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510(k) Data Aggregation

    K Number
    K981573
    Device Name
    UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1998-09-15

    (134 days)

    Product Code
    JFH
    Regulation Number
    862.1020
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE

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

    The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of PAP level in human serum to aid in the management and monitoring the effectiveness of various therapeutic treatments of prostate cancer patients. (for Professional use only)

    Device Description

    The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA).

    AI/ML Overview

    This document is a marketing authorization letter for the UBI MAGIWEL™ PAP EIA Quantitative device (K981573) from the FDA dated September 15, 1998. It states that the device is substantially equivalent to legally marketed predicate devices. The document also includes an "Indications for Use" statement. However, it does not contain any information regarding acceptance criteria, study details, or performance data of the device.

    Therefore, I cannot provide the requested information based on the provided text. The document is solely an authorization letter and does not include the technical details of the device's performance or the studies conducted to support its claims.

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