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510(k) Data Aggregation

    K Number
    K013544
    Device Name
    SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-11-15

    (22 days)

    Product Code
    DAP
    Regulation Number
    864.7320
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K003329
    Why did this record match?
    Device Name :

    SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096

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

    Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in Ddimer agglutination assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

    Device Description

    Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as a elevated control with patient citrated plasma in the Sigma Diagnostics AUTO D-dimer assay.
    Sigma Diagnostics AUTO D-Dimer Control, Level 2 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 2 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.

    AI/ML Overview

    This 510(k) summary describes a device that is a control solution for a diagnostic assay, not an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, etc.) are not applicable in this context.

    However, I will extract and present the information that is relevant to the provided document.

    Acceptance Criteria and Device Performance

    This submission is for a control solution, and its "performance" is assessed by showing substantial equivalence to a previously cleared control solution. The primary acceptance criterion here is the demonstration of substantial equivalence.

    Acceptance CriteriaReported Device Performance
    Substantial Equivalence to Predicate Device (Sigma Diagnostics AUTO D-Dimer Control, Level 2, Cat. No. A5217, K003329)The safety and effectiveness of the Sigma Diagnostics AUTO D-Dimer Control, Level 2 (Cat. No. A8096) has been demonstrated by its substantial equivalence to the predicate device.
    Stability post-reconstitutionStable for 3 days when stored at 2-8°C. Stable for 24 hours when stored at 18-26°C.

    Study Details (Applicable Information)

    1. Sample size used for the test set and the data provenance: Not applicable. This is a control solution, not a diagnostic device evaluated with patient samples in a traditional test set. The evaluation focuses on equivalence to another control product.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic performance is not relevant for a control solution's substantial equivalence review.
    3. Adjudication method for the test set: Not applicable.
    4. 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 not an AI/ML powered device.
    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML powered device.
    6. The type of ground truth used: For demonstrating substantial equivalence for a control solution, the "ground truth" implicitly refers to the established performance characteristics and intended use of the legally marketed predicate device. The comparison would be made against the predicate's known behavior in the specified assay.
    7. The sample size for the training set: Not applicable. This is not an AI/ML powered device.
    8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML powered device.
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