LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972156
    Device Name
    QUIX RAPID E. COLI O157 STRIP TEST
    Manufacturer
    GUARDIAN SCIENTIFIC, CORP.
    Date Cleared
    1997-10-16

    (129 days)

    Product Code
    GMZ
    Regulation Number
    866.3255
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUIX RAPID E. COLI O157 STRIP TEST

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

    The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay for the qualitative detection of E. coli O157 in human feces. The test is designed to be used as an aid to the diagnosis of diarrhea caused by E. coli 0157 and as an adjunct to culture methodology.

    Device Description

    The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Quix™ Rapid E. Coli 0157 Strip Test". It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter acknowledges receipt of the 510(k) notification and states that the device is deemed "substantially equivalent" to predicate devices, allowing its marketing. It outlines regulatory requirements but does not delve into performance testing details.

    Therefore, I cannot extract the requested information the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1