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The intended use of the AccuBase Arc Test Kit is for the determination of the relative percent (%) A16 (glycohemoglobin) in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC) as the analytical method. The AccuBase A1c Test Kit will be available to diabetes patients through physicians, pharmacies, diabetes supply and/or OTC distribution companies for the purpose of monitoring the average glucose ooncentration in the body over the past 30, 60 or 90 days including; a calculated Mean Blood Glucose (MBG) determination based on the DCCT MBG equation (31.7 X Arc % - 66.1) == MBG mg/dl as part of an comprehensive individual diabetes outcomes management, glycemic status assessment and treatment program. The AccuBasc Are Test Kit does not replace daily blood giucose monitoring. While there are no known contraindications, it is well known that the existence of disturbed erythrocyte kinetics conditions (such as anemia) many result in a non-reportable test result duc to too few Red Blood cells per volume of sample. A list of potential confounding factors are reported on the test result at time of reporting. Keep out of reach of children and pets. The intended reporting path of the AccuBase Ate test Kit test result include direct reporting to patients and/or a healthcare professional. Test results must be provided to a physician and/or healthcare professional for interpretation of specific A1e values and setting of specific target Air goals.

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The intended use of the Accu-Base Hemoglobin Arc Sample Indications for Use: Collection Kit is for the determination of the relative percent (%) hemoglobin Arc in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC)as the analytical method. The Accu-Base Hemoglobin Arc Sample Collection Kit will be available to patients through Point of Care Offices and/or Centers, for the purpose of monitoring individual, long-term diabetes control as part of a comprehensive diabetes management & treatment program. The Accu-Base Hemoglobin Arc Sample Collection Kit does not replace daily blood glucose monitoring. There are no known contraindications. Keep out of reach of children. The intended reporting path of the HbAic test results include direct reporting to the physician/health care professional responsible for the care of the individual for clinical interpretation including setting and interpreting specificHbArc target goals and test results. In addition the results may be reported to the patient.

The Accu-Base Hemoglobin Are Sample Collection Kit is packaged in two sizes or configurations designed for professional use. One kit is designed for patient take home use and is available in a one (1), two (2) and three (3) test kit configuration. The other, the (Point of Care Kit) is designed with ten (10) tests for in-office use. The Point of Care Kit is ideal for the physician's office, clinic, small hospital and/or diabetes clinic and/or laboratory. The at-home kit is designed to be used by qualified patients (physician discretion) in the privacy and convenience of their home. The at-home kit is designed to facilitate the collection, preparation, storage and transport of capillary (fingerstick) hemoglobin Are patient samples for laboratory analysis while providing empowerment and self-management training for the patient. The kit contains sufficient supplies and materials to collect either 1, 2 or 3 individual HbAic patient samples including: 1 durable self-contained shipper with built in labeled workstation. 1, 2 or 3 vials of (1 ml of hemolysis reagent), 1 capillary tube holder, 2-5 Na Heparinized 5ul capillary tubes (in labeled capillary dispenser) depending on the actual number of tests in the kit. 1-3 biohazard specimen bags with absorbent pads for airtight sample transport. 1-3 positive patient ID laboratory forms with peel off ID labels that are attached to the hemolysis vials (sample preparation vials). 1-3 sample mailers (pre-addressed/postage paid) to designated laboratory. Kit contents continued: 1 patient size HbAıc longitudinal tracking log. Product insert (Information & Instructions Booklet) 1 Mean Blood Glucose Monitoring Journal Toll free (24 hour) technical assistance line 888-872-2443 Note: Once the sample is collected and prepared, the Red Blood Cells (sample) Are hemolyzed. Schiff base removed and the sample is preserved for analysis and/or freezing for future analysis. in both cases, the finger, ear lobe or heal (pediatric patient/infants), is pierced (lanced) using a traditional sterile, disposable lancet device (SafeLet). The patient and/or care provider is instructed to lance the finger, wipe away the first drop, milk the finger toward the puncture site and collect the second drop of blood. A capillary tube is attached to a capillary tube and is filled with whole blood from the finger, the tube is filled from end to end (approximately 5ul of blood). The capillary tube is than wiped of any excess blood and placed in the open vial containing the hemolysis reagent. The vial is closed tightly and gently rotated to mix the sample with the hemolysis reagent (ensuring that all of the blood has transferred from the capillary tube to the surrounding reagent. (no blood or RED line will be visible in the tube once the vial has been properly mixed. The solution will be a heterogeneous light to dark pink color). The vial is labeled using the peel off label provided on the Patient Identification Form (sequenced number specific to that sample that are nonrepeating numbers). The lab form ID number corresponds to the vial number for positive ID at the laboratory. The labeled and mixed sample is placed in a biohazard bag, which also contains instructions for use to ensure proper sample processing. The bag is sealed using self-adhesive tape to ensure an airtight seal of the specimen during transport. The sealed biohazard bag is then placed in the sample mailer along with the lab ID form and closed with sealing tape to ensure safe undisturbed transport of the sample to the designated laboratory. The patient's sample can be dropped in the mail as soon as collected and prepared or placed in the refrigerator overnight if the sample is not going to be mailed the same day. The sample is stable for up to 14 days at room temperature and up to 21 days at refrigerated temperatures. The sample is considered pretreated and incubated when it arrives in the testing laboratory and can be immediately analyzed without any further treatment, dilution, elution or preparation. The lab verifies the patient name and ID number and performs the test using an automated Bio-Rad Laboratories HPLC instrument such as the MDMD™, Variant™ or Diamat™ system). The Point of Care (10 test kit), professional use kit is designed for low volume hospitals, clinical and large volume doctors offices. The kit includes sufficient supplies and materials to collect and process 10 samples. The kit includes patient chart size HbAıc tracking logs, The kits contain all of the supplies found in the smaller kits contained in a larger storage kit with the same printed instructions for use.