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510(k) Data Aggregation

    K Number
    K162471
    Device Name
    Hach CM130 Chlorine Monitoring System
    Manufacturer
    HACH COMPANY
    Date Cleared
    2017-03-30

    (205 days)

    Product Code
    PSX, FIP
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    HACH COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hach CM130 is an instrument that is intended for use by hemodialysis professionals to automatically monitor low levels of total chlorine (i.e. total chloramines plus free chlorine) in feed water used to prepare dialysate in hemodialysis systems. The CM130 is a component of the complete water treatment system for hemodialysis and does not treat or alter the water used in dialysate. The CM130 instrument's automated monitoring records total chlorine values in feed water at intervals between 5 and 20 minutes.
    Device Description
    The Hach CM130 Chlorine Monitor is a microprocessor-controlled analyzer used to monitor the chlorine content of water which is used to prepare dialysate for hemodialysis. The monitor is mounted in the water room in a location that allows sampling of feed water between the primary (scrubbing) and secondary (polishing) carbon tanks. Water that flows into the CM130 exits the device to a drain. The water samples, once tested, are also discarded to a drain. The monitor measures and displays total chlorine (free chlorine and combined chloramines) as Cl2, ranging from 0.03 to 0.20 mg/L. The CM130 Chlorine Monitor employs a DPD Colorimetric Method for the detection of total chlorine. The analyzer introduces N,N-Diethyl-p-phenylenediamine (DPD) indicator with potassium iodide and a buffer to the water sample under test. The indicator and buffer are allowed to react with the chlorine and chloramines present in the water. The reaction results in a dye which forms a red color in the water sample. The intensity of the red color is proportional to the total chlorine concentration. It is measured photometrically and the results are automatically recorded and displayed. The Remote Indicator (RI) is a subsystem that is mounted in the patient treatment area, typically near the ceiling, so that it can be easily seen. Its primary function is to communicate the status of the chlorine concentration of the feed water and the status of the analyzer to the staff while they are working in the patient treatment room. The CM130 Chlorine Monitor and the Remote Indicator will each provide both an audible and a visual signal.
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    K Number
    K070419
    Device Name
    OPACIDEN OPA REAGENT STRIPS
    Manufacturer
    HACH COMPANY
    Date Cleared
    2007-08-31

    (199 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    HACH COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Opaciden OPA Solution Test Strips are a concentration monitor dedicated for use in The Opaciden Of A Solition Tool Derpo de oblions with a minimum recommended ortho-pintlanadeliyate-containing genixo. A Solution Test Strips are dedicated for use with the Ciden Opaciden OPA Solution.
    Device Description
    The Opaciden OPA Solution Test Strip is a white polystyrene strip. of dimension 3.25 by 0.2 inch, with a 0.2 by 0.2 inch square yellow indicator pad at one end. It is intended for use exclusively with Opaciden OPA Germicide solutions to determine the germicide concentrations. The reagent pad is immersed in the sample and removed after 2 seconds. Excess sample is shaken off the pad and the strip is kept horizontal for 60 seconds. The chemical reagents in the indicator pad causes the pad to change color from yellow to magenta in OPA solutions with an ortho-phthalaldehyde concentration greater than the MRC of 0.3% OPA.
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    K Number
    K042322
    Device Name
    STERICHEK BLOOD LEAK REAGENT STRIPS
    Manufacturer
    HACH COMPANY
    Date Cleared
    2004-12-07

    (103 days)

    Product Code
    FJD
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    HACH COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek® Blood Leak Reagent Strips provide a quick convenient means of testing for occult blood in dialysate. SteriChek® Blood Leak Reagent Strips provide a quick convenient means of checking the presence of Blood in dialysate to assist in confirming an alarm by the blood leak monitor of the Hemodialysis machine.
    Device Description
    The device is made up of a 0.20 inch square yellow reagent pad that has been chemically treated to detect the presence of blood in the dialysate solution used in Hemodialysis. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. To use the reagent strip, the reagent pad is immersed in the sample, removed immediately and allowed to react for 60 seconds. The reagent pad is then compared with the color blocks on the bottle label. The Negative color block is yellow with small blue-green speckles. If a reagent pad has a similar yellow color 60 seconds after reaction with dialysate, then the dialysate does not contain significant blood. The Positive color block is green. A reagent pad with color equal to or darker than the Positive color block indicates the presence of significant blood leak. The speckles on the color blocks represent the reaction image that might be left by intact red blood cells that might land on the reagent pad.
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    K Number
    K040660
    Device Name
    STERICHEK GLUTARALDEHYDE REAGENT STRIPS
    Manufacturer
    HACH COMPANY
    Date Cleared
    2004-11-15

    (248 days)

    Product Code
    LIF
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    HACH COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek® Glutaraldehyde Reagent Strips provide a convenient means of testing the concentration of Glutaraldehyde in dialyzer disinfecting solutions. The test is not intended to replace microbiological tests or quantitative determinations of concentrations of stock solutions of Glutaraldehyde. The test may be used on a random sample of reprocessed dialyzers in order to document the presence of the agent during storage. SteriChek® Glutaraldehyde Reagent Strips do not measure residual levels of Glutaraldehyde
    Device Description
    The device is made up of a 0.20 inch square light red reagent pad that has been chemically treated to test the concentration of Glutaraldehyde in solutions for disinfecting dialyzers used in Hemodialysis. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
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