PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY

{0}------------------------------------------------ Modified Precision Xtra/MediSense Optium Blood Glucose Test Strip Neonatal, venous and arterial claims Volume I of I 510(k) Notification 13-June-2002 #### Summary of Safety and Effectiveness K021960 Submitted by: Janet Connolly, RAC Senior Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, MA 01730-6230 Device Name: Precision/Optium Point of Care Blood Glucose Test Strips with True Measure Technology Common Name: Reagent Blood Glucose Test Strip Classification: Glucose Test System Class II per 21 CFR 862.1345 Predicate Device: Accu-Chek Comfort Curve Test Strip K980731 Description: The Precision/Optium Point of Care Blood Glucose Test Strips with True Measure Technology is to be used for blood glucose testing with the Precision Xtra/Optium and Precision PCx Blood Glucose Meters. These systems utilize amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in fresh whole blood and control solutions. Intended Use: The Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology is intended for in vitro diagnostic use. The test strip quantitatively measures glucose (D-glucose) in fresh venous. arterial, neonatal, and fingertip capillary whole blood. The test strip is indicated for use by health care professionals in health care settings, > This strip may be used with the Precision Xtra/Optium Blood Glucose Meters. #### Comparison to The Precision/Optium Point of Care Blood Glucose Test Strip has Predicate Device: similar technological characteristics as the predicate device, Accu-Chek Comfort Curve Test Strip K980731. {1}------------------------------------------------ | Performance<br>Studies: | The performances of the Precision/Optium Point of Care Blood<br>Glucose Test Strip with True Measure Technology was studied in the<br>laboratory and in clinical settings by healthcare professionals. The<br>studies demonstrated that healthcare professionals could obtain blood<br>glucose results that are substantially equivalent to a comparative<br>method. | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion: | Results of laboratory and clinical testing demonstrate that the<br>performance of the Precision/Optium Point of Care Blood Glucose<br>Test Strips when used according to the intended use stated above is<br>acceptable and comparable to the performance to a comparative<br>method. | {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three wing-like shapes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. # AUG 1 6 2002 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Janet Connolly, RAC Sr. Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, MA 01730-1402 Re: k021960 > Trade/Device Name: Abbott Laboratories, MediSense Products Precision Point of Care Blood Glucose Test Strips with True Measure Technology Abbott Laboratories, MediSense Products Optium Point of Care Blood Glucose Test Strips with True Measure Technology Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR Dated: June 13, 2002 Received: June 14, 2002 Dear Ms. Connolly: 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 stated in the enclosure) 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) 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. If 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply 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. {3}------------------------------------------------ Page 2 - 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 predicate device results in a classification 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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsmaldsmamain.html". Sincerely yours, Steven Putman 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 {4}------------------------------------------------ ## INDICATIONS FOR USE FORM 510(k) Number (if known): Abbott Laboratories, MediSense Products Precision Point of Care Device Name: Blood Glucose Test Strips with True Measure Technology. > Abbott Laboratories, MediSense Products Optium Point of Care Blood Glucose Test Strips with True Measure Technology ### Indications For Use: The Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology is intended for in vitro diagnostic use. The test strip quantitatively measures glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood. The test strip is indicated for use by health care professionals in health care facilities. The test strip is to be used for monitoring diabetes mellitus. This strip may be used with the Precision Xtra and Optium meters. Nherts Znting for Jean Cooper Division Sign Off vision of Clinical Laboratory Devices 510(k) Number # (PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Or Prescription Use (Per 21 CFR 801.108) Over-The-Counter Use