Emily's Care Nourish Test System (Model 1)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT ## I Background Information: A 510(k) Number K234088 B Applicant Lactation Lab Inc. C Proprietary and Established Names Emily's Care Nourish Test System (Model 1) D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | QEI | Class II | 21 CFR 862.1493 - Breast Milk Macronutrients Test System | CH - Clinical Chemistry | ## II Submission/Device Overview: A Purpose for Submission: New device B Measurand: Fat, lactose, and protein in breast milk C Type of Test: Quantitative, Colorimetric Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) 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. The device is for prescription use only. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only The Emily's Care Nourish Test System (Model 1) is not the sole basis for nutritional management of the newborn. Use of the Emily's Care Nourish Test System (Model 1) device is intended as part of an overall treatment plan and nutritional measures for newborns. The Emily's Care Nourish Test System (Model 1) is an aid to the healthcare providers’ standard of care assessment of nutritional management of newborns through monitoring of weight gain and growth. Do not use the Emily's Care Nourish Test System (Model 1) with fortified human milk or infant formula. Clinicians should follow clinical practice guidelines and standard of care when supplementing or fortifying human breast milk. D Special Instrument Requirements: 1. iPhone Models 12 mini, 12 Pro, and 12 Pro Max, 13, 13 Pro, 13 Pro Max, 14, and 14 ProMax that run iOS 16 or 17 operating systems. Phones and iOS versions that are not validated for use with the candidate device will be prevented from opening the Emily’s Care App. The sponsor has added a statement to their labeling that the iPhones should be dedicated for use with the app. 2. Emily’s Care mobile iOS application provides guided instructions to use and scan the test strip, interpret the spectrometer readings into concentrations, and displays the final results. K234088 - Page 2 of 16 {2} K234088 - Page 3 of 16 ## IV Device/System Characteristics: ### A Device Description: The Emily's Care Nourish Test System (Model 1) is an analytical system designed to measure the concentration of fat, carbohydrates (lactose), and protein in human milk at point of care using an enzyme-based test strip (Macronutrient Breast Milk Test Strip) with three different reagent pads and a smartphone camera with an associated application as a spectrometer. The system is comprised of a dedicated iPhone validated for use with the device (not provided), the Emily’s Care app, test strips, a single use reference card, pipettes and tubes to collect the milk, and a lightbox. ### B Principle of Operation: The Macronutrient Breast Milk Test Strip is an enzyme-based test strip that contains three separate reagent pads to measure the concentration of fat (triglycerides), carbohydrates (lactose), and total protein in human breast milk. The individual chemical coatings of each reagent pad produce specific enzymatic reactions coupled with a colorimetric dye, resulting in a color change on the test strip paper depending on the concentration of