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Home»News»FDA clears Nova’s Stat Profile Prime Plus analyzer for microcapillary sample operation
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FDA clears Nova’s Stat Profile Prime Plus analyzer for microcapillary sample operation

healthtostBy healthtostMay 17, 2024No Comments2 Mins Read
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Fda Clears Nova's Stat Profile Prime Plus Analyzer For Microcapillary
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Nova Biomedical is pleased to announce that the US Food and Drug Administration (FDA) has granted 510(k) clearance for a microcapillary sampler to Stat Profile Prime Plus® Critical Care Analyst. Prime Plus now runs a panel of 11 tests including pH, PCO2P.O2, Na, K, iCa, iMg, Cl, glucose, lactate and hematocrit with just 90 microliters of capillary blood or a complete 22-test profile in just 135 microliters of blood. The microcapillary sampling function adds to the Prime Plus blood storage capabilities for critical care diagnostic testing and is available as a standard function on all Prime Plus analyzers.

Image credit: Nova Biomedical

Stat Profile Prime Plus provides the most modern and clinically effective critical care test menu including pH, PCO2P.O2SO2%, Na, K, iCa, iMg, Cl, TCO2, glucose, lactate, creatinine, urea, hematocrit, hemoglobin, MCHC, estimated plasma volume, CO-Oximetry table and 34 calculated results in one simple, compact analyzer. Prime Plus combines maintenance-free sensor and reagent cartridge replacement technology with patented, maintenance-free whole blood CO-Oximetry technology.

Blood loss for laboratory tests in critically ill patients has been shown to be a major contributor to severe anemia and increased transfusion of blood products, which is also associated with prolonged hospital stay and increased mortality.1

The Prime Plus microspecimen volume and complete test menu provide a significant blood-saving advantage for the diagnostic testing of critically ill patients. Prime Plus provides gases, electrolytes, glucose, lactate, hematocrit or any subset of these tests in just two drops (90 microliters) of blood. A basic metabolic panel of electrolytes, glucose, lactate, creatinine, urea, and hematocrit is available in 135 microliters, 1/50 the volume of blood required for the same tests in the central laboratory.

Terry Austin, Sales Product Line Manager for Prime Plus Analyst

Using low-volume microcapillary blood collection tubes with Prime Plus eliminates oversampling, dead volume, and sample waste from syringe or vacuum tube devices. The complete Prime Plus test menu allows scheduled test bundles to eliminate multiple samples, use multiple sample containers, and blood volume drawn for critical care testing

analyzer clears FDA microcapillary Novas operation prime Profile sample Stat
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February 26, 2026

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