Search Results

Lipid Controls: Assayed quality control materials for use with the Alere Cholestech LDX® system. Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System. Multianalyte Control: Assayed quality control materials for use with the Alere Cholestech LDX® system. Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System. Calibration Verification: Assayed calibration verification material is designed to be used for verifying the reportable range of tests on the Alere Cholestech LDX® System. This material is designed for use with any Alere Cholestech LDX® cassette type that includes total cholesterol, HDL cholesterol, triglycerides and glucose.

Assayed Quality Control materials and Assayed Calibration Verification materials for use with the Alere Cholestech LDX® system.

The INRatio/INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio/INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use). The INRatio2 PT Monitoring system is intended for professional and home use by people taking warfarin and other oral anticoaqulant (blood thinning) therapy who need to monitor the of their blood. The INRatio/INRatio2 PT Monitoring system is not intended to be used for screening purposes.

The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction occurs on the Test Strip.

The One Step EDDP (Methadone Metabolite) Test Strip is a rapid immunochromatographic assay for the qualitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine (EDDP), an inactive metabolite of methadone, at a designated cutoff concentration of 300 ng/mL. This product is used to obtain a visual, qualitative result and is intended for professional use and professionals at point of care sites. This assay provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The One Step EDDP (Methadone Metabolite) Test is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. EDDP, if present in the urine specimen below 300 ng/mL, will not saturate the binding sites of antibody-coated particles in the test. The antibody-coated particles will then be captured by immobilized EDDP conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the EDDP level exceeds 300 ng/mL because it will saturate all the binding sites of anti-EDDP antibodies. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region. This confirms sufficient specimen volume, adequate membrane wicking and correct

The Triage® Total 3 Controls are assayed controls to be used with the Triage® Troponin I Test. Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance. The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

The Triage® Total 3 Controls and the Triage® Total 3 Calibration Verification Set are quality control materials that contain CKMB, cardiac troponin I, and BNP at multiple concentrations. These materials are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage® tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient.

The Triage® CardioProfilER® Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of Creatine Kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), an aid in the risk stratification of patients with heart failure, and an aid in the risk stratification of patients with acute coronary syndromes. The Triage® Profiler S.O.B.TM (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peotide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.

The Triage CardioProfilER Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myoglobin, murine monoclonal and goat polyclonal antibodies against troponin I and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are builtin control features that ensure that the test was performed properly and the reagents were functionally active. The Triage Profiler S.O.B. Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myodlobin, murine monoclonal and qoat polyclonal antibodies against troponin I, murine monoclonal antibodies against D-dimer, and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that the test was performed properly and the reagents were functionally active. The Test Cartridges are inserted into the Triage Meter and results for each analyte are measured and displayed on the display screen or printout. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.

The Triage Total Controls 5 are assayed materials to be used with the Triage® Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to assist in monitoring test performance. The Triage Total Calibration Verification 5 materials are to be used with the Triage Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.

The Triage Total Controls 5 Control 1 and 2, and Triage Total Calibration Verification 5 Levels A, B, C, D, E are single-use, 0.29 mL unit dose quality control materials prepared with concentrated purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma at defined levels. The controls are stored frozen at < -20℃. Preservatives and stabilizers are added to maintain product integrity. The quality control materials are not calibrators and are not used to calibrate the Triage Test Devices.

The Triage Protein C Controls are assayed materials to be used with the Triage Protein C. Test to assist the laboratory in monitoring test performance. The Triage Protein C Calibration Verification Controls may be used by the laboratory to validate the performance of the Triage Protein C Test throughout the measurable range of the assay.

The Triage Protein C Control 1 and Control 2. and the Triage Protein C Calibration Verification Control Levels A, B and C are single-use, 0.25 mL unit dose liquid external quality control materials prepared with concentrated purified Protein C in human citrated plasma at defined levels. The controls are stored frozen at < -20°C. The liquid external quality control materials are not calibrators and are not used to calibrate the Triage Protein C Test.

The Triage® Protein C Test is a rapid, point-of-care fluorescence immunoassay to be used with the Triage Meters for the rapid, quantitative determination of Protein C in citrated whole blood or plasma specimens in patients with signs and symptoms of sepsis. The test is not intended for use in patients with vitamin K deficiency, DIC, cancers, HIV and liver and renal diseases as these disease conditions have not been evaluated.

The Triage Protein C Test is a single-use device containing murine monoclonal antibodies against Protein C labeled with a fluorescent dye and purified Protein C antigen immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that ensure that the test was performed properly and the reagents were functionally active. The Test Cartridge is inserted into the Triage Meter and results are measured and displayed on the display screen or printout in approximately 15 minutes. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only preliminary test results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.

The Triage TOX Drug Screen Methadone assay is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of methadone in urine. The Triage Methadone assay is identical in principle, reagents and procedure to the previously cleared Triage TOX Drug Screen (FDA file number K043242). The only difference between the two tests is that an assay for methadone has been added.