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The Nova Allegro HbA1c Assay is intended for in vitro diagnostic use on the Nova Allegro Analyzer for the quantitative determination of the glycated Hemoglobin A1c) in capillary whole blood obtained from the fingertip. The results from this assay are intended to be used for the monitoring of long-term blood glucose/metabolic control in individuals with diabetes mellitus. The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

Nova Allegro Analyzer: The Nova Allegro Analyzer is a compact, point-of-care analyzer that features a clinically important menu of measured and calculated tests. All tests are measured with disposable, ready-to-use cartridges, and are easily performed by non-technical personnel. The analyzer supports multiple wavelengths that are used to measure the assay of interest. The analyzer consists of the following key systems/components that the user interacts with: Two analytical bays where the single use test cartridges are analyzed, Color Touchscreen Display, Barcode Scanner, Printer, Data Export Options, Ethernet Connection, USB Port. Nova Allegro HbA1c Assay: The Allegro HbA1c Assay is a completely automated assay for the HbA1c in human whole blood and the calculation of estimated average glucose (eAG). Nova Allegro HbA1c Test Cartridges are the key element a user interacts with to obtain the HbA1c concentration in a Capillary finger-stick whole blood sample. The main components of the Test Cartridge are the Capillary that is used to obtain the Capillary finger-stick whole blood specimen and present it to the Test Cartridge and the reaction chamber. The Test Cartridge has a barcode label with lot specific information.

The Nova Allegro urine albumin creatinine ratio (UACR) Assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy. The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

**Nova Allegro UACR Assay:** The Nova Allegro UACR Assay is a completely automated assay for the determination of albumin and creatinine in human urine. The results are used to calculate the UACR (Urine Albumin to Creatinine Ratio). Nova Allegro UACR Test Cartridges are the key element a user interacts with to determine the albumin and creatinine levels in a human urine sample. The main components of the Test Cartridge are the Capillary, the reaction chamber, and the barcode label. **Nova Allegro Analyzer:** The Nova Allegro Analyzer is a compact, point-of-care analyzer that features a clinically important menu of measured and calculated tests. All tests are measured with disposable, ready-to-use cartridges. The analyzer supports multiple wavelengths that are used to measure the assay of interest. The analyzer consists of the following key systems/components that the user interacts with: - Two analytical bays where the single use test cartridges are analyzed - Color Touchscreen Display - Barcode Scanner - Printer - Data Export Options - Ethernet Connection - USB Port

The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonatal heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonatal heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia. The StatStrip Glucose Hospital Meter System includes the following components: - StatStrip Glucose Hospital Meter - StatStrip Glucose Test Strips

StatStrip Glucose Hospital Meter System: The StatStrip Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated color touch-screen Graphical User Interface (GUI). StatStrip Glucose Test Strips: The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step provides a blood glucose result. Test strips will be sold in vials of 25 strips. StatStrip Glucose Control Solutions: The control solutions are aqueous assayed solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter. StatStrip Glucose Linearity Solutions: There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dve). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system. Charging (Docking) Station: The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed and charged wirelessly. The charging station should be located central to the patient care area being served by the meter (e.g., a nursing station). The data charging station must remain plugged in to a wall outlet for power. The system still allows the charging station to be used to transfer data from the meter to a central workstation and allow meter setup information to be downloaded from the central workstation to the meter.

The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Chloride, Ionized Calcium, Ionized Magnesium, Gucose, and Lactate in heparinized capillary whole blood. Indication for Use: pH, pCO2, pO2 measurements are used in the diagnosis and treatment of life-threatening acid base disturbances. Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal states, such as anemia and erythrocytosis. Glucose (Glu) measurement is used in the diagnosis and treatment of carbohydrate metabolism distuding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis. Sodium (Na) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance. Potassium (K) measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels. Chloride (Cl) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Ionized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

The Stat Profile Prime Plus Analyzer System is an analyzer for use in hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets). The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. Primary Sensor Card Port: There are two options for the primary sensor card: - Primary Sensor Card 1 shall enable and report the following listed analytes: . - PO2, PCO2, pH, Hct, tHb, SO2, O2Hb, COHb, MetHb, HHb, Glu, Lactate, Sodium, o Potassium, Chloride, Calcium, Ionized Magnesium - Primary Sensor Card 2 shall enable and report the following listed analytes: . - PO2, PCO2, pH, Hct, tHb, SO2, Glu, Lactate, Sodium, Chloride, Calcium, Ionized o Magnesium Auxiliarv Sensor Card Port: The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card - . Auxiliary Sensor Card 1 shall enable the Creatinine and BUN parameters - Auxiliary Sensor Card 2 shall be a "dummy" sensor card and will not report any parameters. . As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that ensures the analyzer is working properly. The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and capillary tubes. The sample size for analysis is 135 µL for the complete test panel or 90 µL for the capillary panel. Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel. Stat Profile Prime Plus Analyzer System Components: The Stat Profile Prime Plus Analyzer System is comprised of the following components. - . Stat Profile Prime Plus Analyzer System - Primary Sensor Cartridge . - Auxiliary Sensor Cartridge . - Stat Profile Prime Plus Auto-Cartridge Quality Control Pack - Stat Profile Prime Plus Calibrator Cartridge - Stat Profile Prime Plus External Ampule Control - . IFU/Labeling Sample Types: The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial, venous, and capillary whole blood. Measured Parameters: The Stat Profile Prime Plus Analyzer measures: - . pH - . Partial Pressure of Carbon Dioxide (pCO2) - Partial Pressure of Oxygen (pO2) ● - Hematocrit (Hct) ● - . Glucose (Glu) - . Lactate (Lac) - Sodium (Na) ● - Potassium (K) - Chloride (CI) - . Ionized Calcium (iCa) - . lonized Magnesium (iMg)