protein, fat (triglycerides) and carbohydrates (lactose) present in the breast milk sample. Calories (kcal/dl) are calculated based on these values. The test strip is placed on a reference card inside a lightbox and is scanned using the built-in functionality of the Emily’s Care mobile application and the phone’s camera. The mobile application guides the user through the measurement steps and displays the final results. ### C Instrument Description Information: 1. Instrument Name: Emily's Care Nourish Test System (Model 1) 2. Specimen Identification: Specimens are identified and entered manually at the time of analysis. 3. Specimen Sampling and Handling: Fresh specimens can be analyzed with no pretreatment. Samples that were stored refrigerated or frozen must be brought to 68-104°F prior to analysis. Complete instructions on sample handling are provided in the labeling. 4. Calibration: There is no separate calibration step performed by the user. {3} K234088 - Page 4 of 16 5. Quality Control: Recommendations for the quality control are provided in the labeling. V Substantial Equivalence Information: A Predicate Device Name(s): Miris Human Milk Analyzer B Predicate 510(k) Number(s): DEN180007 C Comparison with Predicate(s): | Device & Predicate Device(s): | K234088 | DEN180007 | | --- | --- | --- | | Device Trade Name | Emily’s Care Nourish Test System (Model 1) | Miris Human Milk Analyzer | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | Quantitatively measures the concentration of fat, carbohydrates, and protein in human milk and provides calculated values for calories (energy). These measurements are used in conjunction with other clinical assessments, to aid in the nutritional management of newborns, including preterm, and infants. | Same | | Sample type | Human Breast Milk | Same | | General Device Characteristic Differences | | | | Test System | Emily Care’s app run on an iPhone with a Lightbox | Miris Human Milk Analyzer | | Measuring Range | Fat: 0.6 – 6.0 g/dL | Fat: 0.6 - 6.0 g/dL | | | | Crude Protein: 0.8 – 3.0 g/dL | | | Protein: 0.6 – 2.4 g/dL | True Protein: 0.6 – 2.4 g/dL | | | Lactate: 4.5 – 9.5 g/dL | Carbohydrates: 6.6 – 8.7 g/dL | | Testing Environment | Point-of-Care settings by trained professionals. | Clinical laboratory settings by trained professionals. | | Sampling Method | Test strip dipped in breastmilk sample | Breastmilk samples are injected into the measuring | {4} K234088 - Page 5 of 16 | Device & Predicate Device(s): | K234088 | DEN180007 | | --- | --- | --- | | | | unit via the instrument inlet using a syringe | | Principle of Operation | Spectrophotometry | Mid-infrared (mid-IR) transmission spectroscopy | ## VI Standards/Guidance Documents Referenced: Clinical & Laboratory Standards Institute (CLSI) EP05-A3: Evaluation of Precision of Qualitative Measurement Methods Procedures; Approved Guideline – Third Edition CLSI EP07 3rd Edition: Interference Testing in Clinical Chemistry CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures Special Controls: 21 CFR 862.1493 Breast milk macronutrients test system special controls ## VII Performance Characteristics (if/when applicable): ### A Analytical Performance: #### 1. Precision/Reproducibility: The precision of