Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K022538
    Device Name
    IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
    Manufacturer
    DIAGNOSTIC CHEMICALS, LTD. (USA)
    Date Cleared
    2002-08-23

    (22 days)

    Product Code
    JIR
    Regulation Number
    862.1645
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC CHEMICALS, LTD. (USA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For IN VITRO diagnostic use. There are several kidney disease conditions that can produce high levels of albumin in urine (1). Determining albumin in the urine at the low levels measured by this test is helpful for early detection and treatment of patients at risk for renal (kidney) disease. Low but elevated urinary albumin levels, or microalbuminuria, refers to a level of the human protein albumin in urine above about 18 mg/L. Levels above 18 mg/L are not normally found in healthy individuals. These low but significant levels are not detectable with older dipstick assays. The ImmunoDip™ Urinary Albumin Test classifies samples as positive based on their being above or below a level of 18 mg/L. Conditions in which elevated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-8); hypertension (9, 10); and renal disease found in pregnancy (11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics develop serious kidney disease (3). Testing for elevated levels of albumin in urine helps to identify those diabetics who are prone to kidney disease. Scientific studies indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1, 9).
    Device Description
    Not Found
    Ask a Question
    K Number
    K974874
    Device Name
    BILIRUBIN-SL (TOTAL) ASSAY
    Manufacturer
    DIAGNOSTIC CHEMICALS, LTD. (USA)
    Date Cleared
    1998-02-12

    (45 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC CHEMICALS, LTD. (USA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of Total Bilirubin in serum. For IN VITRO diagnostic use.
    Device Description
    Traditional methods of measuring bilirubin are based on the reaction of bilirubin with a diazo reagent to form the colored compound: azo-bilirubin. The diazo reaction can be accelerated by the addition of various chemicals. For example, Malloy-Evelyn (1) used ethanol, Jendrassik-Grof (2) used caffeine, and Walters-Gerarde (3) used DMSO. Modifications of these methods included the addition of surfactants as solubilizing agents (4). In this method, a 2,4-dichlorophenyl diazonium salt is used as the diazo reagent and the reaction is facilitated by the use of a surfactant.
    Ask a Question

    Page 1 of 1