# K234088: Emily's Care Nourish Test System (Model 1)

- Pathway: 510(k) (Traditional)
- Applicant: Lactation Lab, Inc.
- Decided: May 3, 2024 after 133 days
- Product code: QEI (Breast Milk Macronutrients Test System)
- Device class: 2
- Regulation: 21 CFR 862.1493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180007 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180007: Miris Human Milk Analyzer, Miris AB (2018) Summary page 4.

## Indications for use
Emily’s Care Nourish Test System (Model 1) quantitatively measures the concentration of protein, fat (triglycerides), and carbohydrates (lactose) in human milk. It also provides calculated values for calories (energy). These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at point of care or clinical laboratory settings.

Source page: https://510kreport.com/device/K234088
Methodology: https://510kreport.com/methodology