StatStrip® Glucose Hospital Meter System
Only BGMS FDA-cleared for use with ALL patients, including critically ill


Read the FDA’s press release here

Read Nova’s press release here

New Intended Use for All Patients, Including Critically Ill

In 2014, after an extensive, nearly four-year project with the U.S. Food and Drug Administration (FDA) and five major university medical centers, Nova Biomedical achieved a major breakthrough in intended use for the StatStrip Glucose Hospital Meter System (StatStrip). In response to Nova’s 510(k) submission (K132121), the FDA cleared StatStrip for use throughout all professional healthcare settings including critical care.
“This device [StatStrip] provides an important public health resource for critically ill hospitalized patients, who often have conditions or are taking medications that can cause incorrect blood glucose reading. It is important for manufacturers of glucose meters used in hospitals to design and test their devices for use in all hospitalized patients.”1

- Alberto Gutierrez
Director of the Office of In Vitro Diagnostics and Radiological Devices
Center for Devices and Radiological Health, FDA

ONLY BGMS cleared by the FDA for use with all patients, in all professional healthcare settings, including critical care
  • Saves providers the time and labor of validating another BGMS with critically ill patients
ONLY BGMS that is CLIA-waived for use with all patients
      • Providers do not need to meet requirements to perform high complexity testing
      • Nursing and point-of-care (POC) operators can perform testing with all patients
Excellent correlation to IDMS traceable laboratory methods ONLY BGMS proven to have no known clinically significant interferences
      • Tested over 8,000 medications in complex treatment regimens
Accuracy proven in FDA study of 1,698 critically ill patients with over 257 clinical conditions
      • Improved accuracy results in better outcomes for critically ill patients
ONLY BGMS specifically designed for hospital use

Nova StatStrip Glucose Hospital Meter System – Capillary Specimen Usage

The Nova StatStrip Glucose Hospital Meter System (StatStrip) is the only glucose analyzer cleared by the FDA for use in all types of hospital patients, including critically ill patients receiving intensive medical intervention. For healthcare settings other than critical care, StatStrip is cleared for use with capillary finger stick, arterial, venous, neonatal heel stick and neonatal arterial specimens. When using the system to measure glucose on critically ill patients, StatStrip is cleared for use with arterial, venous, neonatal heel stick and neonatal arterial specimens. It is not cleared for use for capillary specimens on critically ill patients. Some critically ill patients present challenges when attempting to collect a representative capillary blood sample at the fingertip because they have insufficient peripheral blood flow due to dehydration, shock or the use of certain medications. The sample may also be diluted with interstitial fluid and may not represent the true physiological blood glucose concentration. This has led many hospitals to only use arterial or venous specimens in this specific patient population. StatStrip is the only POC whole blood glucose measurement system cleared by the FDA to provide venous, arterial, neonatal heel stick and neonatal arterial results for critically ill patients receiving intensive medical intervention. Data in support of this clearance covered 1,698 patients in all critical care areas of the hospital who were suffering from a wide range of medical conditions and complex drug and therapeutic regimens. The StatStrip whole blood glucose results showed excellent agreement compared to IDMS traceable laboratory glucose analyzer methods in all critical care patient types presented. Nova Biomedical did not present capillary data to the FDA due to the uncertainty of obtaining a valid capillary blood sample from a patient with compromised peripheral perfusion. However, Nova is currently working with the FDA and leading healthcare providers to identify those critically ill patients for whom capillary finger stick testing may be appropriate. It is important to note that no blood glucose analyzer is cleared for capillary finger stick testing of glucose in critically ill patients. StatStrip is cleared for testing in venous, arterial, neonatal heel stick and neonatal arterial blood samples from critically ill patients. No other blood glucose analyzer is specifically cleared for testing of any sample type from critically ill patients.

