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The LeadCare® Plus™ Blood Lead Testing System is intended for the quantitative measurement of lead in a whole blood sample. The LeadCare Plus Blood Lead Testing System is intended for in vitro (external) use only. The test kit components are for use with both the LeadCare Plus and LeadCare Ultra® Blood Lead Testing Systems. This test system is for prescription use only. This system is not intended for point of care use.

The LeadCare Plus Blood Lead Testing System is a new instrument to the LeadCare line of instruments. The predicate, LeadCare Ultra, is a 6-channel analyzer which has the same intended use as the LeadCare Plus. The LeadCare Plus instrument is a one-channel version of this system. The LeadCare Plus Analyzer is used in conjunction with the same test kit components, including: sensors, control materials, and single-use packaged reagent tubes as utilized with the predicate device, LeadCare Ultra. The single-channel LeadCare Plus analyzer is an in vitro diagnostic device that relies on electrochemistry (Anodic Stripping Voltammetry or ASV). The analyzer is a low voltage potentiostat that runs on AC power or batteries and has dimensions of 9"x6.5"x3.5". It is equipped with a Liquid Crystal Display (LCD) Screen, Sensor Connector and Calibration Button reader. The Screen displays instructions for the blood lead assay, result, lot code and error messages. The Calibration Button reader allows for the download of all calibration information, analytical test parameters, and lot code information for any given Sensor lot. For measurement of lead, the whole blood sample is pipetted to a packaged reagent tube. Upon mixing, the red blood cells are ruptured and the lead is released from the proteins and becomes labile and available for electrochemical detection. After the sample mixture is applied to the sensor, the analyzer applies an electrical potential that causes the lead to reduce (collect) on the sensor. After three minutes, the analyzer applies potentials that cause the lead to oxidize back into solution. The current produced is measured and the amount of lead in the sample is calculated. The analytical result is displayed on the screen in micrograms per deciliter (ug/dL).

The LeadCare® Ultra™ Blood Lead Testing System is designed to quantitatively measure the amount of lead in a whole blood sample. The LeadCare® Ultra™ Blood Lead Testing System is intended for in vitro (external) use only. The test kit components are designed for use only with the LeadCare® Ultra™ Blood Lead Testing System. This test system is for prescription use only. This system is not intended for point of care use.

The LeadCare Ultra System Blood Lead Testing System is an in vitro diagnostic device that relies on electrochemistry (Anodic Stripping Voltammetry or ASV) and a unique sensor to detect lead in whole blood. Most lead is carried within red blood cells. When a sample of whole blood is mixed with Treatment Reagent (a dilute solution of hydrochloric acid), the red blood cells are lysed and the lead becomes available for detection. When a test is run, the Analyzer applies an electrical potential that causes the lead to collect on the Sensor. After three minutes, the Analyzer measures the amount of lead on the Sensor and displays the result in micrograms per deciliter (ug/dL). The multi-channel LeadCare Ultra Analyzer performs up to six blood lead tests simultaneously and uploads the completed test results to the Computer. Test results are stored in the Computer in unique sample records, along with sample ID, comments, test conditions, Sensor lot number, and user ID. The Analyzer is also equipped with a Calibration Button Reader. This Reader allows for the download of all calibration information, analytical test parameters, and date code information for any given Sensor lot. These actions can be accomplished by simply touching the appropriate Calibration Button to the Reader. The system's Computer is dedicated to running only blood lead analyses, and sits on a stand directly behind the monitor. The Computer serves as the user interface for entering patient ID information using a keyboard or barcode reader. It also performs data analysis after blood lead measurements are processed by the firmware embedded in the Analyzer. The Computer stores the patient results (and allows for retrieval of stored results) and it allows connectivity via USB ports to a customer-supplied printer and Laboratory Information Management System (LIMS). Peripherals for the computer are a monitor, keyboard, barcode reader and mouse. The analyzer is used in conjunction with a LeadCare Ultra Blood Lead Test Kit.

For In Vitro Diagnostic Use Only. The LeadCare® II Blood Lead Testing System is an instrumented assay to be used in the quantitation of lead in human whole blood. The Leadcare® II System is suitable for use in a physician's office laboratory environment (POL).

The LeadCare® II Blood Lead Testing System is an instrumented assay utilizing electrochemistry and a unique sensor to be used for the quantitation of lead in whole human blood. Testing can be performed on venous or capillary samples. The system is comprised of an analyzer, sensor (single use, disposable), reagent vial (filled with a measured amount of Treatment Reagent) and a calibration button. The system is powered by 4 AA batteries or AC Adapter. A built in self test checks the electronic functions of the analyzer cach time it is turned on. Blood lead controls are available to monitor the precision and accuracy of the system. The methodology of the system is Anodic Stripping Voltammetry (ASV). Most lead is carried in red blood cells. When a sample of whole blood is mixed with Treatment Reagent, the lead in the red blood cells is released and made available for detection. During the Pb test, the analyzer causes the lead to collect on the sensor. After a specified time, the analyzer removes the lead accumulated on the sensor. The current response (a peak shaped curve) is baseline corrected, quantified and converted to a blood Pb value. The analyzer displays the blood Pb level in units of µg/dL. The test electrode is covered by a thin layer of colloidal gold in an inert polymer matrix. The treatment reagent contains a dilute hydrochloric acid solution in water.

The LEADCARE™ Blood Lead Testing System is an instrumented assay to be used in the quantitation of lead in human whole blood. The LEADCARE System is suitable for use in a physician office laboratory environment (POL).

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