FDA product code QEI: Breast Milk Macronutrients Test System
QEI is the FDA product code for breast milk macronutrients test system. It is a Class II device, regulated under 21 CFR 862.1493 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under QEI, 2 in the last five years, from 2 different applicants. The average 510(k) review took 248 days (median 248); 133 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for QEI devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Breast Milk Macronutrients Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.1493 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for QEI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 364 |
| 2024 | 1 | 133 |
Compare with all 510(k) review times · Search every QEI clearance
Top QEI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lactation Lab, Inc. | 1 | 2024-05-03 |
| Miris AB | 1 | 2023-09-29 |
Most recent QEI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234088 | Lactation Lab, Inc. | Emily's Care Nourish Test System (Model 1) | 2024-05-03 | 133 |
| K223085 | Miris AB | Miris Human Milk Analyzer (HMA) | 2023-09-29 | 364 |
Recalls for QEI devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-03-16.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code QEI?
QEI is the FDA product code for breast milk macronutrients test system. It is a Class II device, regulated under 21 CFR 862.1493 and reviewed by the Clinical Chemistry panel.
What device class is QEI?
Class II, regulation 21 CFR 862.1493. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEI?
Across 2 cleared submissions the average was 248 days from receipt to decision (median 248).
Which companies have the most QEI clearances?
Lactation Lab, Inc. (1); Miris AB (1).
Have QEI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-03-16.
Next steps
- Run an FDA pathway report with predicate devices for product code QEI
- Run a recall and safety report across every QEI manufacturer
- Watch product code QEI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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