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510(k) Data Aggregation

    K Number
    K050077
    Device Name
    SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
    Manufacturer
    ARKRAY, INC.
    Date Cleared
    2005-02-15

    (34 days)

    Product Code
    CIC,JGJ,JGZ
    Regulation Number
    862.1145
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS

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

    The SpotChem II Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. Serum calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

    The SpotChem II Magnesium test is intended to measure the concentration of magnesium in serum, plasma and whole blood. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

    The SpotChem II Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in serum, plasma and whole blood. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Arkray SpotChem II Calcium, Magnesium, and Blood Urea Nitrogen Tests. This type of document declares substantial equivalence to a predicate device and does not typically include detailed studies proving device performance against specific acceptance criteria. The information requested, such as sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is usually found within the 510(k) submission itself (which is not provided) or in detailed clinical study reports, not in the FDA's clearance letter.

    Therefore,Based on the provided FDA 510(k) clearance letter, I cannot provide the detailed information requested regarding the acceptance criteria and the study that proves the device meets those criteria.

    Here's why:

    • Nature of the Document: This document is an FDA clearance letter, which states that the device is "substantially equivalent" to legally marketed predicate devices. It does not contain the detailed study results, acceptance criteria, or methodological specifics that were submitted to the FDA to demonstrate this substantial equivalence. These details would be in the original 510(k) submission, which is not provided.
    • Information Not Present: The letter does not include:
      • A table of acceptance criteria and reported device performance.
      • Sample sizes for test sets, data provenance, or expert qualifications for ground truth.
      • Adjudication methods.
      • Information about multi-reader multi-case (MRMC) studies or standalone performance.
      • Details on the type of ground truth used or the sample size and ground truth establishment for the training set.

    The letter mentions that the FDA reviewed the premarket notification, implying that such studies and acceptance criteria were part of that submission. However, the clearance letter itself only states the FDA's decision based on that review.

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