ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT

K013465 · Diabetes Technologies, Inc. · LCP · Jan 22, 2002 · Hematology

Device Facts

• Record ID: K013465
• Device Name: ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
• Applicant: Diabetes Technologies, Inc.
• Product Code: LCP · Hematology
• Decision Date: Jan 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

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.

Device Story

AccuBase A1c Test Kit measures glycohemoglobin (A1c) in capillary whole blood samples via high-performance liquid chromatography (HPLC). Device intended for diabetes patients to monitor long-term glycemic control; provides calculated Mean Blood Glucose (MBG) using DCCT equation. Available via physicians, pharmacies, or OTC. Patients collect samples; results reported to patients and healthcare professionals. Interpretation of A1c values and target goal setting requires physician oversight. Does not replace daily glucose monitoring. Confounding factors (e.g., anemia) flagged in reports.

Technological Characteristics

Analytical method: High Performance Liquid Chromatography (HPLC). Analyte: Glycosylated Hemoglobin (A1c). Sample type: Capillary whole blood.

Indications for Use

Indicated for diabetes patients for monitoring average glucose concentration over 30, 60, or 90 days using capillary whole blood. Contraindications: none known, but disturbed erythrocyte kinetics (e.g., anemia) may cause non-reportable results.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Arthur G. Williams Applicant/Chief Scientific Officer Diabetes Technologies, Inc. 216 West Jackson Street Thomasville, Georgia 31792

JAN 2 9 2002

Re: K013465

Trade/Device Name: Accu-Base A12 Test Kit Regulation Number: 21 CFR § 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: II Product Code: LCP Dated: November 8, 2001 Received: November 15, 2001

Dear Mr. Williams:

This letter is to correct the letter sent on January 22, 2002, regarding the device name change from Accu-Base Hemoglobin Ap Sample Collection Kit to Accu-Base An Test Kit. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use above and have losure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act (Act that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

1f your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I Dr I intended on for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific davices it devices), please contact the Office of Compliance at additionally 607.10 for in The carguestions on the promotion and advertising of your device, (2017 594-4500. Trace at [phone]. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mountacturers International and Consumer Assistance at its toll-free number [phone] or Manufacturers international and Selecss "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Intended Use

K013465

Trade/Device Name: AccuBase Arc Test Kit

510 {k} (if known):

Indications for Use.

The intended use of the AccuBase Are 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.

Josephine Bautista

510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE)

Prescription Use

or Over-The Counter Use