MICRODOT & MICRODOT XTRA

{0}------------------------------------------------ 510(k) Summary # K102383 Purpose for Submission: Addition of Palm testing (alternate site) to existing product. Analyte: Whole blood Glucose Type of Test: Quantitative (electrochemical biosensor) Applicant: Cambridge Sensors.Limited Units 9 & 10 Cardinal Park Godmanchester Huntingdon Cambs PE29 2XG United Kingdom Contact Name: Dr. Bernadette Yon-Hin Date: 24th January 2012 Proprietary and names: microdot® Home Blood Glucose Monitoring system : microdor® Home Blood Glucose Meter microdot® Home Test Strips consisting of three products microdot® Control solutions # Regulatory Information: Regulation section: 21 CFR § 862.1345, Blood Glucose Test System Classification: Class II, Class I Product Code: NBW, Blood Glucose test system, over the counter LFR, Glucose Dehydrogenase, glucose Panel: Clinical chemistry (75) #### Intended Use Intended use(s): See indication(s) for use below Cambridge Sensors Limited {1}------------------------------------------------ ### Indication(s) for use: The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus. The system consists of the microdot Home Blood Glucose meter, microdot 8 Home Test Strips and microdot® Control solutions. # microdot® Home Test Strips The microdot 8 Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm. # Special conditions for use statements(s): This product is intended for over-the-counter. Fingerstick testing only (no palm testing) should be performed if blood glucose level is changing rapidly as follows: - Within 2 hours after a meal ◆ - Within 2 hours after insulin dosing . - Patients with a history of hypoglycaemia, experiencing symptoms of low sugar or suffer from hypoglycaemic unawareness. #### Special instrument requirements: microdot® Home Blood Glucose Meter #### Device Description: The microdot® Home Blood Glucose Monitoring System consists of the microdot® Home Blood Glucose Meter, microdote Home Test Strips, microdot Control Solutions and a commercially available (510(k) cleared) lancing device and lancets. A clear cap is provided with the lancing device for alternate site testing on the palm. microdote Home Blood Glucose Monitoring System is for a single patient use only. The meter and lancing device must not be shared with anyone. microdot® Home is an auto code system. The meter turns on upon insertion of the strip, a blood sample from the finger or palm is applied to the test strip and after 10 seconds, the plasma glucose result is displayed on the screen in mg/dL only. microdot Home Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system, microdot® Xtra Blood Glucose Monitoring System. It relies on quantitative Cambridge Sensors Limited Page 2 of 5 {2}------------------------------------------------ ### 510(k) Summary electrochemical biosensor technology to measure current generated on disposable test strips. The strip remains unchanged since the last submission approval, microdot® Xtra Blood Glucose Monitoring System (k083273). 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. #### Substantial Equivalence Information: ### Predicate device name (s): microdot® Blood Glucose Monitoring System, 510(k) Number :k070524 microdot® Xtra Blood Glucose Monitoring System, 510(k) Number:k083273 Comparison with predicate: microdot® Home Test Strips share the same design, functionality, raw materials and manufacturing process as. microdof® Xtra Test Strips. | | Device 1 | Predicate 1 | Predicate 2 | |-----------------------------------|--------------------------------|---------------------------------------|-----------------------------| | Product Name | microdot® Home | microdot®<br>(k070524) | microdot® Xtra<br>(k083273) | | Code | No code number | Code Number for<br>each lot of strips | No code number | | Enzyme | Glucose<br>Dehydrogenase/NAD | Same | Same | | Sample | Fresh Capillary whole<br>blood | Same | Same | | Blood Source | Finger, Palm | Finger | Finger | | Test Principle | Electrochemical Biosensor | Same | Same | | Calibration | Plasma equivalent | Same | Same | | Sample volume | 600nanoliters | Same | Same | | Temperature and<br>humidity range | 10°- 40°C<br>10-90% RH | Same | Same | | Hematocrit range | 30-50% | Same | Same | | Measurement<br>Range | 25 - 525 mg/dL | Same | Same | | Control Solution | Low, Normal, High | Same | Same | #### Comparison to Predicate Devices: # Standard/Guidance Document referenced (if applicable): ISO15197:2003: in vitro diagnostic test systems- requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus (Section 8: User Performance) #### Test Principle Cambridge Sensors Limited {3}------------------------------------------------ 510(k) Summary The test is based on the enzymatic conversion of glucose in the sample to gluconolactone, with concomitant reduction of the enzyme cofactor NAD* to NADH. The