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510(k) Data Aggregation

    K Number
    K090057
    Device Name
    ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    ACON LABORATORIES CO.
    Date Cleared
    2009-04-08

    (90 days)

    Product Code
    NBW, CGA, JJX
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACON LABORATORIES CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The On-Call® Plus Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in capillary whole blood from the fingertip, forearm, and/or palm by people with diabetes at home and by healthcare professionals as an aid in the monitoring the effectiveness of diabetes control programs. The On-Call® Plus Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. The On-Call® Plus Blood Glucose control solution is for use with the On-Call® Plus Blood Glucose meter and strips as a quality control check to verify the accuracy of blood glucose test results.
    Device Description
    The On-Call® Plus Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm, and/or forearm. The glucose, measurement is achieved by using the amperometric detection method. The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
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    K Number
    K061559
    Device Name
    ACON URINALYSIS REAGENT STRIPS
    Manufacturer
    ACON LABORATORIES CO.
    Date Cleared
    2006-08-11

    (67 days)

    Product Code
    CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMA, JMT, JRE, LJX
    Regulation Number
    862.1785
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACON LABORATORIES CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACON Urinalysis Reagent Strips (Urine) are for qualitative and semi-quantitative detection of one or more of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic Acid. The ACON Urinalysis Reagent Strips (Urine) are for single use in professional nearpatient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: - Kidney function . - Urinary track infections . - Carbohydrate metabolism (e.g. diabetes mellitus) . - Liver function . - Acid-base balance . - Urine concentration ● The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually. It is intended for professional use only.
    Device Description
    The ACON Urinalysis Reagent Strips are urine test strips of which Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte reagent pads are affixed onto the plastic strips. The reagent pads react with the urine and provide a visible color reaction. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. The product is packaged with a drying agent in a plastic bottle. The entire reagent strip is disposable when the disposal directions are followed exactly. Laboratory instrumentation is not required. These tests are intended for professional use with human urine.
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    K Number
    K023766
    Device Name
    ACON STREP A TWIST TEST DEVICE
    Manufacturer
    ACON LABORATORIES CO.
    Date Cleared
    2003-02-10

    (90 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACON LABORATORIES CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACON® Strep A Twist Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.
    Device Description
    The ACON® Strep A Twist Rapid Test Device is a qualitative, lateral flow immunochromatographic assay for the detection of Strep A antigen from a throat swab. The test is a heterogeneous, sandwich immunoassay, based on the principle of antigen-antibody immunochemistry, which uses a mixture of polyclonal antibodies to reliably produce a visually discernible colored line in the test region if Strep A antigen is present at a concentration of roughly 2.5 x 102 organisms per swab or greater.
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    K Number
    K020313
    Device Name
    ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
    Manufacturer
    ACON LABORATORIES CO.
    Date Cleared
    2002-05-08

    (98 days)

    Product Code
    DKZ, DIO, DJG, LAF, LCM, LDJ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACON LABORATORIES CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACON® One Step Multi-Drug Multi-Line Screen Test Card and Test Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of two to six drugs in a variety of combinations in human urine. The designated cut-off concentrations for these drugs are as follows: Amphetamine at 1,000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1,000 ng/ml, Opiates at 2,000 ng/ml, Marijuana at 50 ng/ml and Phencyclidine at 25 ng/ml. They are intended for healthcare professionals including professionals at the point of care sites.
    Device Description
    The ACON One Step Multi-Drug Multi-Line Screen Test Card and Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Amphetamine, Cocaine, Methamphetamine, Opiates, Marijuana, and Phencyclidine in urine samples. The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibodies to selectively detect elevated levels of Amphetamine, Methamphetamine, Cocaine, Opiates, THC and PCP in urine at the cut-off concentrations of 1,000 ng/ml (AMP), 1,000 ng/ml (mAMP), 300 ng/mL (COC), 2,000 ng/ml (OPI), 50 ng/ml (THC) and 25 ng/ml (PCP). These tests can be performed without the use of an instrument. A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing of Amphetamine, Cocaine, Methamphetamine, Opiates, Marijuana, and Phencyclidine at the concentrations below the designated cut-off levels will generate a colored-line in the designated test region for the drug. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
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    K Number
    K010582
    Device Name
    ACON STREP A RAPID TEST STRIP
    Manufacturer
    ACON LABORATORIES CO.
    Date Cleared
    2001-05-07

    (69 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACON LABORATORIES CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980736
    Device Name
    ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
    Manufacturer
    ACON LABORATORIES CO.
    Date Cleared
    1998-04-16

    (50 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACON LABORATORIES CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid qualitative chromatographic immunoassay for the detection of human chorionic gonadotropin in urine or serum. The ACON hCG Urine/Serum One Step Pregnancy Test is indicated for use as an aid in the early detection of pregnancy.
    Device Description
    The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).
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