Use of Any Other BGMS with Critically ill Patients Is Off-Label

StatStrip is FDA-cleared and CLIA-waived for use throughout all hospital and all professional healthcare settings including critical care. Use of any other cleared, strip-based BGMS with critically ill patients is considered “off-label” by the FDA and CMS and “high complexity testing” under CLIA. The personnel testing requirements for off-label use are very demanding and limit who can use the device. In addition, a hospital must conduct comprehensive testing to prove the off-label use of the device is safe and effective over the range of complex medical conditions found in critically ill patients and intensive care units. In order to help hospitals avoid the risk of glucose meter off-label use, Nova Biomedical’s technical support resources are ready to help you acquire the StatStrip Glucose Hospital Meter System. To learn more about how StatStrip Glucose can bring critical care testing to the bedside, contact your current GPO, call Nova at 800-458-5813, or fill out the form below: [contact-form-7 id="4264" title="FDA"]

Why the Need for FDA Clearance for Critical Care?

In the last several years an unacceptably high number of adverse patient events and deaths have been traced to the use of glucose meters in hospitals in the U.S. Increasingly, the FDA has recognized and acted upon the need for more accuracy and better performance standards for POC glucose testing in hospitals, particularly in critical care settings. July 2009: FDA issues warning letter regarding patient deaths due to interferences with BGMS using GDH-PQQ. March 2010: At an FDA open forum, patients, providers, manufacturers, and regulators identify the need for stricter accuracy standards for hospital BGMS. May 2013: FDA issues second warning regarding deaths due to interferences with BGMS used with hospitalized patients. January 2014: FDA releases draft guidance that defines new testing and performance requirements for hospital BGMS and for non-hospital self-monitoring of blood glucose (SMGB) devices, stating:
      • “Patients in professional healthcare settings can be acutely ill and medically fragile and are more likely to present physiological and pathological factors that could interfere with glucose measurements as compared to the lay population.”
      • “Errors in BGMS device accuracy can lead to incorrect insulin dosing, which, when combined with other factors, can lead to increased episodes of hypoglycemia.”
      • “For hospitalized patients who may be seriously ill, any inaccuracies in the meters would further increase the risk to these patients.”2
September 2014: FDA clears the first BGMS (StatStrip) as accurate enough for use with critically ill patients. FDA issues press release stating that:
      • “Users of BGMS with manufacturer instructions that do not provide for use with critically ill hospital patients would be subject to the high complexity testing requirements under the Clinical Laboratory Improvement Amendments (CLIA) if such systems were to be used in the critically ill hospital population.”1

Stricter FDA Evaluation of Hospital BGMS

For critical care clearance, the FDA requires hospital BGMS to be designed for and tested with critically ill patients. Summary of studies performed to obtain the first FDA clearance for use in critical care Nova Biomedical spent nearly four years conducting formal studies of StatStrip in critical care hospital settings, including:
      • Data collected on critical care patients at 5 major university medical centers
      • 1,698 individual critical care patients encompassing 1,815 StatStrip sample analyses paired with an IDMS traceable laboratory glucose analyzer method
      • Data from multiple critical care settings representing 19 medical condition categories as designated by the World Health Organization and 257 subcategories of these conditions
      • Over 8,000 medications representing 33 parent drug classes as designated by the United States Pharmacopeia and 134 drug subclasses were studied for possible clinical interferences; no clinical interferences were observed
      • Testing was performed by healthcare professionals and POC waived operators
      • Hypoglycemia analysis of all patient glucose results <70 mg/dL to identify safety issues in the hypoglycemic range; no safety issues were found
      • Analysis of specimen collection site (central or peripheral) and specimen type (arterial or venous) to identify any issues with collection sites and specimen types; no issues were found
Each performance and statistical model showed that StatStrip demonstrates acceptable clinical performance in critical care settings when testing is performed by either healthcare professionals or POC waived operators. When used with patients who are receiving intensive medical intervention with complex medical conditions and drug regimens in critical care settings, StatStrip’s accuracy has been shown to have excellent correlation to central laboratory IDMS traceable reference methods. The most extensively studied and proven glucose test In addition to the FDA study, 138 other independent studies over the last eight years—including 53 critical care studies—have found no clinically significant interferences for StatStrip. This is a statement that no other BGMS manufacturer can make. StatStrip is the world’s most extensively studied and proven glucose test. It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care. Download a bibliography of publications here. StatStrip Xpress® is not currently FDA-cleared for use in intensive care settings.