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The Appraise-Cardio sample collection kit is a prescription device indicated for use for obtaining a blood specimen which can be collected at the patient's home or at a physician's office in a sample collection tube and delivered to the laboratory by mail. This specimen is then used to determine the patient's total cholesterol, triglycerides, HDL and LDL values. The results are then mailed to the patient's physician for evaluation.

The Appraise-Cardio Sample Collection Kit is a Sample Collection Kit which is sent to the patient's home after the kit has been ordered by the patient's physician. The kit consists of the following: - A Sample Collection Tube. - - A Sample Collection Capillary Tube. - - -A Sample Tube Holder Box. - A Patient Identification Card which contains the patient's name, address, Social Security Number, t information, the physician's name and phone number and a bar code number that is peeled off and affixed to the Sample Collection Tube after the sample has been taken. - A pamphlet containing detailed information about the lipid program and instructions on how to obtain a blood sample and mail it to a laboratory. - A plastic zip lock bag marked "Specimen Collection Envelope" into which the Sample Collection Tube is placed. - An absorbent pad that is contained in the Specimen Collection Envelope. - - A plastic zip lock bag marked "Waste". - - A self-adhesive envelope in which the specimen envelope is inserted and then mailed to the preprinted address on the envelope. - -A sterile lancet - -An alcohol swab - A sterile gauze pad - - -A sterile adhesive bandage - The mailing envelope which is used to mail the above items to the patient. . The Sample Collection Tube, Sample Collection Capillary Tube, lancet, alcohol swab, gauze pad and adhesive bandage are all legally marketed, commercially available items. After receiving the Appraise-Cardio Sample Collection Kit in the mail, the patient then collects a blood sample, using a lancet supplied in the kit or purchased separately by the patient. The blood sample is placed in the Sample Collection Tube as described in the instructions. The bar code sticker from the Patient Identification Card is then affixed to the Sample Collection Tube which is then placed in the Specimen Collection Envelope. The Patient Information Card and Specimen Collection Envelope are then placed in the mailing envelope. The mailing envelope is then sealed and sent to a laboratory for processing. When the blood sample is received by the laboratory the patient's total cholesterol, triglycerides and HDL values are measured using existing reagent kits.

The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus.

The HemoChek-A1c Sample Collection Kit is a kit which is purchased by a patient a pharmacy or other retail store. The kit consists of the following: - A Sample Card containing the proprietary filter paper that the blood sample is placed on and a place for the patient to print his/her name, address, social security number and the sample was collected - A pamphlet containing detailed instructions about how to obtain a blood sample and mail it to Osborn -Group, Inc. - A specimen envelope with the words "After blood has dried, insert completed HemoChek test in this envelope. Seal flap and place in envelope" printed on it - A self-adhesive envelope in which the card is inserted and then mailed to Osborn Group, Inc. - - A sterile lancet - - An alcohol swab - - A gauze pad - - An adhesive bandage - - -An outer package containing all of the items listed above After purchasing the HemoChek-A1c Sample Collection Kit, the patient then prints the required information on the Sample Card and collects a blood sample, using a lancet (either the one provided in the kit, one provided by the patient's physician or one supplied by the patient). The blood sample is placed on both circles on the right hand side of the Sample Card, as described in the instructions. The Sample Card is then placed in the specimen envelope which in turn is placed in the mailing envelope provided in the kit and mailed to Osborn Group, Inc. When the blood sample is received by Osborn Group, Inc., the patient's HbA1c level is measured using existing assay methods. The results are then mailed to the patient.

The HemoChek Urine Collection Kit is a prescription device intended to collect a urine specimen in midstream or by dipping the absorbent pad in a cup containing urine, contain the specimen, and preserve the specimen after collection and during mailing from the collection area to the laboratory for testing of creatinine and microalbumin concentrations.

The HemoChek Urine Collection Kit is a device used by a person under the supervision of a trained health care professional to obtain a urine specimen midstream or by dipping the absorbent pad in a cup of urine, contain the specimen, and preserve the specimen after collection and during mailing to the laboratory for testing of creatinine and microalbumin concentrations. The device consists of the following: - A collector pad holder/handle with a collector pad and a protective cover over the pad, contained in a sealed "peel-apart" plastic envelope. The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a sufficient amount of urine has been collected. - A Specimen Tube with a screw-on lid, containing preservative fluid. - A clear plastic sealed envelope that contains both of the above items. - A Patient Identification Card which contains the patient's name, address, Social Security Number, Insurance information, the Doctor's name and a bar-coded label which is peeled off and attached to the Collection Tube after the sample has been taken. - A set of instructions. - A zip lock bag into which the Specimen Tube is placed after the sample has been taken. - A mailer into which the zip lock bag is placed. - A polyethylene mailing envelope which contains all of the above items and is used to mail the HemoChek Urine Collection Kit to the patient.