the Emily’s Care Nourish Test System (Model 1) for measuring fat, protein, and lactose was evaluated following the CLSI EP05-A3 guideline. A precision study was conducted at site A by testing five milk samples on two devices by two operators over 21 different days, with duplicate measurements per run and two runs per day for a total of 84 measurements per sample. Additional precision studies were conducted at sites B, C, D, E, and F (point-of-care sites and operators), where milk samples were analyzed using two devices by two operators over five days with duplicate measurements per run and two runs per day for a total of 20 measurements per sample. | Protein | | | | Repeatability (within-run variation | | Intermediate Precision (within-lab variation) | | | --- | --- | --- | --- | --- | --- | --- | --- | | Site | Sample | N | Mean (g/dL) | SD | CV% | SD | CV% | | | | | | (g/dL) | | (g/dL) | | | Site A | 1 | 84 | 0.9 | 0.05 | 5.6 | 0.05 | 5.6 | | | 2 | 84 | 1.2 | 0.05 | 4.1 | 0.06 | 5.0 | | | 3 | 84 | 0.6 | 0.03 | 4.9 | 0.03 | 4.9 | {5} | Protein | | | | Repeatability (within-run variation | | Intermediate Precision (within-lab variation) | | | --- | --- | --- | --- | --- | --- | --- | --- | | Site B | 4 | 20 | 0.8 | 0.05 | 6.3 | 0.06 | 7.5 | | | 5 | 20 | 0.9 | 0.06 | 6.7 | 0.06 | 6.7 | | | 6 | 20 | 1.7 | 0.06 | 3.5 | 0.09 | 5.0 | | | 7 | 20 | 1.1 | 0.07 | 6.4 | 0.08 | 7.3 | | | 8 | 20 | 1.2 | 0.04 | 3.3 | 0.04 | 3.3 | | Site C | 4 | 20 | 0.8 | 0.06 | 7.5 | 0.08 | 10.0 | | | 5 | 20 | 0.9 | 0.05 | 5.6 | 0.06 | 6.7 | | | 6 | 20 | 1.7 | 0.06 | 3.5 | 0.06 | 3.5 | | | 7 | 20 | 1.1 | 0.05 | 4.5 | 0.06 | 5.5 | | | 8 | 20 | 1.2 | 0.05 | 4.2 | 0.06 | 5.0 | | Protein | | | | Repeatability (within-run variation | | Intermediate Precision (within-lab variation) | | | --- | --- | --- | --- | --- | --- | --- | --- | | Site D | 4 | 20 | 0.8 | 0.04 | 5.0 | 0.04 | 5.0 | | | 5 | 20 | 0.9 | 0.05 | 5.6 | 0.06 | 6.7 | | | 6 | 20 | 1.7 | 0.07 | 4.1 | 0.07 | 4.1 | | | 7 | 20 | 1.1 | 0.05 | 4.5 | 0.06 | 5.5 | | | 8 | 20 | 1.2 | 0.05 | 4.2 | 0.06 | 5.0 | | Site E | 9 | 20 | 0.6 | 0.04 | 7.2 | 0.05 | 7.5 | | | 10 | 20 | 0.9 | 0.03 | 3.8 | 0.05 | 6.5 | | | 11 | 20 | 1.2 | 0.04 | 3.7 | 0.07 | 5.6 | | Site F | 9 | 20 | 0.6 | 0.03 | 5.1 | 0.04 | 7.2 | | | 10 | 20 | 0.9 | 0.05 | 5.8 | 0.05 | 6.4 | | | 11 | 20 | 1.2 | 0.04 | 3.8 | 0.07 | 5.4 | | Fat | | | | Repeatability (within-run variation | | Intermediate Precision (within-lab variation) | | | --- | --- | --- | --- | --- | --- | --- | --- | | Site | Sample | N | Mean (g/dL) | SD | CV% | SD | CV% | | | | | | (g/dL) | | (g/dL) | | | Site A | 1 | 84 | 2.3 | 0.08 | 3.5 | 0.09 | 4.0 | | | 2 | 84 | 3.1 | 0.15 | 4.9 | 0.16 | 5.2 | | | 3 | 84 | 5.7 | 0.14 | 2.5 | 0.15 | 2.6 | | Site B | 4 | 20 | 1.0 | 0.08 | 8.0 | 0.11 | 11.0 | | | 5 | 20 | 1.2 | 0.08 | 6.7 | 0.11 | 9.2 | K234088 - Page 6 of 16 {6} | Fat | | | | Repeatability (within-run variation | | Intermediate Precision (within-lab variation) | | | --- | --- | --- | --- | --- | --- | --- | --- | | | 6 | 20 | 3.1 | 0.10 | 3.2 | 0.12 | 3.9 | | | 7 | 20 | 4.0 | 0.14 | 3.5 | 0.18 | 4.5 | | | 8 | 20 | 4.5 | 0.20 | 4.4 | 0.22 | 4.9 | | Site C | 4 | 20 | 1.0 | 0.05 | 5.0 | 0.08 | 8.0 | | | 5 | 20 | 1.2 | 0.07 | 5.8 | 0.09 | 7.5 | | | 