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The Home Access® A1C Test is an in vitro test method for the quantitative measurement of Hemoglobin A1c using capillary blood collected from the fingertip, collected onto filter paper via the Home Access collection cassette. The Home Access AIC Test is for measurement of HbA1c on blood specimens which can be collected at the patient's home or in a healthcare professional setting and delivered to the laboratory by mail. Measurements obtained through this method can be used for monitoring the long-term control of blood sugar (glucose) in people with diabetes. This test is not to be used to diagnose or screen for diabetes. Not for use on neonates.

The Home Access® A1C Test includes a micro-blood specimen collection kit. The collection kit is intended to facilitate in vitro laboratory testing of finger stick blood samples for a variety of clinical chemistry assays. This collection kit includes components needed to self-collect, package and mail a dried micro-blood sample to the certified clinical laboratory for testing. The collection kit is comprised of: - Blood Sample Collection Cassette - Sample Pouch - Sterile Safety Lancets (2) - Gauze Pad - Bandage (2) - Instructions for use - Prepaid Return Mailer - Patient Info Card - Outer Packaging

The accessa Cholesterol Panel is intended for in vitro, quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and calculated LDL-Cholesterol in dried micro-serum samples ("Cholesterol Panel"). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. The Cholesterol Panel is not intended for use on neonates. LDL-Cholesterol cannot be determined where the triglycerides value is greater than 400 mg/dL.

The accessa Cholesterol Panel incorporates the use of two separately regulated products. - The Home Access Micro Serum Specimen (MSS) Collection Kit (a Class I Medical Device listed with the FDA effective February 19, 2003, and manufactured under the Quality System Regulations) and - The Home Access Health Corporation (HAHC) Clinical Chemistry . Laboratory Lipid Profile Test Methods (Regulated under CLIA number 14D0981820). The Home Access Micro Serum Specimen Collection Kit ("MSS collection kit"), (Class I Medical Device CFR 21 Part 864.3250, registered February 19, 2003) is intended to facilitate in vitro diagnostic laboratory testing of fingerstick blood samples for a variety of clinical chemistry assays. This MSS collection kit includes a collection cassette, storage pouch and prepaid mailer along with all the materials necessary to self-collect a capillary blood sample into the blood collection/transportation cassette. The cassette is packaged along with patient/customer information and transported to the certified clinical laboratory for lipid profile testing. In its final configuration, the accessa Cholesterol Panel kit is comprised of: - . Blood collection/transportation cassette - Sample Return Pouch with Desiccant . - 2 Safety lancets ● - Gauze pad . - Adhesive bandage . - . Instructions for use - Brochure: "What you need to know to keep your heart healthy" . - Prepaid US Mail return mailer . - Informed Consent Form . - Outer Box . The patient/customer follows the directions to self-collect a capillary blood sample (approximately 100 micro liters), package and mail the sample to a certified clinical laboratory for analysis using FDA-cleared reagent and analysis systems. Once the dried sample is received in the laboratory, it is accessioned, labeled and eluted into a usable serum sample. Once eluted, the sample can be assaved as a diluted serum sample using US FDA-cleared reagents. All testing is done via the Roche Cobas Mira Plus chemical analyzer and utilizes the software approved for use in the testing instrument (K920402). The clinical laboratory is located at Home Access Health Corporation.