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510(k) Data Aggregation

    K Number
    K170091
    Device Name
    UA-Cellular Complete
    Manufacturer
    Streck
    Date Cleared
    2017-02-09

    (30 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Product Code :

    JJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the following instruments and testing methods: Sysmex® UF-1000i™ Automated Urine Particle Analyzer: Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak; the Arkray AUTION HYBRID™ AU-4050 fully-automated integrated urine analyzer: utilizing the Aution sticks 10EA Reagent strips: Siemens Clinitek Status® line of automated chemistry strip reader analyzers; Manual Reading of Urine Refractive Index; Manual Reading of the Siemens Multistix® 10SG Reagent Strips, and the Siemens Clinitest® hCG Pregnancy test. The list of assayed parameters includes: Sysmex® UF-1000i™: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals Arkray AU-4050: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals Arkray AU-4050 with Aution sticks 10EA Reagent strips : Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), pH (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Turbidity (As Measured) Siemens ® Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured) Siemens Clinitek Status System line with Multistix 10SG Reagent Strips: Glucose (mg/d); Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Mesured), pH (As Measured), Protein (me/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured) Siemens Multistix 10SG Reagent Strips: Glucose (mg/dL), Bilirubin (As Measured), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As measured) Siemens Clinitest hCG Pregnancy Test Cassette: Pregnancy hCG (As Measured) Manual Confirmatory Testing: Refractive Index (nD)
    Device Description
    UA-Cellular® Complete is a three-level, in-vitro diasis control that contains the following: stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulative medium. Analyte levels are adjusted with appropriate chenicals. The product is packaged in a 4 oz. amber plastic bottle with a foil-lined flip-top cap. The product must be stored at 2-10°C.
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    K Number
    K142262
    Device Name
    AUTION CHECK PLUS
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2015-04-10

    (239 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Product Code :

    JJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.
    Device Description
    The AUTION CHECK Plus, is a two level liquid control prepared from human urine source material with added stabilizers and preservatives. Level 1 is positive for bilirubin and urobilinogen and Level 2 is positive for glucose, protein, blood, ketone, nitrite and leukocytes.
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    K Number
    K131444
    Device Name
    UA-CELLULAR COMPLETE
    Manufacturer
    Streck
    Date Cleared
    2014-01-29

    (254 days)

    Product Code
    JJW, PAN
    Regulation Number
    862.1660
    Why did this record match?
    Product Code :

    JJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the Sysmex® UF-1000i™ Automated Urine Particle Analyzer and the Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak. The list of assayed parameters includes: Sysmex UF-1000i:RBC(/μL), WBC//μL), Epithelial (/uL), Cast, Bacteria (/uL), Crystals, Conductivity (mS/cm) Siemens Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)
    Device Description
    UA-Cellular Complete is an in vitro diagnostic control prepared from stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulated urine sediments in a preservative medium. Analyte levels are adjusted with appropriate chemicals.
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    K Number
    K110846
    Device Name
    RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
    Manufacturer
    RANDOX LABORATORIES LIMITED
    Date Cleared
    2011-09-30

    (186 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Product Code :

    JJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox Urinalysis Controls (URNAL Control 1 and URNAL Control 2) are urine controls containing Bilirubin, Blood, Creatinine, Crystals, Galactose, Glucose, hCG, Ketones, Leukocytes, Microalbumin, Nitrite, pH, Protein, Red Blood Cells, Specific Gravity, Urobilinogen and White Blood Cells. The Randox Urinalysis controls (URNAL Control 1 and URNAL Control 2) are intended for in vitro diagnostic use in the quality control of urine test strips for the analytes; Bilirubin, Blood, Creatinine, Glucose, Ketones, Leukocytes, Microalbumin, Nitrite, pH. Protein, Specific Gravity and Urobilinogen. This control is also intended for the evaluation of microscopic test procedures for Crystals, Red Blood Cells and White Blood Cells and also for the confirmatory tests hCG and Galactose. This in vitro diagnostic device is intended for prescription use only
    Device Description
    The Randox Urinalysis Controls (URNAL Control 1 and URNAL Control 2) are urine controls containing Bilirubin, Blood, Creatinine, Crystals, Galactose, Glucose, hCG, Ketones, Leukocytes, Microalbumin, Nitrite, pH, Protein, Red Blood Cells, Specific Gravity, Urobilinogen and White Blood Cells.
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    K Number
    K103387
    Device Name
    MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
    Manufacturer
    ACON LABORATORIES, INC.
    Date Cleared
    2011-02-02

