December 26, 2018
The US Food and Drug Administration (FDA) has cleared for marketing a diagnostic test to measure nutrients in breast milk, including the concentration of fat, carbohydrates, protein, total solids, and energy.
The Miris Human Milk Analyzer (Miris AB) can help with nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions. Knowing the macronutrient content of the breast milk may help clinicians make informed decisions on how to fortify the breast milk based on the individual needs of the infant, the FDA explained in a news release.
"For the first time, doctors have access to a test to help analyze the nutrients in breast milk. 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," Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices in the FDA's Center for Devices and Radiological Health, said in the release.
The Miris Human Milk Analyzer uses an infrared spectroscopy system to analyze human milk and provide a quantitative measurement of fat, protein, and total carbohydrate content. It can also calculate the total solids and energy content of the milk. It is intended for use by trained personnel in clinical laboratories.
The accuracy of the Miris analyzer was demonstrated in an FDA analysis of 112 samples of human milk tested by the Miris analyzer and by independent methods. Both methods were similarly effective at determining levels of protein, fat, and carbohydrates in the milk.
However, the FDA said certain medications that a nursing mother may be taking could interfere with the test's ability to accurately measure nutrient levels in breast milk.
The agency advises healthcare providers to carefully evaluate the Miris Human Milk Analyzer test results in conjunction with clinical assessments (such as weight and growth) when creating a nutritional management plan for an infant.
The FDA reviewed the Miris Human Milk Analyzer test through the de novo premarket review pathway, a regulatory pathway for some new types of low- to moderate-risk devices.
Along with this marketing authorization, the FDA is establishing "special controls" that set forth the agency's expectations in ensuring the accuracy, reliability, and effectiveness of tests intended to measure the nutritional content of human milk to aid in the nutritional management of certain infants.
"These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type," the agency said.
More information on this announcement is available on the FDA website.