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The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.

The Access Myoglobin assay is a sandwich immunoenzymatic assay. The Access Myoglobin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Myoglobin assay reagent pack, Access Myoglobin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

The CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction. The Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the rapid diagnosis of heart disease, for example, acute myocardial infarction. For in vitro diagnostic use. The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.

The AQT90 FLEX is a cartridge-based immunoassay analyzer, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample. This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups – no liquids other than the sample itself together with the assay buffer are required.

The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only. The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only. The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.

The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.

The ADVIA® Chemistry Myoglobin assay is for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease. The ADVIA Chemistry Myoglobin calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoglobin assay.

The Myoglobin reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Myoglobin calibrator is a single analyte, human serum based product containing myoglobin derived from human heart source. The kit consists of 1 vial each of 4 calibrator levels which are lyophilized. The target concentrations of these calibrators are 50, 100, 200, and 720 ng/mL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.

AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings. AQT90 FLEX Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction. AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer. AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.

The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample. This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.

Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.

The Elecsys Myoglobin Immunoassay includes two applications of the same reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.

Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems. Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.

The Access Myoglobin reagent and calibrators, the Access Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.

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.

ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the ARCHITECT i 2000SR System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI). ARCHITECT STAT Myoglobin is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of myoglobin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).

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Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes. ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy. The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods. ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay. Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease. The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers. The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer. The ABX PENTRA CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV test. The assay is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments. Reagents are chemical solutions with additives. The ABX PENTRA Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin. The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml. The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml. The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 ml. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml. The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.