LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K080823
    Device Name
    EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2008-11-17

    (238 days)

    Product Code
    JFJ,CDQ,CDT,CFR,KNK
    Regulation Number
    862.1070
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EasyRA amylase Reagent (AMY) is for the measurement of a-Amylase in serum using the "EasyRA chemistry analyzer". Amylase measurements are used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) and other pancreatic disorders. For in vitro diagnostic use only.

    The EasyRA Blood Urea Nitrogen (BUN) Reagent is for the measurement of urea in serum using the "EasyRA chemistry analyzer". Urea measurements in serum are used for the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use only.

    The EasyRA Glucose hexokinase (GLU-H) Reagent is for the measurement of glucose in serum using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. . For in vitro diagnostic use only.

    The EasyRA Triglyceride (TRIG) Reagent is for the measurement of triglycerides in serum using the "EasyRA chemistry analyzer". Triglyceride measurements are used in the diagnosis and treatment of diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders. For in vitro diagnostic use only.

    The EasyRA Uric Acid (URIC) Reagent is for the measurement of uric acid in serum using the "EasyRA chemistry analyzer". Uric Acid measurements are used in the diagnosis and treatment of renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. For in vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for several EasyRA reagents used with the EasyRA chemistry analyzer. It does not contain information about acceptance criteria, the study design, sample sizes, ground truth establishment, or expert qualifications for demonstrating device performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based solely on the provided text. The document confirms that the devices are substantially equivalent to legally marketed predicate devices, but it does not detail the specific performance studies that led to this determination.

    To answer your questions, I would need access to the actual 510(k) submission document (K080823) which would contain the performance summary.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1