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The Piccolo® Lactate Test System (presently contained on the MetLac 12 Panel Reagent Disc) used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate concentration in heparinized whole blood or heparinized plasma in a clinical laboratory setting or point-of-care location. Lactate measurements are used in the diagnosis and treatment of lactate acidosis, monitoring tissue hypoxia, and diagnosis of hyperlactatemia.

The Piccolo MetLac 12 Panel Reagent Disc (which contains the Piccolo Lactate Test System) is designed for lithium heparinized whole blood and lithium heparinized plasma. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

The RAPIDPoint 500 system is intended for in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters: - Partial pressure of carbon dioxide . - Partial pressure of oxygen . - . pH - Sodium . - Potassium . - lonized calcium . - Chloride . - Glucose . - Total hemoglobin and fractions: fO2Hb, fCOHb, fMetHb, fHHb . - Neonatal bilirubin . - . Lactate This test system is intended for use in point of care or laboratory settings. Lactate. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Lactate (Lac) is a new parameter offered on the RAPIDPoint 500 (RP500) blood gas system. The RP500 system is a point-of-care and laboratory testing blood gas analyzer and currently measures a variety of parameters that have been previously cleared. Enabling the lactate measurement is accomplished through software design changes introduced in Software Version 2.0 and requires the use of a RAPIDPoint 500 Measurement Cartridge. No hardware or mechanical changes were needed.

The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals for multiple patient use in a professional healthcare setting for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis. It is not for use on capillary blood specimens. It Is intended to provide plasma equivalent results to laboratory methods.

The Nova StatStrip Lactate Hospital Meter System has the same fundamental scientific technology and intended use as the currently marketed Nova StatStrip Lactate Hospital Meter System (K100602). Both the Nova StatStrip Lactate Hospital Meter System and the proposed Nova StatStrip Lactate Hospital Meter System are hand held devices with similar intended use to quantitatively measure the lactate levels in whole blood. The principle of operation is the same for the proposed and predicate device. Each utilizes a test strip that is inserted into a meter for results within 13 seconds.

The Lactate Acid Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, (3) diagnosis of hyperlactatemia. The Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.

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The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by health care professionals for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. It is intended to provide plasma equivalent results to laboratory methods. The Nova StatStrip Lactate Hospital Meter System is indicated for use in a clinical setting by healthcare professionals as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis. Nova StatStrip Lactate Test Strips are intended for use only with Nova StatStrip Lactate Hospital Meter for quantitative determination of lactate in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. The performance characteristics of the device for lactate measurements on capillary specimens have not been established. Nova StatStrip Lactate Test Strips are for testing outside the body (in vitro diagnostic use only). Nova StatStrip Lactate Control Solutions are intended for use with the Nova StatStrip Family of Meters and Nova StatStrip Lactate Test Strips as a quality control check to verify the accuracy of blood lactate test results. There are 2 levels of controls. (Level 1 and Level 2). Nova StatStrip Lactate Linearity Kit solutions are used to check the linearity of the Nova StatStrip Family of Meters. There are 4 levels of lactate linearity solutions: Level 1, Level 2, Level 3, and Level 4.

The Nova StatStrip Lactate Hospital Meter System consists of: 1. Nova StatStrip Lactate Hospital Meter 2. Nova StatStrip Lactate Test Strips 3. Nova StatStrip Lactate Control Solutions (Levels 1 and 2) 4. Nova StatStrip Lactate Linearity Solutions (Levels 1,2,3 and 4) 5. Meter Docking Station

The Lactate test, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions. Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

The epoc Lactate Test is being added as an additional sensor to the existing single use test card that is used with the epoc Blood Analysis System. This test card is inserted into the epoc Reader and all analytical steps are performed automatically. Patient and user information may be entered into the mobile computing device (epoc Host) during the automated analysis cycle. The epoc Blood Analysis System is an in vitro analytical system comprising a network of one or more epoc Readers designed to be used at the point of care (POC). The readers accept an epoc single use test card containing a group of sensors that perform diagnostic testing on whole blood. The blood test results are transmitted wirelessly to an epoc Host, which displays and stores the test results.

The lactate sensor is intended for professional and point of care use with the IRMA " Blood Analysis System for the direct measurement of lactate, in human whole blood. The Lactate Cartridge and the IRMA "Blood Analysis System are for in vitro diagnostic use. Lactate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

The IRMA" SL Blood Analysis System Lacrate Cartridge is for use with the IRMA "Blood Analysis System. The Lactate cartridge is a single use, disposable cartridge, for the in vitro measurement of lactate in whole blood. Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The lactate sensor uses an amperometric electrode along with a reference electrode that measures the lactate oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartidge is completed when information determined at the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry. Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

The Lactate Pro™ System is intended for the determination of Lactate in whole blood. The system is designed for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And evaluate physical performance or to establish a proper intensity of exercise for athletes. The system can be used in the clinical setting.

The Lactate Pro™ System consists of Lactate Pro™ Blood Lactate Test Meter, Lactate ProTM Test Strip.

The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood actifbase status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.

The i-STAT lactate test is contained in a single use cartridge. In use, two to three drops of blood are placed in the cartridge as described below. The cartridge is inserted into the thermally controlled i-STAT Model 200 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. The i-STAT System is an in vitro analytical system comprising a network of one or more portable clinical analyzers designed to be used at the point of patient care. The analyzers employ single-use test cartridges containing biosensor chips to perform diagnostic tests on whole blood. The system further comprises an infrared communications link from the analyzers to auxiliary information management devices such as printers, personal computers, laboratory information systems and hospital information systems. The i-STAT analyzers, as part of the i-STAT System, are intended for use by health-care professionals for the in vitro analysis of arterial, venous or capillary whole blood at the point of patient care. Tests with the i-STAT System are carried out in test cartridge. It houses the sensor array, aqueous calibrator, fluid channels, and a waste reservoir). Electrochemical sensors on biosensor chips are housed in cartridges in a variety of sensor test configurations appropriate to clinical needs. Test panels are identified by name and color code on the cartridge label. In addition, test panel configurations are encoded into the cartridge in a mechanical feature in the cartridge housing. An array of electrical pins in the analyzer recognizes the mechanical feature and automatically identifies the cartridge test panel type. In use, whole blood is introduced into the sample well of the cartridge at the sample port. After closure, the cartridge is inserted into the cartridge door of the analyzer. Insertion of the cartridge initiates a precisely controlled and monitored sequence of steps performed by the instrument without user intervention. These steps are: - Electrical contact is made between the analyzer electronic input circuits and the . The analyzer identifies the type of cartridge being used and the tests cartridge. contained in the cartridge. - Calibrator is positioned over the sensors. Each lactate test is calibrated with calibrator . fluid that contains a pre-determined amount of lactic acid. - Calibration measurements are made as the sensors generate signals mathematically . related to analytic concentrations. In the i-STAT lactate test the concentration of lactate is directly related to the appearance of hydrogen peroxide (measured by amperometrically) generated by lactic acid oxidase acting on lactic acid in the calibrator fluid or in the blood sample. - . Blood sample washes out the calibrator with the aid of an air bubble between the two. - . Blood sample is positioned over the sensors. - . Calculations of sample concentrations are performed and displayed. The displayed results are also stored in the analyzer memory and can be transmitted by infrared communication link to commercially available computers or printers. The lactate test cartridge is assembled from plastic components that provide the conduits for fluid handling and house the sensor chips. In the cartridge containing the test for lactate, the sensors comprise a patterned metallic layer, supported on a silicon/silicon dioxide substrate, coated with a thin membrane containing lactic acid oxidase.