6 | 20 | 3.1 | 0.09 | 2.9 | 0.09 | 2.9 | | | 7 | 20 | 4.0 | 0.19 | 4.8 | 0.20 | 5.0 | | | 8 | 20 | 4.6 | 0.25 | 5.4 | 0.27 | 5.9 | | Site D | 4 | 20 | 1.0 | 0.06 | 6.0 | 0.07 | 7.0 | | | 5 | 20 | 1.2 | 0.11 | 9.2 | 0.11 | 9.2 | | | 6 | 20 | 3.1 | 0.16 | 5.2 | 0.17 | 5.6 | | | 7 | 20 | 3.9 | 0.12 | 3.1 | 0.12 | 3.1 | | | 8 | 20 | 4.5 | 0.18 | 4.0 | 0.19 | 4.2 | | Fat | | | | Repeatability (within-run variation | | Intermediate Precision (within-lab variation) | | | --- | --- | --- | --- | --- | --- | --- | --- | | Site E | 9 | 20 | 2.2 | 0.10 | 4.6 | 0.15 | 6.8 | | | 10 | 20 | 3.1 | 0.05 | 1.7 | 0.13 | 4.2 | | | 11 | 20 | 5.8 | 0.20 | 3.5 | 0.21 | 3.6 | | Site F | 9 | 20 | 2.3 | 0.10 | 4.3 | 0.18 | 8.1 | | | 10 | 20 | 3.1 | 0.08 | 2.6 | 0.16 | 5.1 | | | 11 | 20 | 5.8 | 0.13 | 2.2 | 0.13 | 2.2 | | Lactose | | | | Repeatability (within-run variation | | Intermediate Precision (within-lab variation) | | | --- | --- | --- | --- | --- | --- | --- | --- | | Site | Sample | N | Mean (g/dL) | SD | CV% | SD | CV% | | | | | | (g/dL) | | (g/dL) | | | Site A | 1 | 84 | 5.8 | 0.20 | 3.5 | 0.21 | 3.6 | | | 2 | 84 | 7.4 | 0.25 | 3.4 | 0.26 | 3.5 | | | 3 | 84 | 8.6 | 0.32 | 3.7 | 0.32 | 3.7 | | Site B | 4 | 20 | 7.5 | 0.12 | 1.6 | 0.15 | 2.0 | | | 5 | 20 | 8.0 | 0.12 | 1.5 | 0.12 | 1.5 | | | 6 | 20 | 8.1 | 0.16 | 2.0 | 0.20 | 2.5 | | | 7 | 20 | 8.5 | 0.17 | 2.0 | 0.21 | 2.5 | | | 8 | 20 | 9.0 | 0.11 | 1.2 | 0.12 | 1.3 | K234088 - Page 7 of 16 {7} | Lactose | | | | Repeatability (within-run variation | | Intermediate Precision (within-lab variation) | | | --- | --- | --- | --- | --- | --- | --- | --- | | Site C | 4 | 20 | 7.5 | 0.16 | 2.1 | 0.16 | 2.1 | | | 5 | 20 | 8.0 | 0.12 | 1.5 | 0.13 | 1.6 | | | 6 | 20 | 8.2 | 0.18 | 2.2 | 0.18 | 2.2 | | | 7 | 20 | 8.6 | 0.13 | 1.5 | 0.17 | 2.0 | | | 8 | 20 | 9.0 | 0.12 | 1.3 | 0.17 | 1.9 | | Site D | 4 | 20 | 7.5 | 0.12 | 1.6 | 0.13 | 1.7 | | | 5 | 20 | 8.0 | 0.13 | 1.6 | 0.13 | 1.6 | | | 6 | 20 | 8.2 | 0.09 | 1.1 | 0.17 | 2.1 | | | 7 | 20 | 8.5 | 0.16 | 1.9 | 0.23 | 2.7 | | | 8 | 20 | 9.0 | 0.13 | 1.4 | 0.16 | 1.8 | | Site E | 9 | 20 | 5.7 | 0.09 | 1.5 | 0.16 | 2.9 | | | 10 | 20 | 7.5 | 0.21 | 2.8 | 0.22 | 2.9 | | | 11 | 20 | 8.8 | 0.17 | 1.9 | 0.20 | 2.3 | | Site F | 9 | 20 | 5.7 | 0.21 | 3.7 | 0.23 | 4.0 | | | 10 | 20 | 7.6 | 0.17 | 2.3 | 0.22 | 2.9 | | | 11 | 20 | 8.8 | 0.09 | 1.0 | 0.20 | 2.3 | # 2. Linearity: The linearity of the candidate device for the parameters of protein, fat, and lactose was evaluated. Nine levels with fat concentrations spanning the reportable range were analyzed on one device over one day, and each linearity sample was analyzed in duplicate. The observed values were plotted against the expected values and linear regression analysis was performed. The results are provided in the table below. | Analyte | Concentration Range Tested (g/dL) | R2 | Slope | Intercept | | --- | --- | --- | --- | --- | | Protein | 0.2 – 3.2 | 0.998 | 0.996 | 0.0404 | | Fat | 0.5 – 9.0 | 0.998 | 1.03 | -0.00167 | | Lactose | 3.5 – 11.1 | 0.997 | 1.03 | -0.0556 | These results support the claimed measuring range of $0.6 - 2.4\mathrm{g / dL}$ for protein, $0.6 - 6.0\mathrm{g / dL}$ for fat, and $4.5 - 9.5\mathrm{g / dL}$ for lactose. K234088 - Page 8 of 16 {8} K234088 - Page 9 of 16 # 3. Analytical Specificity/Interference: The sponsor performed a study following CLSI EP07 3rd Edition to evaluate whether endogenous or exogenous substances that could be present in breast milk could cause interference with the protein, fat, or lactose measurements of the candidate device. The study was conducted by spiking six samples of milk with concentrations of fat, protein, or lactate that ranged from high to low for each macronutrient with known concentrations of potentially interfering substances. Each sample was analyzed in duplicate using 3 different test strips. The difference between the test samples and control samples were calculated. Significant interference was defined as a difference >0.1 g/dL for protein, a difference >0.1 g/dL for fat and >0.15 g/dL for carbohydrates (lactose) relative to the reference sample without interferent. The following substances were found to interfere and the sponsor states in the labeling that milk that may contain any of the substances listed below should not be analyzed with the Emily's Care Nourish Test System (Model 1). | Interferent Name | Conc at which interference was first observed (mg/L) | Macronutrient(s) Affected | | --- | --- | --- | | Hydrocodone | 0.1 | Protein: Positive Bias | | Folic Acid* | 0.05 | Protein: Positive Bias | | Gentamicin | 0.15 | Protein: Positive Bias | | Clindamycin | 0.5 | Protein: Positive Bias | | Morphine | 0.05 | Protein: Positive Bias | | Oxycodone | 0.05 | Protein: Positive Bias | | Hemoglobin | 0.01 | Protein: Positive Bias Fat: Positive Bias Lactose: Positive Bias | | Phenytoin | 0.10 | Protein: Positive Bias | | Bronopol | 0.01 | Protein: Positive Bias Fat: Negative Bias | The compounds and the highest concentration that do not interfere are listed in the table below: {9} K234088 - Page 10 of 16 | Drug/Substance Tested | Highest conc tested at which no interference was observed (mg/L) | | --- | --- | | Loratadine | 25.0 | | Diphenhydramine (Tablet) | 125.0 | | Diphenhydramine (Liquid) | 62.5 | | Acetaminophen | 81.3 | | Ibuprofen | 50.0 | | Naprosyn | 12.5 | | Diclofenac | 12.5 | | Spironolactone | 12.5 | | Zolpidem | 2.5 | | Citalopram | 2.5 | | Escitalopram | 1.5 | | Amoxicillin | 23.0 | | Ceftriaxone | 20.0 | | Ciprofloxacin | 100.0 | | Doxycycline | 100.0 | | Cefazolin | 25.0 | | Vancomycin | 120.0 | | Metronidazole | 125.0 | | Ampicillin | 50.0 | | Cephalexin | 50.0 | | Pseudoephedrine | 20.0 | | Prednisolone | 20.0 | | Aspirin | 81.0 | | Caffeine | 75.0 | | Progesterone (pill) | 25.0 | | Methyldopa | 25.0 | | Sertraline | 25.0 | | Paroxetine | 25.0 | | Carbamazepine | 25.0 | | Metoprolol | 25.0 | | Propranolol | 25.0 | | Hydrochlorothiazide | 25.0 | {10} *The sponsor added the following limitations to their labeling: Folic acid interferes with this test by causing falsely high protein values. Folic acid is the synthetic (that is, not generally occurring naturally) form of folate that can be used in supplements and in fortified foods and may be used in some infant formulas and fortified milks. Infant formulas and fortified milks should not be used with the Emily Care's Nourish Test System (Model 1). Only human breast milk should be used with this test. The CDC recommends pregnant and lactating mothers take 600 µg of folic acid per day. Breast milk obtained from lactating mothers taking folic acid at 600 µg per day are not likely to have folic acid concentrations in breast milk that will cause interference in this assay. [1] Cochrane, K.M., Elango, R., Devlin, A.M. et al. Human milk unmetabolized folic acid is increased following supplementation with synthetic folic acid as compared to (6S)-5-methyltetrahydrofolic acid. Sci Rep 13, 11298 (2023). 