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510(k) Data Aggregation

    K Number
    K030600
    Device Name
    AUTION JET AJ-4270 URINE ANALYZER
    Manufacturer
    INTERNATIONAL REMOTE IMAGING SYSTEMS
    Date Cleared
    2003-07-11

    (136 days)

    Product Code
    KQO, JIL, JIO
    Regulation Number
    862.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL REMOTE IMAGING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AUTION™ JET AJ-4270 Urine Analyzer (AUTION™ JET) is a semi-automated urine analyzer and is intended for use with the AUTION™ Sticks 10EA multi-parameter test strips for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocytes, and color. The AUTION™ JET Analyzer and AUTION™ Sticks 10EA test strips are intended for mutually exclusive use as a system.
    Device Description
    The AUTION™ JET AJ-4270 Urine Analyzer (AUTION™ JET) consists of an analyzer and accessories. ARKRAY also offers a hand-held Bar Code Reader for use with the AUTION™ JET. The AUTION™ JET Analyzer is designed for use only with the AUTIONTM Sticks 10EA multi-parameter test strips.
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    K Number
    K013783
    Device Name
    AUTION MAX AX-4280 URINALYSIS SYSTEM
    Manufacturer
    INTERNATIONAL REMOTE IMAGING SYSTEMS
    Date Cleared
    2002-01-18

    (65 days)

    Product Code
    KQO, CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, JRE, LJX
    Regulation Number
    862.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL REMOTE IMAGING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AUTION MAX AX-4280 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose (GLU), protein (PRO), bilirubin (BIL), urobilinogen (URO), pH, blood (BLD), ketones (KET), nitrite (NIT), leukocytes (LEU), specific gravity (SG), turbidity, and color. The AUTION MAX is intended for use only with the AUTION Sticks 9EB multi-parameter test strips.
    Device Description
    The AUTION MAX Urinalysis System consists of an Analyzer, Sampler, and accessories. ARKRAY also offers an external printer and hand-held Bar Code Reader for use with the AUTION MAX. The sample-handling capacity of the AUTION MAX can be expanded through the use of the Extensional Sampler. The AUTION MAX Analyzer is designed for use with the AUTION Sticks 9EB multiparameter test strips. The proposed AUTION MAX Analyzer contains: - Mechanical systems for handling the test strips, urine specimens, wash solution, and system waste - Measurement units for reading the test strips and analyzing the physical properties of the urine - Software control system for automation of Analyzer and Sampler operation, processing commands and information input by the user, displaying system and specimen information, and monitoring system functions - RS-232C interface for exporting measurement results and urine specimen identification information The AUTION MAX uses a rack system for urine specimen handling. The AUTION MAX Sampler automatically feeds sample racks to the Analyzer. The Sampler contains a Bar Code Reader for urine specimen identification. The proposed AUTION MAX Analyzer uses reflectance spectroscopy for the measurement of the urine analytes GLU, PRO, BIL, URO, pH, BLD, KET, NIT, LEU, and urine color. Urine SG is determined using the refractive index method, and turbidity is evaluated by measuring the transmission and scattering of light passing through the urine specimen.
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