FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk

FDA News Release

• For Immediate Release: December 21, 2018

Today, the U.S. Food and Drug Administration permitted marketing of the Miris Human Milk Analyzer, a new diagnostic test to aid healthcare professionals in measuring nutrients in breast milk, including the concentration of fat, carbohydrate, protein, total solids and energy. The test provides healthcare professionals with a new tool to aid in the nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions.

“Breast milk provides many health benefits to infants, and for many babies it can meet their early nutritional needs. But some infants — including those who may be born preterm or have certain health conditions — may need additional nutrients in order to support their optimal growth,” said Courtney Lias, Ph.D. director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health. “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.”

Some infants who are born prematurely or with health conditions may have special nutritional needs. Breast milk composition can vary in individuals, and, in certain cases, breast milk may not contain sufficient protein and energy levels for these infants with increased nutrient needs. In those instances, healthcare professionals may want to test the nutrient content of the milk to help guide nutritional care. Knowing the macronutrient content of the breast milk may help the health care team and parents make informed decisions on how to fortify the breast milk based on the individual needs of the infant.

The Miris Human Milk Analyzer uses an infrared spectroscopy system to analyze samples of human milk and provide a quantitative measurement of fat, protein and total carbohydrate content as well as calculations of the total solids and energy content contained in the milk. This is a prescription device intended for use by trained health care personnel at clinical laboratories.

The FDA reviewed data submitted by the sponsor of 112 samples of human milk to analyze the performance of the device. For the study, the sponsor tested the same 112 samples in the machine and compared them to the expected true values obtained by independent methods; both systems provided similar results for each test. The data showed that the Miris Human Milk Analyzer test was effective at determining levels of protein, fat and carbohydrate in the milk. There may be conditions that limit the information available from the Miris Human Milk Analyzer. For example, certain medications that a nursing mother may be taking could interfere with the test’s ability to accurately measure nutrient levels in breast milk.

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 FDA reviewed the Miris Human Milk Analyzer test through the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, to provide for the accuracy and reliability 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. This action also creates a new regulatory classification, which means that subsequent devices of the same type, including 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.

The FDA granted marketing authorization of the Miris Human Milk Analyzer test to Miris AB.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.