4. Assay Reportable Range: Protein: 0.6 – 2.4 g/dL Fat: 0.6 – 6.0 g/dL Lactose: 4.5 – 9.5 g/dL 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): The Emily's Care Nourish Test System (Model 1) is traceable to certified reference materials and validated chemical methods. The validation of these chemical methods was reviewed and found to be acceptable. The applicant submitted a detailed traceability assurance plan which was reviewed and found to be acceptable. 6. Detection Limit: The Limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) of protein, fat, and lactose on the candidate device was established using a 5-day study protocol per CLSI EP17-A2 guideline. To evaluate the LoB, triplicate measurements were made on four blank samples over five days for a total of 60 measurements per analyte. The LoB was calculated as the mean of the blank results + 1.64*Standard Deviation (SD). For the LoD determination, 7 milk samples with low levels of protein, fat and lactose were tested in triplicate over 5 days for a total of 15 measurements per sample. LoD was calculated as LoB + 1.64 *SD pooled. For the LoQ determination, seven low-concentration samples were tested in triplicate across five days. To determine the LoQ the sponsor plotted a regression line of analyte concentration vs. the expected total error. The concentration at which the total error was 20% for that analyte was chosen as the LoQ. The LoQ for each of the three analytes is listed in the table below: K234088 - Page 11 of 16 {11} | Analyte | Protein g/dL | Fat g/dL | Lactose g/dL | | --- | --- | --- | --- | | LoB | 0.10 | 0.07 | 1.02 | | LoD | 0.23 | 0.21 | 1.19 | | LoQ | 0.32 | 0.33 | 4.06 | The sponsor’s labeling specifies that the lowest values that will be reported are 0.6 g/dL for protein and fat, and 4.5 g/dL for lactose. Please see the Assay Reportable Range section above. 7. **Assay Cut-Off:** Not applicable. 8. **Accuracy (Instrument):** Not applicable. 9. **Carry-Over and other flex studies:** The sponsor performed the following flex studies to evaluate the effect of environmental conditions and suboptimal handling of the samples or strips. - Carry-Over/Bleeding study to evaluate the impact of a color bleeding over onto the adjacent pad of the test strips. - Dip time study to evaluate whether accurate results could be produced if the user deviated from the recommended dipping time of 2 – 3 seconds. - Strip Misalignment/Strip Boundary studies to evaluate whether the App can determine when the test strip is misaligned. - Temperature and humidity study to evaluate the impact of various temperature and humidity scenarios. - Assay time study (incremental testing time study) to determine the effects of the test strip not being analyzed by the test system within the