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The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure. The cartridge is to be used with the i-STAT 1 Analyzer bearing the (Immuno) symbol, but not with the i-STAT Portable Clinical Analyzer or the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the BNP test is to be used by trained health care professionals in accordance with a facility's policies and procedures. The i-STAT BNP Controls are assayed liquid plasma used to verify the integrity of newly received i-STAT BNP cartridges. The i-STAT BNP Calibration Verification Controls are assayed liquid plasma used to verify the calibration of i-STAT BNP cartridges throughout the reportable range.

The i-STAT BNP test is contained in a single-use test cartridge. In use, the user scans a bar code and then places approximately 17 uL of whole blood or plasma in the cartridge. After the cartridge is closed, it is inserted into the thermally controlled i-STAT 1 Analyzer, and all analytical steps are performed automatically. Patient and use information may be entered into the analyzer via a keypad during the automated analysis cycle. As the analyzer performs several quality checks and controls the temperature of the sensors via resistive heating to the underside of the sensor chips, the substrate/wash fluid is released into a conduit within the cartridge and a metered volume of the sample over the sensor chips. The enzyme-linked antibody conjugate dissolves into the sample incubates for a controlled time. The sample is then pushed into a waste chamber and the substrate/wash solution is brought over the sensors. The alkaline phosphatase captured on the BNP sensor cleaves the substrate present in the substrate/wash fluid, giving rise to an amperometric signal that is measured. The i-STAT BNP Controls are supplied in three levels packaged as six vials of one level per box with each vial containing 1 mL of control material. The three levels are in frozen liquid form, require no reconstitution or dilution, and are each comprised of a different level of BNP, a chemical synthetic peptide, prepared in human EDTA plasma and preserved with sodium azide. The first level of BNP is set at a typical diagnostic cutoff level while the second and third are set at higher levels spanning the range of the test. The BNP value will be provided in the value assignment sheet for each level. The i-STAT BNP Calibration Verification Control Set is packaged as a tri-level set comprised of two vials of each of three levels per box. The three levels in the BNP Calibration Verification Control Set are exactly the same materials as those used in the Level 1, Level 2, and Level 3 control products. The only difference between this product and the i-STAT BNP Controls is the number of vials and the number of levels that are packaged together.

The i-STAT CHEM8+ Cartridge is intended to be used by medical professionals for the quantitative measurement of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit in arterial, venous, and capillary blood. The i-STAT CHEM8+ Cartridge is useful for monitoring a variety of conditions. The panel of tests is used to assess kidney function, the hydration state, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

The modified device is the i-STAT CHEM8+ Cartridge. The modifications comprise a combination of several tests, all of which are on the market and reside in other i-STAT cartridges, into a new panel of tests. The new i-STAT CHEM8+ Cartridge contains a panel comprised of nine reported tests and two calculated tests as is indicated on the labeling for this device. Of these nine reported test, eight tests (glucose, ionized calcium, sodium, potassium, chloride, carbon dioxide, urea nitrogen and creatinine) are commonly referred to as a "basic metabolic panel". The two tests to be reported as calculated parameters are anion gap and hemoglobin. The i-STAT CHEM8+ Cartridge is a single-use device that is to be used with the i-STAT 1 Analyzer. As with other i-STAT Cartridges, two or three drops of venous, arterial or capillary blood is dispensed into the cartridge, the blood are sealed inside the cartridge with the snap closure, and the cartridge is then inserted into the analyzer. The analysis cycle is automatic and is controlled by software in the analyzer. Cartridges are calibrated at the factory. This cartridge is similar in design to the other i-STAT cartridges that are used for the same or similar in vitro diagnostic tests. The i-STAT CHEM8+ Cartridge is manufactured using the same process technology and equipment that is used for existing i-STAT cartridges.

The i-STAT CK-MB test is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis of myocardial infarction (MI). The cartridge is to be used with the i-STAT 1 Analyzer bearing the (Immuno) symbol, but not with the i-STAT Portable Clinical Analyzer or the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the CK-MB test is to be used by trained health care professionals in accordance with a facility's policies and procedures. The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in whole blood or plasma. Measurements on cardiac troponin I are used as an aid in the diagnosis and treatment of patients with acute myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

The i-STAT CK-MB test is contained in a single-use test cartridge. In use, the user scans a bar code and then places approximately 16 uL of whole blood or plasma in the cartridge. After the cartridge is closed, it is inserted into the thermally controlled i-STAT 1 Analyzer, and all analytical steps are performed automatically. Patient and use information may be entered into the analyzer via a keypad during the automated analysis cycle. As the analyzer performs several quality checks and controls the temperature of the sensors via resistive heating to the underside of the sensor chips, the substratelwash fluid is released into a conduit within the cartridge and a metered volume of the sample over the sensor chips. The enzyme-linked antibody conjugate dissolves into the sample and the sample incubates for a controlled time. The sample is then pushed into a waste chamber and the substrate/wash solution is brought over the sensors. The alkaline phosphatase captured on the CK-MB sensor cleaves the substrate present in the substrate/wash fluid, giving rise to an amperometric signal which is measured.

The i-STAT Cardiac Markers Controls are an assayed liquid serum used to verify the integrity of newly received i-STAT cTnl cartridges. The i-STAT Cardiac Markers Calibration Verification Controls are an assayed liquid serum used to verify the calibration of i-STAT cTnl cartridges throughout the reportable range.

