K223085 is an FDA 510(k) clearance for the Miris Human Milk Analyzer (HMA). This device is classified as a Breast Milk Macronutrients Test System (Class II - Special Controls, product code QEI).
Submitted by Miris AB (Uppsala, SE). The FDA issued a Cleared decision on September 29, 2023, 364 days after receiving the submission on September 30, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1493. 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..
| 510(k) Number | K223085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2022 |
| Decision Date | September 29, 2023 |
| Days to Decision | 364 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QEI - Breast Milk Macronutrients Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1493 |
| 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. |