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510(k) Data Aggregation

    K Number
    K082227
    Device Name
    MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
    Manufacturer
    SEBIA
    Date Cleared
    2009-03-26

    (231 days)

    Product Code
    GKA
    Regulation Number
    864.7415
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227

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

    The MINICAP HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System. The MINICAP performs all sequences automatically to obtain a complete hemoglobin profile for qualitative or quantitative anailysis of hemoglobins. The assay is performed on sedimented, centrifuged or washed red blood cells; washing red blood cells is not essential to perform the analysis. For In Vitro Diagnostic Use

    Device Description

    The MINICAP HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System. The MINICAP performs all sequences automatically to obtain a complete hemoglobin profile for qualitative or quantitative anailysis of hemoglobins. The assay is performed on sedimented, centrifuged or washed red blood cells; washing red blood cells is not essential to perform the analysis.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "MINICAP HEMOGLOBIN(E) Kit, Model 2207, 2227." This document certifies that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain the specific information requested about acceptance criteria and detailed study results. It is a regulatory clearance document, not a scientific study report or clinical trial summary.

    Therefore, I cannot extract the following information from the provided text:

    1. A table of acceptance criteria and the reported device performance: This document only states that the device is "substantially equivalent" to predicate devices, but doesn't provide specific performance metrics or acceptance criteria used to establish that equivalence.
    2. Sample sizes used for the test set and data provenance: Not mentioned.
    3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
    4. Adjudication method for the test set: Not mentioned.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
    6. If a standalone performance study was done: Not explicitly detailed, beyond the claim of substantial equivalence.
    7. The type of ground truth used: Not mentioned.
    8. The sample size for the training set: Not mentioned.
    9. How the ground truth for the training set was established: Not mentioned.

    The document primarily focuses on regulatory approval and the device's intended use: "designed for the separation of the normal hemoglobins (A, F and A2) and for the detection of the major hemoglobin variants (especially S, C, E or D), by electrophoresis in alkaline buffer (pH 9.4) with the MINICAP System."

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