). Plasma levels of Protein C may be used in conjunction with other assays as an aid in diagnosing congenital or acquired Protein C deficiencies associated with thrombotic disease.

    Device Description

    The REAADS Protein C Antigen Test Kit is a sandwich enzyme linked immunosorbent assay (ELISA). The capture antibody specific for human Protein C is coated to 96 microwell polystyrene plate. Diluted patient plasma is incubated in the wells, allowing any available Protein C to bind to the anti-human Protein C antibody bound to the plastic. The plates are washed to remove any unbound Protein C or other plasma molecules. Bound Protein C is quantitated using an HRP conjugated anti-human Protein C detection antibody. Any unbound conjugated anti-human Protein C is washed away after an incubation period. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured spectrophotometrically at 450nm in optical density (O.D.) units. Protein C Antigen relative percent concentrations in patient plasma is determined against a curve made from a reference plasma.

    AI/ML Overview

    The provided text describes the REAADS Protein C Antigen Test Kit, an in vitro diagnostic assay. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided information:

    Acceptance Criteria and Study Details for REAADS Protein C Antigen Test Kit

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Substantial equivalence to a legally marketed predicate device (Helena Protein C Antigen Rocket EID Method).Coefficient of correlation (r) for the entire population = 0.949
    P-value (by single factor ANOVA) = 0.838
    Statistical similarity of results between the two methods.The reported r-value and p-value indicate statistical similarity, with the P-value being well above common significance thresholds (e.g., 0.05).
    Performance comparability."in general the performance was comparable"

    2. Sample Size and Data Provenance

    • Test Set Sample Size: Not explicitly stated. The text mentions "Test results for clinical samples" and "the entire population" for the correlation analysis, but does not provide a specific number of samples.
    • Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. It refers to "patient plasma" and "clinical samples," suggesting human samples.

    3. Number and Qualifications of Experts for Ground Truth

    • Not applicable for this type of device. This device is an in vitro diagnostic assay that measures Protein C antigen levels. The "ground truth" for its performance is typically established by comparing its quantitative measurements to a reference method or a validated predicate device, not by expert consensus on interpretations.

    4. Adjudication Method

    • Not applicable. See explanation above. The performance evaluation relies on quantitative comparison between assays, not subjective interpretation requiring adjudication.

    5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

    • No. This is not an imaging or diagnostic interpretation device where human readers are involved in the direct output that is being compared. The study compares the quantitative results of two laboratory tests.

    6. Standalone Performance Study

    • Yes, a standalone comparison was performed. The study directly compares the quantitative results of the REAADS Protein C Antigen Test Kit (algorithm only, as it's an ELISA test) to a predicate device (Helena Protein C Antigen Rocket EID Method). The results reported (r=0.949, p=0.838) are indicative of the device's standalone performance compared to the predicate.

    7. Type of Ground Truth Used

    • Comparison to a Legally Marketed Predicate Device. The "ground truth" or reference standard for this substantial equivalence claim is the performance of the Helena Protein C Antigen Rocket EID Method. The study directly compares the REAADS kit's results to those obtained using the Helena method.

    8. Sample Size for the Training Set

    • Not applicable. This device is a quantitative assay, not a machine learning model that requires a "training set" in the typical sense. Product development for such assays involves internal validation and optimization, but the term "training set" is not relevant here.

    9. How the Ground Truth for the Training Set was Established

    • Not applicable. As a quantitative assay, there is no "training set" for ground truth in the machine learning context. The assay's analytical performance (e.g., sensitivity, specificity, accuracy, precision) is established through laboratory experiments and comparison to established methods or reference materials.
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