Use of the nova statstrip blood glucose meter clinical. The statstrip glucose hospital meter is a handheld testing device that works in conjunction with nova statstrip glucose test strips to measure glucose in a whole blood sample. Poct nova statstrip meter trougleshooting guide version. Hospital meter and nova statstrip glucose test strips as a quality control check to verify the accuracy. Nova statstrip glucose meter data sciences international. Correction for hematocrit, ascorbic acid, acetaminophen, uric acid, maltose, galactose, and oxygen. The device is a handheld, batteryoperated meter that uses a modified glucoseoxidasebased amperometric technology with hematocrit correction.
Fda clears first glucose meter for critically ill patients. Standard operating procedure for nova stat strip connectivity blood glucose meters for use in leeds nhs trust this standard operating procedure explains the protocol for measuring blood glucose concentration using the nova stat strip connectivity meters, with emphasis placed on the responsibility of nursing staffhcas to ensure that the. Statstrip glucose meter rapidly becoming standard in accurate hospital glucose testing throughout usa and now canada. Statstrip is intended for the measurement of pglucose in fresh a guide from the statstrip manual is reprinted in attachment 1. Statstrip meter first introduced in may 2006, by nova biomedical. Nova biomedical corporation khushboo surendran 200 prospect street waltham, ma 02454 re. Evaluation of the nova biomedical statstrip glucose meter barbara mohn, chemical pathology, middlemore hospital, auckland abstract aims. Department of pathology and laboratory medicine capital. This standard operating procedure explains the protocol for measuring blood glucose concentration using the nova stat strip connectivity meters, with emphasis placed on the. The nova statstrip lactate hospital meter system consists of.
Pdf an evaluation of the analytical performance of a new. Meter must be placed in docking station when not in use a. The nova stat strip glucose meter reads results between 10600 mgdl a result reading higher than 600 will read as hi a result reading lower than 10 will read as lo any outofrange result will be displayed in red results within normal range 65115 will be displayed in blue. Nova biomedical part numbers 43370 41741 41743 43607 41741 41741 41743 41741 41743 41743 41743 42215 41743 43607 41741 41743 41743 41741 35284 41741 41743 37274 37273 35283 15864. Food and drug administration for use in neonatal testing.
Nova statstrip control solutions is intended for use with the nova statstrip glucose hospital meter and nova statstrip glucose test. Statstrip cleared for capillary testing with critically. Clia waived for use with arterial, venous, and capillary samples from critically ill. Nova statstrip custom test strips for winthrop hospital 100bx. Nova statstrip lactate control solutions levels 1 and 2 4. Contain a desiccant to protect against humidity must be closedwith its lid when not in use store at room temperature between 15 to 40 degrees centigrade 59 to 104 degrees fahrenheit when opening a new vial of strips, write on vial. Statstrip and statstrip xpress2 glucose metersonly. Pdf the andres clamp technique, which requires accurate and timely.
Nova biomedical 200 prospect street waltham, ma 024549141 u. Evaluation of the nova biomedical statstrip glucose meter. En6060112 electromagnetic compatibility medical electrical equipment. Nova statstrip glucose bibliography nova biomedical. Pdf accuracy and reliability of the nova statstripr glucose. Nova statstrip xpress glucose hospital meter instructions. The statstrip glucoseketone hospital meter system offers bidirectional wireless connectivity to hospital his or lis with complete security to protect patient data. Poct glucose testing using nova statstrip meter procedure version.
Statstrip lactate is a very lowcost device that makes lactate testing practical and affordable in any size ed, icu, or medical unit. John mchale vp of raqa and technical support regulation. The fda granted this 510k clearance to statstrip after extensive prospective and retrospective studies were performed. Nova connects, an easy to use total system for point of care represents the many connectivity options for nova biomedical products, like managment of poc operators, data capturing, reporting and statstrip. Direct comparison of the istat and statstrip creatinine methods with different sample types. Which pointofcare creatinine analyser for radiology. This certifies that this product was manufactured and tested at nova biomedical corporation, waltham ma 02453 u. Toxicological information local effects skin contact. We evaluated the analytical performance and clinical reliability of a newgeneration glucose monitoring system statstrip.
The fda approved the nova statstrip glucose hospital meter system for use among all hospitalized patients on september 24, 2014. Two levels of quality control testing must take place. The nova statstrip glucose meter was evaluated for accuracy, reliability, and. Interfering substances such as hematocrit, drugs, and elevation of pathophysiological and other endogenous metabolites have all been shown to interfere with the measurement of glucose testing in handheld glucose meters. A nova clinical specialist helped the facility identify this problem. Statstrip glucose hospital meter system receives fda clearance for capillary testing with critically ill. The need for an accurate and fast method for the determination of pg levels during a clamp study has led us to test the nova statstrip glucose monitor nova biomedical, waltham, ma. Any paper document labeled uncontrolled must be verified against the. The nova statstrip pointofcare glucose monitor enables bedside glucose testing with analytical performance that approaches the quality of central laboratory testing. Date opened and date expired expiration date is 180 days from opening or label expiration. Nova thanks you for choosing the nova max blood glucose monitor. Nova biomedical statprofile pilox plus l k023567, k012058 analyzer description of the device.
Nova biomedical develops, manufactures, and sells advanced. View online or download nova biomedical statstrip quick reference manual. Statstrip lactate specifications other nova biomedical. Nova stata strip glucose meter training cape fear valley. Hl7 interface for nova biomedical glucose meters adl. Nova biomedical is the world technology leader in the development of fast whole blood analyzers to support the care of critically ill patients. Nova statstrip glucose hospital meter system approved for. Statstrip is manufactured by nova biomedical corporation, usa. Statstrip glucose ketone poct monitoring system by nova. New stat strip glucose meter and strips chosen for province wide implementation.
Glucose testing using nova statstrip meter operating procedure. Nova statstrip glucose linearity kit ref number 42173 lot. Nova statstrip glucose bibliography pointofcare glucose testing can be a challenge in the hospital setting. All of the batteries are supplied through nova biomedical, however, they are manufactured by formosa electronic industries, inc. The nova statstrip glucose linearity solutionused to check the linearity of the nova statstrip s are xpress 2 glucose hospital meter. The nova statstrip system is intended for in vitro diagnostic use by health care professionals for the quantitative measurement of glucose and ketone in fresh capillary, venous, arterial, whole blood samples. Nova s new statstrip glucose monitor has received clearance from the u. Nova statstrip lactate pointofcare measuring system roducts. The fda has granted 510k clearance for the first fingerstick capillary testing meter for critically ill patients with diabetes, nova biomedical announced in a press release. July 12, 2018 nova biomedical corporation john mchale vp.
Since many years nova biomedical is a trusted partner of tecom analytical systems with a long history in developing and producing the world most advanced and innovative analyzers, nova biomedical is one of our suppliers for many years. October 2018 nova biomedical s statstrip glucose hospital meter system has been cleared by the fda for fingerstick capillary testing with critically ill patients. Please be aware that staff require update training every 2 years for this medical device. Safety data sheet statstrip glucose control, level 1 ref 41741 page 3 11. Qc is performed within 24 hours prior to a patient test. Nova biomedical conducted a large multicenter study of the statstrip glucose hospital meter system at. These studies were conducted at some of the most prestigious hospitals and diabetes centers in the world, and prove that nova biomedicals statstrip glucose. Any paper document labeled uncontrolled must be verified against the electronic version prior. Glucose strips statstrip ketone strips statstrip hospital. Severe hematocrit abnormalities are routinely found in. Statstrip glucose hospital meter system 510k premarket notification, july, 2018. Nova biomedical corporation, waltham, ma 024549141.
Statstrip lactate provides the fastest turnaround time possible seconds, on the smallest whole blood sample 0. Statstrip and statstrip xpress 2 glucose meters statstrip glucose hospital meter system receives fda clearance for capillary testing with critically ill patients only glucose meters with fda clearance for use with all patients including critically ill. Nova statstrip glucose test strips are for testing outside the body in vitro diagnostic use only. Statstrip glucose meter page 2 of 6 mean arterial pressure of nova statstrip glucose meter. The nova max blood glucose monitor is designed to be convenient and easy to use. Nova statstrip system is specifically indicated for use in a. This owners guide contains important information on the monitor and how it works.
Nova connects, an easy to use total system for point of care represents the many connectivity options for nova biomedical products, like. Nova biomedical launches cemarked statstrip lactate, hemoglobin, and hematocrit pointofcare meter system nova biomedical announces the launch of both the statstrip and statstrip xpress2 lactate, hemoglobin, and hematocrit meter systems in all ce regulated countries. We investigated total imprecision, inaccuracy, and analytical range limits by measuring glucose in 481 plasma samples of diabetic patients. Nova statstrip glucose analyzer receives fda clearance for neonatal testing. Statstrip lactate provides lab equivalent accuracy from small. It was also compared against three other meters and two reference methods. Designed for applications that do not need data interfacing and connectivity, xpress creatinine retains all of the analytical performance features of statstrip creatinine test strips. The statstrip glucoseketone monitoring system features a patented. Lactate is currently measured on blood gas analysers which creates numerous problems for bedside testing. The nova statstrip xpress glucose hospital meter is a handheld, batterypowered, in vitro diagnostic laboratory instrument that works in conjunction with nova biomedical glucose electrochemical test strips to measure glucose in a whole blood sample, a quality control qc solution, linearity, or proficiency solutions.
If your barcode is not working, it is likely you are due a training. It is the preferred reference for calibration of continuous glucose telemetry. Compared to any competitive alternative, nova analyzers have the most extensive stat test menus and deliver these tests in the shortest time at the lowest costs. The nova statstrip blood glucose monitoring system was evaluated for precision, accuracy, and interferences from haematocrit and maltose. Please read it carefully before using your new monitor. Statstrip s 6second analysis time, color touch screen operation, and simple operating steps make bedside glucose testing fast. Use of the nova statstrip blood glucose meter clinical guideline v3.
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