## Materials and Methods  
The elemarkTM lipid check device was developed in September 2016 as a self-testing cholesterol measuring device. TC, HDL, and TG were measured using elemarkTM compatible cholesterol test strips. The elemarkTM System includes the elemarkTM Analyzer and the SD LipidoCareTM lipid test strip (Figure 1). The system is operated on a lithium-ion battery (3000 mAh), providing 2G (850/900/1800/1900), 3G (850/900/1900/2100), 4G (800/850/1700/1800/2100/2600), Wi-Fi (802.11 b/g/n), and Bluetooth (V4.0) connectivity. The dimensions of the device are 159 mm \(\times\) 81 mm \(\times\) 9.5 mm, with a 5.5 inch HD display and a weight of 193 g. The system runs on AndroidTM OS, an MT6735P processor, and 32 GB ROM/3 GB RAM memory. The test time duration was 3 min and a 35 uL blood sample was required. The detection ranges of TC, TG, and HDL were 100-450 mg/dL, 45-650 mg/dL, and 25-95 mg/dL, respectively. This experiment was approved by the Incheon St. Mary's Hospital Institutional Review Board (IRB) in Incheon, South Korea (OC16 SISI0139), and complied with the World Medical Association Declaration of Helsinki regarding ethical conduct of research involving human subjects. We followed the experimental procedures described in the normative references for the application of the International Organization for Standardization (ISO) [6, 7]. We recruited normal participants (20-80 years of age) from the local community in Incheon, South Korea. All participants were given thorough explanations  
Figure 1: Device components. (**A**) elemarkTM, (**B**) elemarkTM lipid check, (**C**) elemarkTM lipid check cholesterol test strip, (**D**) connection of the elemarkTM lipid check to a compatible mobile device in the shown direction, (**E**) button is pushed up to lock the elemarkTM lipid check. about the experiment and they all gave written informed consent. We anonymized the identity of the sample sources. Because it was a simple blood test, the risk of the sample supplier was minimized. Minimal risk is defined as the degree and severity of harm or discomfort that may arise from studies not greater than the daily life of a healthy person or a routine physical or psychological examination [8]. The test temperature was controlled at 20-26 \({}^{\circ}\)C during the experiment. The AU5800 Analyzer (Beckman Coulter Inc., IN, USA) was used as the reference device. Total cholesterol (TC), triglyceride (TG), and high-density lipoprotein (HDL) were measured and reported. Low density lipoprotein (LDL) was calculated as TC-HDL-TG/5. LDL was not reported in this evaluation study. The elemarkTM cholesterol meter was stored at -30 \({}^{\circ}\)C to 70 \({}^{\circ}\)C, with a relative humidity of 90% or less and an altitude of less than 2000 m. The cholesterol test strips (SD Biosensor LipidCare Lipid Profile Strips) were stored at room temperature between 2 \({}^{\circ}\)C and 32 \({}^{\circ}\)C and were used immediately after the individual pouches were opened. The venous whole blood in the treated ethylenediaminetetraacetic acid (EDTA) tube was used for elemarkTM and the venous serum blood in the treated EDTA tube was separated from the venous whole blood and used in the reference device (AU5800). We recruited 116 participants for a blood test (80 women, 36 men, 70.8 \(\pm\) 10.8 years) (Table 1). Samples were tested and analyzed within one day of blood collection. The comparison results between elemarkTM and AU5800 were analyzed. A correlation coefficient was used to evaluate the correlation between the two measurements (Figure 2). [PERSON]'s fences were used to identify outliers based on interquartile range. The interquartile range is a measure of the statistical variance and is equivalent to the difference between the 75 th and 25 th  
Figure 2: Test procedure. (**A**) Tap on the cholesterol icon to launch the app. (**B**) Press the Start Test button. (**C**) Use the camera of the mobile device to scan the barcode in the strip box. Once the cholesterol test strip is validated, the app automatically goes to the next step.