    (76 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Product Code :

    JJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are assayed urine controls intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.
    Device Description
    The Mission Liquid Urine Control and Mission Liquid Diptube Urine Control are prepared from simulated human urine with purified chemicals, constituents of animal origin, preservatives and stabilizers. The controls are available in two levels, ready to use liquid format packaged in dropper bottles under the brand name Mission Liquid Urine Control and in diptube containers under the brand name Mission Liquid Diptube Urine Control. The results of the Mission Liquid Urine Control and Mission Liquid Diptube Urine Control are compared to the lot-specific expected values listed in the package insert to ensure the consistent performance of Mission Urinalysis Reagent Strips and Mission Urine Analyzers. The Mission Dry Strip Urine Control are firm plastic strips onto which reagent areas are affixed. The negative level strips have five reagent areas containing one or more synthetic ingredients. When placed in a measured quantity of distilled or deionized water, the ingredients dissolve out of the reagent areas to produce a Level 1 Control Solution. The Level 2 strips have six reagent areas affixed. The ingredients on the positive level strips dissolve out to produce a Level 2 Control Solution. The results of the Mission Dry Strip Urine Control are compared to the lot-specific expected values listed in the package insert to ensure the consistent performance of Mission Urinalysis Reagent Strips and Mission Urine Analyzers
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    K Number
    K081908
    Device Name
    CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2009-01-16

    (197 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Product Code :

    JJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest", and Ictotest This control is also intended to evaluate microscopic examination test procedures
    Device Description
    Not Found
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    K Number
    K072640
    Device Name
    IRISPEC,CA/CB/CC
    Manufacturer
    IRIS DIAGNOSTICS
    Date Cleared
    2007-12-21

    (94 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Product Code :

    JJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
    Device Description
    IRISpec™ CA/CB/CC controls are based on a synthetic matrix simulating human urine, with preservatives and bovine-sourced biological material for serum albumin, hemoglobin, bilirubin. No human sourced materials.
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    K Number
    K070848
    Device Name
    LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X
    Manufacturer
    BIO-RAD, DIAGNOSTICS GRP.
    Date Cleared
    2007-04-25

    (28 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Product Code :

    JJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.
    Device Description
    Liquichek Urinalysis Control is prepared from human urine with added human erythrocytes, simulated leukocytes, constituents of animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
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    K Number
    K052242
    Device Name
    ADVIA CHEMISTRY MICROALBUMIN CONTROLS
    Manufacturer
    BAYER HEALTHCARE LLC
    Date Cleared
    2005-10-03

    (47 days)

    Product Code
    JJW, JJY
    Regulation Number
    862.1660
    Why did this record match?
    Product Code :

    JJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method.
    Device Description
    The ADVIA® Chemistry Microalbumin Controls is a human urine based solution containing various constituents.
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    K Number
    K043266
    Device Name
    RANDOX URINE CONTROLS
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2005-02-15

    (81 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Product Code :

    JJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox Laboratories Ltd. Urine Controls are based on lyophilised human urine and have been developed for the control of both accuracy and precision in clinical chemistry applications particularly urine analysis. These control materials are available at two constituent concentrations. The Randox Assayed and Unassayed Urine Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
    Device Description
    Assayed and Unassayed Urine Controls based on lyophilised human urine.
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