DeviceClearance

Product code QEI— Clinical Chemistry

Emily's Care Nourish Test System (Model 1)

Classification name
Breast Milk Macronutrients Test System
Device class
Class 2
Regulation
21 CFR 862.1493
Advisory panel
Clinical Chemistry
Total cleared
3
First cleared
Most recent

FDA classification definition

“A breast milk macronutrient test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of infants.”

— U.S. Food and Drug Administration, device classification record for product code QEI under 21 CFR 862.1493, via openFDA

Market context for product code QEI

FDA has cleared 3 devices under product code QEI between 2018 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QEI

Recent clearances under product code QEI

Data sourced from openFDA. This site is unofficial and independent of the FDA.