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510(k) Data Aggregation

    K Number
    K161721
    Device Name
    Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
    Manufacturer
    Diazyme Laboratories
    Date Cleared
    2016-09-20

    (90 days)

    Product Code
    CDD,JIT,JJX
    Regulation Number
    862.1810
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set

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

    The Diazyme Vitamin B12 Assay is for the quantitative determination of Vitamin B12 levels in human serum. Measurements of vitamin B12 may be used in the diagnosis of B12 deficiency. For in vitro diagnostic use only.

    The Diazyme Vitamin B12 Calibrator Set is intended for use in the Diazyme Vitamin B12 Assay. For in vitro diagnostic use only.

    The Diazyme Vitamin B12 Control Set is intended for use as quality controls for the Diazyme Vitamin B12 Assay. For in vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the Diazyme Vitamin B12 Assay, which is an in vitro diagnostic device used to quantitatively determine Vitamin B12 levels in human serum for the diagnosis of B12 deficiency. The document describes the regulatory classification and general information about the device, but it does not contain the detailed acceptance criteria and study results you requested for a device proving it meets acceptance criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on regulatory approval and indications for use, not a performance study.

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