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510(k) Data Aggregation

    K Number
    K121045
    Device Name
    HUMAN ALBUMIN CSF KIT
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-06-19

    (439 days)

    Product Code
    DCF
    Regulation Number
    866.5040
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HUMAN ALBUMIN CSF KIT

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

    Human Albumin CSF Kit for use on SPAPLUS is intended for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) samples on the SPAPLUS analyser. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "The Binding Site Human Albumin CSF kit for use on SPAplus". It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain a detailed study report with acceptance criteria and device performance as described in your request. It's a regulatory approval, not a scientific publication presenting study data.

    Therefore, I cannot provide the specific information requested about acceptance criteria, sample sizes, ground truth establishment, or expert qualifications based on this document. These details would typically be found in the 510(k) submission itself or in a separate study report, not in the clearance letter.

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