recommended time window. The sponsor provided sufficient information to support that the device is adequately robust to conditions that may reasonably be expected in the intended use environment and supports the labeled claims. B **Comparison Studies:** 1. **Method Comparison with Predicate Device:** The sponsor performed method comparison studies to determine the bias of the Emily’s Care Nourish Test System (Model 1). The comparator method for fat and protein was the predicate Miris Human Milk Analyzer™. The comparator method for lactose was a validated comparative chemical method. Regression analysis and bias estimations were based on first replicate results for the candidate device. The comparative method included the same K234088 - Page 12 of 16 {12} samples analyzed in triplicate. The mean of the triplicates results was used as the comparative values. Passing-Bablok regression of the data produced the following: | Analyte | N | Concentration tested | R2 | Slope (95% CI) | Intercept (95% CI) | | --- | --- | --- | --- | --- | --- | | Protein | 115 | 0.6 – 2.2 g/dL | 0.953 | 1.000 (1.000,1.000) | 0 (-3.997E-16, 0) | | Fat | 113* | 0.8 – 6.0 g/dL | 0.970 | 0.9926 (0.9470, 1.000) | 0.02602 (-0.04615, 0.1788) | | Lactose | 115 | 4.8 – 8.6 g/dL | 0.965 | 1.000 (1.0000, 1.058) | 0.03891 (-0.3447, 0.10000) | | Calories | 113* | 30 – 90 kcal/dL | 0.978 | 0.9828 0.9565, 1.011 | 1.286 (-0.5307, 2.884) | *Two samples were excluded as their fat concentrations were outside the claimed measuring range. The bias at low, medium, and high levels of each analyte was calculated. The results are presented in the table below. | Analyte | Concentration (g/dL) | Bias (g/dL) | 95% CI | | --- | --- | --- | --- | | Fat | 1.0 | 0.0186 | -0.04262, 0.1191 | | | 2.5 | 0.0074 | -0.04615, 0.10000 | | | 4.0 | -0.0037 | -0.07101, 0.09047 | | Protein | 0.8 | 0 | 0.0000, 0.0000 | | | 1.1 | 0 | 0.0000, 2.2204E-16 | | | 2.0 | 0 | 0.0000, 8.8818E-16 | | Lactose | 6.6 | 0.0389 | 0.0000, 0.10000 | | | 7.5 | 0.0389 | 0.0000, 0.10000 | | | 8.5 | 0.0389 | 0.0000, 0.1476 | | Calories | 45 | 0.5184 | -0.1559, 1.2576 | | | 70 | 0.1108 | -0.4848, 0.7802 | | | 110 | -0.5412 | -2.0324, 1.0150 | K234088 - Page 13 of 16 {13} The sponsor also provided results from a study that demonstrated the accuracy is the same when operated by intended users at POC sites. 2. Matrix Comparison: Not applicable. The device is designed for use with human breast milk only. C Clinical Studies: 1. Clinical Sensitivity: Not applicable 2. Clinical Specificity: Not applicable 3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Not applicable D Clinical Cut-Off: Not applicable E Expected Values/Reference Range: The sponsor includes the following reference ranges in their labeling: Meta-analysis results of the macronutrient composition of term (37-42 weeks of gestation) human milk [1,2] | Time after delivery | Fat (g/dl) | | Protein (g/dl) | | Lactose (g/dl) | | Calories (Calculated) (kcal/dl) | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Mean | SD | Mean | SD | Mean | SD | Mean | SD | | Day 1-3 | 1.8 | 0.7 | 2.0 | 0.9 | 5.6 | 0.6 | 54* | 8.0 | | Day 4-7 | 2.6 | 0.8 | 1.6 | 0.3 | 6.0 | 1.0 | 68 | 9.6 | | Week 2 | 3.0 | 0.9 | 1.3 | 0.2 | 6.2 | 0.6 | 66* | 9.0 | | Week 3-4 | 3.4 | 0.8 | 1.1 | 0.2 | 6.7 | 0.7 | 70 | 9.3 | | Week 5-6 | 3.6 | 1.1 | 1.0 | 0.1 | 6.1 | 1.0 | 63* | 7.0 | | Week 7-9 | 3.4 | 0.8 | 0.9 | 0.1 | 6.5 | 0.5 | 69 | 9.9 | | Week 10-12 | 3.4 | 0.9 | 1.0 | 0.1 | 6.7 | 0.7 | 68 | 9.0 | K234088 - Page 14 of 16 {14} | Time after delivery | Fat (g/dl) | | Protein (g/dl) | | Lactose (g/dl) | | Calories (Calculated) (kcal/dl) | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Mean | SD | Mean | SD | Mean | SD | Mean | SD | | Colostrum (day 1-3) | 1.8 | | 2.0 | | 5.6 | | 54 | | | Mature milk | 3.4 | | 1.0 | | 6.5 | | 63 | | * Calories/Energy quantified using bomb calorimetry Meta-analysis results of the macronutrient composition of preterm (<37 weeks of gestation) human milk [1,2] | Time after delivery | Fat (g/dl) | | Protein (g/dl) | | Lactose (g/dl) | | Calories (Calculated) (kcal/dl) | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Mean | SD | Mean | SD | Mean | SD | Mean | SD | | Day 1-3 | 2.2 | 0.9 | 2.7 | 1.5 | 5.1 | 0.7 | 49* | 7.0 | | Day 4-7 | 3.0 | 1.2 | 1.7 | 0.5 | 6.3 | 1.1 | 65 | 13.0 | | Week 2 | 3.5 | 1.1 | 1.5 | 0.4 | 5.7 | 0.8 | 70 | 14.0 | | Week 3-4 | 3.5 | 1.0 | 1.4 | 0.4 | 6.0 | 0.5 | 68 | 8.0 | | Week 5-6 | 3.2 | -0.8 | 1.1 | 0.2 | 5.8 | 0.6 | 67 | 6.9 | | Week 7-9 | 3.3 | 0.9 | 1.1 | 0.2 | 6.3 | 0.4 | 66 | 8.9 | | Week 10-12 | 3.7 | 1.5 | 1.0 | 0.2 | 6.8 | 0.3 | 66 | 14.0 | | Colostrum (day 1-3) | 2.2 | | 2.7 | | 5.1 | | 49 | | | Mature milk | 3.3 | | 1.1 | | 6.2 | | 73 | | * Calories/Energy quantified using bomb calorimetry Macronutrient composition of donor human milk [4] | Reference | Fat (g/dl) | | Protein (g/dl) | | Lactose (g/dl) | | Calories (Calculated) (kcal/dl) | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Mean | Range | Mean | Range | Mean | Range | Mean | Range | | [4] | 3.2 | 1.2-5.2 | 1.2 | 0.7-1.7 | 7.8 | 6.0-9.6 | 65 | 43-87 | | [5] | 3.6 | 1.8-8.9 | 0.9 | 0.6-1.4 | 7.2 | 6.4-7.6 | 67 | 50-115 | K234088 - Page 15 of 16 {15} K234088 - Page 16 of 16 # References [1] D. Gidrewicz and T. Fenton. “A systematic review and meta-analysis of the nutrient content of preterm and term breast milk”, BMC Pediatrics 14:216, 2014 [2] K. Wojcik, D. Rechtman, M. Lee, A. Montoya, and E. Medo. “Macronutrient analysis of a nationwide sample of donor breast milk”. J Am Diet Assoc, vol. 109, pp. 137-140, 2009. [3] K. Michaelsen, L. Skafte, J. Badsberg, and M. Jorgensen. “Variation in macronutrients in human bank milk: Influencing factors and implications for milk banking”. Journal of Pediatric Gastroenterology and Nutrition, vol. 11, pp. 229-239, 1990. [4] Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002. PMID: 23178060; PMCID: PMC3586783. [5] Michaelsen KF, Skafte L, Badsberg JH, Jorgensen M. Variation in macronutrients in human bank milk: influencing factors and implications for human milk banking. Journal of pediatric gastroenterology and nutrition. 1990;11(2):229-239 [5] MIRIS HMA User Manual (https://www.mirissolutions.com/support/user-manuals) ## F Other Supportive Instrument Performance Characteristics Data: Information was provided to support equivalence between the claimed phones. ## VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. ## IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.