The FDA has granted 510(k) clearance for the first finger-stick capillary testing meter for critically ill patients with and without diabetes, Nova Biomedical announced in a press release.
The StatStrip glucose hospital meter system (Nova Biomedical) is the only glucose meter to earn this clearance and can now be used with arterial, venous or capillary specimens from all patients, including those who are critically ill, according to the release. The use of any other meter with critically ill patients is considered off-label by the FDA and high-complexity testing by CMS under the Clinical Laboratory Improvement Amendments (CLIA). The new capillary clearance designation eliminates the need for hospitals using StatStrip to define “critically ill.”
The 510(k) clearance follows extensive prospective and retrospective studies performed at Mayo Clinic in Rochester, Minnesota, and Johns Hopkins Bayview Medical Center. The submission included data from 16,778 patients aged 1 month to 106 years, all receiving intensive medical intervention or therapy in critical and intensive care settings, including burn, cardiac, medical, orthopedic, neurological and surgical.
StatStrip’s capillary results were equivalent to the arterial and venous plasma results measured on a central laboratory isotope dilution mass spectrometry (IDMS) traceable reference method, according to the company. The FDA clearance indicates that StatStrip is safe, effective and reliable for use by CLIA-waived operators with critically ill patients. StatStrip is the only glucose technology for point-of-care testing that measures and corrects for abnormal hematocrit and has no clinically significant interferences, which can lead to the mismanagement of critically ill patients, the release stated.
In 2014, the FDA extended the indication of the StatStrip glucose hospital meter system to critically ill patients within hospitals, making it the first device cleared for this indication. As Endocrine Today previously reported, the StatStrip glucose hospital meter system was originally cleared in 2006 for hospital use to monitor control of diabetes, but not for patients with critical illnesses. For the 2014 approval, the FDA considered data from a study of more than 1,650 patients whose medical situations varied by condition, medication and hospital department.
“Results showed agreement in blood glucose results compared to a comparator laboratory glucose analyzer in all patient types tested,” according to a release from the FDA at the time of the approval. – by Regina Schaffer