NADH is re-oxidised to NAD* by the mediator compound which in turn becomes reduced; re-oxidation of the mediator by the meter induces a micro current to flow, and the size of this micro current is directly proportional to the amount of glucose in the sample. Unlike PQQ dependent Glucose Dehydrogenase, the NAD-dependent Glucose Dehydrogenase enzyme used in the microdor® Home test strips is specific to glucose and has no interference from galactose and maltose. # Performance Characteristics 1. Analytical Performance Precision/ Reproducibility Established in original submission (k070524) Linearity/assay reportable range Established in original submission (k070524) Traceability, Stability', Expected values (controls, calibrators, or methods) Established in original submission (k070524) Detection Limit Established in original submission (k070524) Analytical Specificity · Established in original submission (k070524) Assay Cut-off Not applicable 2. Comparison Studies Comparison with predicate device Established in original submission (k070524) Alternate Site Testing at Palm A consumer study was performed with 152 diabetics testing themselves both at finger and alternate site and healthcare professionals testing at finger only to see if the results obtained at the alternate site is comparable with the finger. The diabetics obtained the samples and carried out the tests using the instructions provided. The samples ranged from 48 to 367 mg/dL. The palm results were comparable to finger results. Cambridge Sensors Limited Page 4 of 5 {4}------------------------------------------------ | Summary of Accuracy Results for all sites tested | | | | |--------------------------------------------------|------------------------------|--------------------|--------------------| | Sites tested | For glucose levels < 75mg/dL | | | | | Within +/- 5mg/dL | Within +/- 10mg/dL | Within +/- 15mg/dL | | * Subject Palm Accuracy vs YSI | 0 (3) 0% | 2 (3) 67% | 3 (3) 100% | | Subject finger Accuracy vs YSI | 1 (3) 33% | 3 (3) 100% | 3 (3) 100% | | HCP finger. Accuracy vs YSI | 1 (3) 33% | 3 (3) 100% | 3 (3) 100% | | Summary of Accuracy Results for all sites tested | | | | | | |--------------------------------------------------|-----------------------------|---------------|----------------|----------------|----------------| | Sites tested | For glucose levels ≥75mg/dL | Within +/- 5% | Within +/- 10% | Within +/- 15% | Within +/- 20% | | Subject Palm Accuracy vs YSI | | 61 (149) 41% | 109 (149) 73% | 134 (149) 90% | 146 (149) 98% | | Subject finger Accuracy vs YSI | | 76 (149) 51% | 121 (149) 81% | 138 (149) 93% | 144 (149) 97% | | HCP finger Accuracy vs YSI | | 62 (149) 42% | 116 (149) 78% | 138 (149) 93% | 146 (149) 98% | #### 3. Disinfection Studies Dispatch Hospital Cleaner Disinfectant wipes with Bleach with EPA registration # 56392-8 was validated demonstrating complete inactivation of Hepatitis B virus. It was demonstrated that there was no change in performance or in the external materials of the meter and lancing device for a minimum of 375 cycles equivalent to a pre-clean and disinfection cycle of once per week for 5 years for a single patient use only meter. # Conclusion The study supports substantial equivalence to a predicate device and the addition of palm testing as an alternate testing site for blood glucose testing. Cambridge Sensors Limited {5}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, possibly symbolizing health and well-being. #### Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 CAMBRIDGE SENSORS LIMITED c/o Dr. Bernadette Yon-Hin Units 9 & 10 Cardinal Park Godmanchester Huntingdon, Cambridgeshire United Kingdom PE29 2XG JAN 2 7 2012 k102383 Re: Trade Name: microdot® Home Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, LFR Dated: January 5, 2012 Received: January 9, 2012 Dear Dr. 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 Eederal 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). {6}------------------------------------------------ # 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/Medical Devices/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 Tou may 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, signature Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indication for Use # 510(k) Number (if known): k102383 Device Name: microdot® Home Blood Glucose Monitoring System Indication for Use: The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus. The system consists of the microdot® Home Blood Glucose meter, microdot® Home Test Strips and microdot® Control solutions. # microdot® Home Test Strips The microdot® Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm. Over the Counter Use YES And/Or Prescription Use (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 (OVD) Signature Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 102383