Profile: Prognostix, Inc. develops and markets next-generation cardiovascular disease diagnostic products. Our CardioMPO™ test aids in the diagnosis of near-term heart attack and cardiac death risk. It is an enzyme immunoassay intended for the quantitative determination of myeloperoxidase in human plasma, which is to be used in conjunction with clinical history, ECG and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction that will result in revascularization or death. Our CardioMPO™ assay is a sandwich enzyme-linked immunosorbent assay (ELISA) that uses two highly specific monoclonal antibodies, for the measurement of MPO concentration in human lithium heparin plasma. Our CardioMPO™ Assay is comprised of CardioMPO™ reagent kit, CardioMPO™ calibrator kit, and CardioMPO™ control kit.
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| • Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. |
| • Enzyme Immunoassay (EIA) Kits |
| • Immunoassay Myeloperoxidase Test System (FDA Code: NTV / 866.5600) A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases. |
| • Primary Calibrator (FDA Code: JIS / 862.1150) A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.) |
| • Reagent Assembly Kits |