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510(k) Data Aggregation

    K Number
    K973938
    Device Name
    ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
    Manufacturer
    SFRI, INC.
    Date Cleared
    1998-02-04

    (112 days)

    Product Code
    JJQ
    Regulation Number
    862.2300
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER

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

    THE ALPHA 4 LS IS INTENDED TO AUTOMATE MICROTITER PLATE PROCESSOR AND READER THAT MEASURES THE LIGHT ABORBANCE OR LUMINESCENCE OF REACTION PRODUCTS IN EITHER MODE.

    Device Description

    ALPHA 4 LS Automated Microtiterplate Processor and Reader

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the "Alpha 4 LS Automated Microtiterplate Processor and Reader". It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

    However, this letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. These details are typically found in the 510(k) submission itself, which is not provided here.

    Therefore, I cannot fulfill your request for detailed information about acceptance criteria and the study proving the device meets them based solely on the provided text. The document is essentially a regulatory approval letter, not a technical performance report.

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