FDA Clears Nova’s Stat Profile Prime Plus Analyzer for Micro Capillary Sample Mode


Contact: Terry Austin
(781) 647-3700

Waltham, MA - Nova Biomedical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a micro capillary sample mode on the Stat Profile Prime Plus® Critical Care analyzer. Prime Plus now performs an 11-test panel including pH, PCO2, PO2, Na, K, iCa, iMg, Cl, glucose, lactate, and hematocrit with just 90 microliters of capillary blood, or a complete 22-test profile on just 135 microliters of blood. The micro capillary sampling mode adds to Prime Plus blood conservation capabilities for critical care diagnostic testing and is available as a standard feature on all Prime Plus analyzers.

Stat Profile Prime Plus provides the most modern and clinically effective critical care test menu including pH, PCO2, PO2, SO2%, Na, K, iCa, iMg, Cl, TCO2, glucose, lactate, creatinine, urea, hematocrit, hemoglobin, MCHC, estimated plasma volume, CO-Oximetry panel, and 34 calculated results in a simple, compact analyzer. Prime Plus combines maintenance-free, replaceable cartridge technology for sensors and reagents with patented, maintenance-free, whole blood CO-Oximetry technology.

Blood loss for laboratory testing of critically ill patients has been shown to be a major contributor to severe anemia and increased administration of blood products, which is furthermore associated with prolonged hospital stay and increased mortality rate.1 According to Terry Austin, Sales Product Line Manager for Prime Plus analyzer, “Prime Plus microsample volume and comprehensive test menu provide a major blood-saving benefit for diagnostic testing of critically ill patients. Prime Plus delivers gases, electrolytes, glucose, lactate, hematocrit, or any subset of these tests on just two drops (90 microliters) of blood. A basic metabolic panel of electrolytes, glucose, lactate, creatinine, urea, and hematocrit is available on 135 microliters, 1/50th the volume of blood needed for the same tests in the central laboratory.”

The use of small-volume microcapillary blood collection tubes with Prime Plus eliminates sample over-draws, dead volume, and sample waste of syringe or vacuum tube devices. Prime Plus comprehensive test menu enables scheduled bundling of tests to eliminate multiple sample draws, use of multiple sample containers, and amount of blood drawn for critical care testing.

About Nova Biomedical
Incorporated in 1976 and based in Waltham, MA, Nova Biomedical is a world leader in the development and manufacturing of whole blood, point-of-care and critical care analyzers, as well as instruments for cell culture monitoring in the biotechnology market. Nova uses biosensor technology in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for stat measurement of over 24 analytes. Nova’s BioProfile line has pioneered comprehensive cell culture testing, providing over 20 critical cell culture tests for a broad range of cell culture applications. Nova employs over 1,500 people worldwide and has wholly owned subsidiaries located in Australia, Benelux, Brazil, Canada France, Germany, Great Britain, Italy, Japan, Spain, and Switzerland. Certified by the International Organization for Standardization, Nova has manufacturing operations located in the U.S. and Taiwan.

  1. Helmer P et al. Avoidable Blood Loss in Critical Care and Patient Blood Management: Scoping Review of Diagnostic Blood Loss. Clinical Medicine 2022, 11, 320.