FDA Product Code QEI: Breast Milk Macronutrients Test System
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.
Leading manufacturers include Miris AB and Lactation Lab, Inc..
3
Total
2
Cleared
270d
Avg days
2018
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Breast Milk Macronutrients Test System Devices (Product Code QEI)
3 devices
Cleared
May 03, 2024
Emily's Care Nourish Test System (Model 1)
Lactation Lab, Inc.
Chemistry
133d
Cleared
Sep 29, 2023
Miris Human Milk Analyzer (HMA)
Miris AB
Chemistry
364d
Not Cleared
Dec 21, 2018
Miris Human Milk Analyzer
Miris AB
Chemistry
312d
About Product Code QEI - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QEI since 2018, with 2 receiving FDA clearance (average review time: 270 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.