LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020625
    Device Name
    SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2002-05-06

    (69 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346

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

    The test system will be used in laboratories to separate serum ALP isoenzymes. Elevated bone isoenzyme can be found in conditions of physiologic bone growth, metastatic carcinoma and as rickets. Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver. Intestinal isoenzymes can be seen in patients with intestinal disease in particular after a meal. Intestinal Isoenzymes occur in blood type O or B after a meal.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the SPIFE 2000/3000 ALP device. It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria.

    The letter states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices. This determination is based on a comparison to existing devices, not on a new study providing specific performance metrics against pre-defined acceptance criteria.

    Therefore, I cannot extract the requested information from the provided text. The document is primarily an administrative letter confirming regulatory clearance.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1