FDA 510K for Breast Milk Macronutrients Test System
The Breast Milk Macronutrients Test System is a diagnostic tool designed to measure the macronutrient profile of human breast milk, including fat, protein, and carbohydrate levels. By providing accurate insights into the milk’s nutritional content, this system enables healthcare providers to ensure that breast milk meets the specific nutritional needs of infants, particularly in clinical environments and milk banks.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Breast Milk Macronutrients Test System
FDA 510K for Breast Milk Macronutrients Test System Device Code and Regulation Number
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.
| S.
No. |
Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | QEI | Breast Milk Macronutrients Test System | Breast Milk Macronutrients Test System | 21 CFR 862.1493 | 2 |
Breast Milk Macronutrients Test System
Intended Use
It is a device that measures the concentration of fat, protein, and carbohydrate in human milk. It also calculates total solids and energy values. These measurements assist in the nutritional management of newborns, including preterm infants. The device is intended for use by trained healthcare personnel in clinical laboratories.
Device Description
A Breast Milk Macronutrient Test System is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measures, in conjunction with other clinical assessments, may be used to aid in the nutritional management of infants.
The device is an in vitro diagnostic tool that utilizes quantitative mid-infrared spectroscopy as its technical method. It is designed to analyze human breast milk, providing precise measurements and insights into its composition.
Performance Testing (Analytical) for Breast Milk Macronutrients Test System
- Precision (Reproducibility and Repeatability)
- Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ)
- Interference study
- Linearity
- Sensitivity
- Accuracy
- Trueness, Method Comparison Testing
- Stability study
Clinical Testing
No Guidance available for 510k submission