NEW YORK (360Dx) — The US Food and Drug Administration said last week that it has granted marketing authorization to the Miris human milk analyzer for the measurement of nutrients in breast milk following a de novo premarket review of the system.
The infrared spectroscopy-based analyzer quantitatively measures the concentration of fat, carbohydrate, and protein in human milk, and provides calculated values for total solids and energy. These measurements can be used by healthcare providers in the nutritional management of newborns, including preterm, and infants, the FDA said.
"For the first time, doctors have access to a test to help analyze the nutrients in breast milk," Courtney Lias, director of the division of chemistry and toxicology devices in the FDA's Center for Devices and Radiological Health, said in a statement. "While this test is not for everyone, it has the potential to aid parents and healthcare providers, mainly in a hospital setting, in better assessing the nutrient needs of certain babies who are not growing as expected."
The FDA said it reviewed data from Uppsala, Sweden-based Miris on 112 samples of human milk and found the analyzer performed comparably to independent methods, although it noted that certain conditions — such as  taking prescription medicine — may interfere with its accuracy.
"Health care professionals should carefully evaluate the Miris Human Milk Analyzer test results in conjunction with clinical assessments — such as weight and growth —  to inform their discussions with parents in creating a nutritional management plan for an infant or newborn," the agency said.
It added that the de novo authorization creates a new regulatory classification, "which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device."