The Nova Primary Glucose Analyzer System is indicated for in vitro diagnostic use by healthcare professionals in clinical laboratory setting for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma. The measurement of Glucose is used in the diagnosis and treatment of carbohydrate metabolism distuding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The Nova Primary Glucose Analyzer System is a small, portable laboratory glucose analyzer that measures blood glucose levels in lithium heparinized whole blood or plasma utilizing a glucose oxidase based sensor and membrane/cap assembly. The Nova Primary Glucose Analyzer accepts samples from syringes, blood collection tubes, microcentrifuge tubes, and sample cups. The sample size for analysis is 25 microliters (aspirated volume). Nova Primary System Components: The Nova Primary Glucose Analyzer System is comprised of the following components. - Nova Primary Glucose Analyzer - Nova Primary Glucose Sensor - Nova Primary Glucose Membrane - Nova Primary Calibrator Cartridge - Optional Barcode Scanner - IFU/Labeling Sample Types: The Nova Primary Glucose Analyzer System accepts lithium heparinized venous whole blood and plasma.

The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Sodium, Potassium, Chloride, Ionized Calcium, and Ionized Magnesium in heparinized arterial and venous whole blood.

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets). The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times. The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL. Sample collection, preparation and application to the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets). The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times. The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL. Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood. Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis. Creatinine measurement is used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis. Blood Urea Nitrogen measurement is used in the diagnosis and treatment of certain renal and metabolic diseases.

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets). The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. Primary Sensor Card Port: There are two options for the primary sensor card: - Primary Sensor Card 1 shall enable and report the following listed analytes: o Glu. Lactate - Primary Sensor Card 2 shall enable and report the following listed analytes: o Glu, Lactate Auxiliary Sensor Card Port: The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card - Auxiliary Sensor Card 1 shall enable Creatinine and BUN parameters . - . Auxiliary Sensor Card 2 shall be a "dummy" sensor card, and will not report any parameters. As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times. The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL. Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel. Stat Profile Prime Plus Analyzer System Components: The Stat Profile Prime Plus Analyzer System is comprised of the following components. - Stat Profile Prime Plus Analyzer System . - Primary Sensor Cartridge . - Auxiliary Sensor Cartridge - Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ● - Stat Profile Prime Plus Calibrator Cartridge ● - Stat Profile Prime Plus External Ampuled Control . - . IFU/Labeling

The Stat Profile Prime Plus Analyzer System is intended for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, Partial Pressure of Carbon Dioxide (pCO2) and Partial Pressure of Oxygen (pO2) in heparinized arterial and venous whole blood. pH, pCO2 and pO2 Measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets). The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times. The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL. Sample collection, preparation and application to the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, Hematocrit, Ionized Calcium and Ionized Magnesium in heparinized venous whole blood, and pH. Ionized Calcium and Ionized Magnesium in plasma and serum. Ionized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety ofbone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). pH measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances. Hematocrit measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.

The Stat Profile Prime ES Comp Plus Analyzer is a small, low cost blood electrolyte analyzer. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets). The Stat Profile Prime ES Comp Plus Analyzer has an enhanced test menu and multiple quality control options. External Control Solutions (ampules) shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly. The Stat Profile Prime ES Comp Plus Analyzer can accommodate either of two sensor cards in the sensor card housing. The analyzer will determine the test configuration of the system by detecting which sensor card is installed. The two options for the sensor card are: - Sensor Card 1 (Basic Electrolyte Panel plus Hct) shall enable and report the following listed analytes: Hct, Na, K, Cl - Sensor Card 2(Full Electrolyte Panel plus pH & Hct) shall enable and report the following listed analytes: pH, Hct, Na, K, Cl, iCa, iMg As with the predicates, the Stat Profile Prime ES Comp Plus Analyzer is microprocessor-based and incorporates ion selective electrode technology to measure pH, ionized calcium, ionized magnesium. The Prime ES Comp Plus can be configured with an optional sample tray, which allows the user to run up to 10 consecutive samples may be any combination of Serum/Plasma or control solutions. Whole Blood samples may only be run in STAT Mode (not tray mode). Calibration standards are provided in sealed pouches within a calibrator pack. Liquid quality control materials are available as external ampules. Sampling and calibration are fully automated. The Stat Profile Prime ES Comp Plus Analyzer accepts lithium heparinized whole blood sample from syringes, open tubes, and small cups. The minimum sample sizes for analysis is 100 µL.