The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma or whole blood at a level equal to or higher than 1 ng/mL. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite Troponin I Combo Rapid Test is intended to be used by healthcare professionals as an aid in the diagnosis of acute myocardial infarction (AMI). Any use or interpretation of this preliminary test result must also rely on patient’s symptoms and the professional judgment of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device. Normally the level of cTnI in the blood is very low. cTnI is released into the blood stream in forms of free cTnI and cTnI-C-T complex at 4-6 hours after myocardial cell damage. The elevated level of cTnI could be as high as 50 ng/mL during 60-80 hours after AMI and remains detectable for up to 10-14 days post AMI. Therefore, circulating cTnI is a specific and sensitive marker for AMI. Clinical performance: Relative Sensitivity: 95.8% (95% CI: 91.5-97.9%) compared to a reference CLIA Relative Specificity: 99.7% (95% CI: 98.8-99.9%) Analytical sensitivity: The detection limit of cTnI is 1.0 ng/mL or greater in serum, plasma or whole blood specimen Cross-reactivity: No cross reactivity with 10 µg/mL skeletal muscle TnI, 2,000 ng/mL cardiac muscle TnT, 20 µg/mL cardiac muscle Myosin Dose hook effect: No hook effect was observed for cTnI at concentrations up to 3,521 µg/mL Interference: No interference was seen with 20 mg/dl Acetaminophen, 20 mg/dl Acetylsalicylic acid, 10.5 g/dl Albumin, 20 mg/dl Ascorbic acid, 1,000 mg/dl Bilirubin, 20 mg/dl Caffeine, 800 mg/dl Cholesterol, 200 mg/dl Creatinine, 20 mg/dl Gentistic acid, 1,000 mg/dl Hemoglobin, 600 mg/dl Oxilic acid, 1,600 mg/dl Triglycerides Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample diluent (REF SB-R3002, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Insert MedlinePlus: Troponin Test Poster

INTENDED USE The Finecare™ One Step cTn I/CK-MB/Myo Rapid Quantitative Test a fluorescence immunoassay to be used along with Finecare™ FIA System for quantitative determination of cardiac Troponin I (cTn I), MB Isoenzyme of Creatine Kinase (CK-MB) and Myoglobin (Myo) in human whole blood, serum or plasma. The test is used as an aid to the diagnosis of myocardial infarction. STORAGE AND STABILITY 1. Store Finecare™ One Step cTn I/CK-MB/Myo Rapid Quantitative Test at 4 ℃~30 ℃. Do not freeze. Shelf life is up to 24 months, refer to label for expiration date 2. If removed from refrigeration, allow the Test Cartridge for 30 minutes to reach room temperature (25±2℃) before testing. 3. Once opened, commence to use the Test Cartridge within an hour. 4. Do not remove the device from the pouch until ready to use. Keep the Test Cartridges away from light.

INTENDED USE The Finecare™ cTn I/NT-proBNP Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of cardiac Troponin I (cTn I) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of myocardial infarction and suspected congestive heart failure. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

Troponin-I WHOLE BLOOD RAPID TEST For Qualitative Detection of Troponin-I Whole Blood Rapid Test Type : Device Pack Size : 25 T

Oscar Troponin-I is an in vitro diagnostic test based on immunochromatographic assay. It is designed for qualitative determination of Cardiac Troponin-I (cTnI) in human serum / plasma as an aid in the diagnosis of acute myocardial infarction (AMI). For professional and in-vitro diagnostic use only. Pack Size: 10 Tests

INTENDED USE The Finecare™ Vitamin D Rapid Quantitative Test along with Finecare™ FIA Meter is a fluorescence immunoassay quantitative determination of total 25(OH) D2/D3 level in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency. STORAGE AND STABILITY 1. Store at 4°C～30°C up to the expiration date. 2. The solid marker bottle can be stored at 2°C～8°C for 28 days after being reconstituted. 3. Do not remove the device from the pouch until ready to use. The Test Cartridges should be used within 1 hour once opened.

Cortisol Rapid Quantitative Test The Finecare™ Cortisol Rapid Quantitative Test is a fluorescence immunoassay for quantitative determination of Cortisol in human serum, plasma or whole blood. The test is used as an aid to the screening of adrenal dysfunction and assessment of the treatment effect. STORAGE AND STABILITY 1. Store the test kit at 4~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the test cartridge from the pouch until use. The test cartridge should be used within 1 hour once opened.

INTENDED USE The Finecare™ Ferritin Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative determination of Ferritin in human whole blood, serum or plasma. The test is used as an aid to the assessment of iron deficiency anemia. STORAGE AND STABILITY 1. Store the test kit at 4 ~30℃ up to the expiration date printed on the package. 2. Do not remove the Test Cartridge from the pouch until ready to use. The Test Cartridge should be used within 1 hour once opened.

INTENDED USE The Finecare™ S100β Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative determination of S100β in human serum, plasma or whole blood. The test is used as an aid to the assessment of the level of cerebral injury. STORAGE AND STABILITY 1. Store the test kit at 4 ~ 30 ℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.