MICRODOT XTRA

{0}------------------------------------------------ #### 510(k) SUMMARY (k083273) 5. # 5.1 Purpose for Submission: Modification and addition to existing product. # 5.2 Analyte: NOV 1 9 2009 Whole blood Glucose # 5.3 Type of Test: Quantitative (electrochemical biosensor) # 5.4 Applicant: Cambridge Sensors Limited Units 9 & 10 Cardinal Park Godmanchester Huntingdon Cambs PE29 2XG United Kingdom # 5.5 Proprietary and names: microdot® Xtra Blood Glucose Monitoring system : blood glucose monitor microdot® Xtra Blood Glucose Meter consisting of three products microdof® Xtra Test Strips microdot® Control solutions # 5.6 Regulatory Information: - 1. Regulation section: 21 CFR § 862.1345, Blood Glucose Test System 21 CFR § 862. 1660, quality control material (assayed and un-assayed) - 2. Classification: Class II, Class I # 3. Product Code: NBW, Blood Glucose test system, over the counter LFR, Glucose Dehydrogenase, glucose JJX, Single (specified) analyte controls (assayed and unassayed) - 4. Panel: Clinical chemistry (75) {1}------------------------------------------------ ### 5.7 Intended Use ### Intended use(s): microdof® Xtra Blood Glucose Monitoring System microdot® Xtra Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. #### indication(s) for use: microdot ® Xtra Blood Glucose Monitoring System is intended for self testing of qlucose in capillary whole blood from a fingerstick by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus. #### microdor® Xtra Blood Glucose Meter The microdot® Xtra Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. #### microdot® Xtra Test Strips The microdot® Xtra Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. # microdot® Control solutions The microdot® Control solutions are intended for use with microdot® Xtra Blood Glucose Meter and microdot® Xtra Test Strips as a quality control check to verify the accuracy of the blood glucose test results. #### Special conditions for use statements(s): This product is intended for over-the-counter and point-of-care use. Special instrument requirements: microdot® Blood Glucose Meter ### 5.8 Device Description: The microdot® Xtra Blood Glucose Monitoring System consists of the microdot® Xtra Blood Glucose Meter, microdot® Xtra Test Strips, microdot® Control Solutions and a commercially available (510(k) cleared) lancing device and lancets. {2}------------------------------------------------ The microdot® Xtra Blood Glucose Monitoring System is intended for invitro diagnostic use and for the quantitative measurement of glucose in fresh capillary whole blood. The modified device ie microdor® Xtra Blood Glucose Monitoring System, and its predicate device, microdot® Blood Glucose Monitoring System are intended for use by persons with diabetes or by healthcare professionals in home settings or healthcare facilities. The modified microdot® Xtra Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system. The microdot® Xtra Blood Glucose Monitoring System relies on quantitative electrochemical biosensor technology to measure current generated on disposable test strips. The strip remains unchanged since the last submission approval, microdot® Blood Glucose Monitoring System (k070524). The Test Strip manufacturing and performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose in fresh capillary blood from the fingertip by persons with diabetes or by healthcare professional in home or healthcare facilities. Both the predicate strips, microdor® Test Strips (k070524) and the microdot® Xtra Test Strips use the reagent qlucose dehydrogenase with nicotinamide-adenine dinucleotide as co-factor. The predicate meter uses lot specific calibration code number marked on the strip vial label. The specific code number on the strip vial label allows the meter to convert electrical current into glucose readings via the embedded software in the meter. The user calibrates their meter each time they open a new vial of strips. Each lot of strips is calibrated to give plasma equivalent glucose readings. The meter is turned on by strip insertion, the user applies a drop of blood or control solution to the test strip and the meter starts the measurement. After 10 seconds, the meter displays the glucose concentration and time and date on the LCD display. The microdot® Xtra Blood Glucose Monitoring System is pre-programmed with a predetermined code number, thus removing the requirement to load a code number specific to the strip vial. ### 5.9 Substantial Equivalence Information: Predicate device name (s): microdot® Blood Glucose Monitoring System Predicate 510(k) number: k070524 Comparison with predicate: {3}------------------------------------------------ microdot® and microdot® Xtra Test Strips share the same design, functionality, raw materials and manufacturing process. | Product Name | microdot® Xtra | microdot®<br>(K070524) | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Characteristic/aspect | Auto Code System | Code entered<br>according to new<br>value on strip vial | | Intended Use | Blood glucose<br>monitoring for home<br>and point of care | Same | | Sample | Fresh Capillary<br>whole blood | Same | | Test Principle | Electrochemical<br>Biosensor | Same | | Calibration | Plasma equivalent | Same | | Sample volume | 600nanoliters | Same | | Temperature and<br>humidity range | 10°- 40°C<br>10-90% RH | Same | | Control Solutions | 3 levels | Same | | Color | Blue | Same | | Fill Volume | 4 ml | Same | | Matrix | Buffered aqueous<br>solution of D-<br>glucose, viscosity<br>modifier,<br>preservatives and<br>other, non-reactive<br>ingredients | Same | | Stability | Strips and controls,<br>3 months after<br>opening | Same | # Comparison to Predicate Device: {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002 Cambridge Sensors Limited c/o Ms. Bernadette Yon-Hin Units 9 & 10 Cardinal Park Godmanchester Huntingdon, Cambridgeshire United Kingdom PE29 2XG NOV 1 9 2009 Re: k083273 Trade Name: Microdot® Xtra Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Blood Glucose Test System Regulatory Class: Class II Product Codes: NBW, LFR, JJX Dated: October 5, 2009 Received: October 9, 2009 Dear Ms. Yon-Hin: 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {5}------------------------------------------------ #### Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, CA Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indication for Use 510(k) Number (if known): (k083273) Device Name: microdot Xtra® Blood Glucose Monitoring System microdot Xtra® Blood Glucose Monitoring System The microdot Xtra Blood Glucose Monitoring System is intended for self test use outside the body (in vitro diagnostic use only). It should be used only for testing fresh capillary whole blood samples from a fingerstick for glucose (sugar). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus. #### indication(s) for use: microdot Xtra® Blood Glucose Monitoring System The microdot Xtra 8 Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood from a fingerstick by persons with diabetes or by health care professionals in home settings or healthcare facilities. microdot Xtra® Blood Glucose Meter The microdot Xtra ® Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. microdot Xtra® Test Strips The microdot Xtra® Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. microdof® Control solutions The microdot® Control solutions are intended for use with microdot Xtra Blood Glucose Meter and microdot Xtra Test Strips as a quality control check to verify the accuracy of the blood glucose test results. Over the Counter Use YES Prescription Use And/Or (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Dixision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 1<083273