The i-STAT Cardiac Markers Controls are supplied in three levels packaged as six vials of one level per box, with each vial containing 1 mL of control material. The three levels are each comprised of a different level of cardiac Troponin I, human creatinine kinase -- MB isoform CK-MB, and myoqlobin (all native forms) derived from human cardiac material, prepared in human serum, and preserved with sodium azide to inhibit microbial growth. The CK-MB and myoglobin are unassayed components in these materials. Only the cardiac troponin I (cTnl) values will be provided in the value assignment sheets for these products. The Cardiac Markers Calibration Control Set is packaged as a tri-level set, comprised of two vials of each of three levels per box.

The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoaqulation frequently associated with cardiovascular surgery. The test is to be used with the i-STAT Portable Clinical Analyzer (Models 200 and 300), but not the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the Kaolin ACT test is to be used by trained and certified health care professionals in accordance with a facility's policies and procedures.

The i-STAT Kaolin ACT test is contained in a single test cartridge. In use, approximately 40 microliters of fresh whole blood are placed in the cartridge is inserted into the thermally controlled i-STAT Model 200 or Model 300 Portable Clinical Analyzer, and all analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle. During the test the blood sample is mixed with reagents which are coated on the cartridge cover in a segment of the sensor channel. The reagent layer includes an activating agent, a thrombin substrate, and inert matrix components. These reagents allow activation of the coagulation cascade and detection of clot formation. In the i-STAT ACT test, the endpoint is indicated by the appearance of an electroactive marker generated by the thrombin-mediated conversion of a synthetic substrate included in the reagent. Detection of the marker indicates generation of thrombin and therefore complete activation of the coagulation cascade. The reported result is calculated from the time and rate of the substrate conversion and is given in seconds. The reported result correlates to the result of a traditional ACT in which the endpoint is indicated by physical clot formation.

The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-STAT 1 Analyzer, but not with the i-STAT Portable Clinical Analyzer or the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

The i-STAT cTnl test is contained in a single test cartridge. In use, the user scans a barcode and then places approximately 16 microliters of fresh whole blood in the cartridge is inserted into the thermally controlled i-STAT 1 Analyzer, and all analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle. As the analyzer performs several quality checks and controls the temperature of the sensors via resistive heating to the underside of the sensor chips, the substrate/wash fluid is released into a conduit within the cartridge and a metered volume of the sample over the sensor chips. The enzyme-linked antibody conjugate dissolves into the sample and the sample incubates for a controlled time. The sample is then pushed into a waste chamber and the substrate/wash solution is brought over the sensors. The alkaline phosphatase captured on the cTnl sensor cleaves the substrate present in the substrate/wash fluid, giving rise to an amperometric signal which is measured. The cTnl test cartridge is assembled from plastic components that provide the conduits for fluid handling and house the sensor chips. The test is identified to the user through the name and color code on the cartridge label and by the analyzer through features integral to the cartridge.

The i-STAT PT is a prothrombin time test cartridge and is an in vitro diagnostic test intended for quantitative prothrombin time testing for the monitoring of oral anticoagulation therapy using fresh venous or capillary whole blood samples. The i-STAT PT test is not intended for evaluating individual factor deficiencies. The cartridge is to be used with the i-STAT Portable Clinical Analyzer with thermal control (Models 200 and 300), but will not run on the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the PT test is to be used by trained and certified health care professionals in accordance with a facility's policies and procedures. The i-STAT PT, a prothrombin time test, is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.

The i-STAT PT test is contained in a single test cartridge. In use, approximately 40 microliters of fresh whole blood are placed in the cartridge as described below. The cartridge is inserted into the thermally controlled i-STAT Portable Clinical Analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle. In the i-STAT PT test the endpoint is indicated by the appearance of an electroactive marker generated by the thrombin-mediated conversion of a synthetic substrate included in the reagent. Detection of the marker indicates generation of thrombin and therefore complete activation of the coagulation cascade. The result is reported as an International Normalized Ratio (INR) and, optionally, in seconds. The optionally displayed seconds is intended to reflect a typical plasma prothrombin time. The PT test cartridge is assembled from plastic components that provide the conduits for fluid handling r no r r toot our negor chips. The coagulation test is identified to the user through the name and color code on the cartridge label and by the analyzer through features integral to the cartridge. During the test the blood sample is mixed with reagents which are coated on the cartridge cover in a segment of the sensor channel. The reagent layer includes tissue thromboplastin as an activating agent, the thrombin substrate, a heparin-neutralizing enzyme, and inert matrix components. These reagents allow activation of the coagulation cascade and detection of clot formation. Whole blood is introduced into the sample well of the cartridge at the sample port and the cartridge is closed and inserted into the analyzer. Insertion of the cartridge initiates a controlled and monitored sequence of steps in the instrument. These are: - Electrical contact is made between the analyzer electronic input circuits and the cartridge. . The analyzer identifies the type of cartridge being used and the tests contained in the cartridge. - The dry chips and sensor channel are heated to 37°C. . - The blood is then moved forward. Feedback from the fluid position sensor is used to allow . controlled oscillation of the blood segment resulting in dissolution of the reagent layer. - During the course of testing, the position of the blood segment is actively controlled to . maintain the length of the blood containing the reagent coincident with the endpoint detector. - Calculation of the sample clot time is performed and displayed. .