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U.S. Department of Health and Human Services

Product Classification

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Device breast milk macronutrients test system
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.
Physical State In vitro diagnostic device
Technical Method Quantitative, mid-infrared spectroscopy
Target Area Human breast milk
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQEI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1493
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible