MICRODOT BLOOD GLUCOSE MONITORING SYSTEM

K070524 · Cambridge Sensors Limited · NBW · Jun 22, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070524
• Device Name: MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Cambridge Sensors Limited
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The microdot® Blood Glucose Monitoring System is intended to measure glucose in whole capillary blood by persons with diabetes or by health care professionals in the home or in health care facilities. microdot Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only. The microdot Blood Glucose Meter is intended for the quantitative measurement r fromlers 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. It is intended for monitoring of blood glucose levels only. The microdot Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by o grassowith diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only. miorodot oontrol solutions are intended for use with microdot Blood Glucose Meter and microdot Test Strips as a quality control check to verify the accuracy of the blood glucose test results.

Device Story

System measures glucose in fresh capillary whole blood; requires fingerstick sample. User inserts test strip into meter; applies blood drop. Glucose dehydrogenase enzyme converts glucose to gluconolactone; reduces NAD+ to NADH. Mediator compound re-oxidizes NADH; re-oxidation induces micro-current proportional to glucose concentration. Meter displays result after 10 seconds. Used in home or clinical settings by patients or healthcare professionals. Manual calibration code entry required via meter buttons. Provides quantitative glucose monitoring to assist diabetes management.

Clinical Evidence

Clinical study with 121 diabetic patients comparing microdot system to YSI reference method. Results: regression equation y=1.0055x + 0.7776, r=0.982. Comparison to predicate (One Touch Ultra) showed r=0.988. Non-clinical bench testing included linearity (20-520 mg/dL, r=0.996), within-run precision (CVs 2.9%-5.48%), and hematocrit interference testing (30-50% range).

Technological Characteristics

Glucose dehydrogenase enzymatic assay; electrochemical sensing (micro-current). Dimensions/form factor: handheld meter. Connectivity: none. Sterilization: not applicable. Software: embedded firmware for signal processing and display. Calibration: manual code entry via meter buttons. Operating range: 10°C to 40°C; 10% to 90% relative humidity.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingersticks. Intended for use by persons with diabetes or healthcare professionals in home or clinical settings for monitoring blood glucose levels.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• One Touch Ultra blood glucose monitoring system (k002134)
• Senova Blood Glucose monitoring system (k032076)
• Senova control solutions (k032819)

Submission Summary (Full Text)

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# Summary for Public Disclosure

K070524

| Applicant: | Cambridge Sensors Ltd.<br>Units 9 and 10,<br>Cardinal Park,<br>Godmanchester, Huntingdon,<br>Cambridgeshire, PE29 2XG<br>United Kingdom | JUN 2 2 2007 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Dr. Bernadette Yon-Hin | |
| Date Summary Prepared: | 9th January 2007 | |
| Device Trade Name: | microdot® Blood Glucose Monitoring System | |
| Common Name: | Self Monitoring Blood Glucose Test | |
| Classification Name: | Whole blood glucose test | |
| Equivalent Device: | LifeScan Ultra Blood Glucose System | |
| Device Description: | The microdot® Blood Glucose System is<br>comprised of the microdot® Meter, Test Strips,<br>& three controls. The test strip is inserted into<br>the device, a drop of blood is added to the strip,<br>and a glucose result is presented in 10<br>seconds.<br><br>The test principle is based on electrochemical<br>biosensor technology. Glucose dehydrogenase<br>converts to glucose to gluconolactone, with<br>reduction of NAD to NADH. Re-oxidation of the<br>mediator by the meter induces a micro current<br>to flow, and the size of the micro current is<br>directly proportional to the amount of glucose<br>in the blood. The micro current is detected in of<br>the blood glucose concentration. | |
| Intended use: | The microdot® Blood Glucose Monitoring<br>System is intended to measure glucose in<br>whole capillary blood by persons with diabetes<br>or by health care professionals in the home or<br>in health care facilities. | |
| Comparison to Predicate: | The microdot® Blood Glucose Monitoring<br>System is substantially equivalent to the<br>LifeScan One Touch Ultra blood glucose<br>testing system. | |
| Non-Clinical performance: | Linearity studies with venous blood spiked with<br>glucose from 20 to 520 mg/dL gave a slope of<br>0.93 and 0.94 respectively with 2 lots of strips<br>and a correlation coefficient of 0.996. | |
| | Within run precision of 20 readings with<br>glucose spiked venous blood carried out in one<br>day gave cv's of 5.48 % at 43 mg/dL, 4.01% at<br>81 mg/dL, 3.31% at 124 mg/dl and 2.91% at<br>197 mg/dL and 2.9% at 296 mg/dL. | |
| | Effect of hematocrit over the range of 30 to<br>50% was tested at nominal glucose<br>concentrations of 60, 150, 250 and 400 mg/dL.<br>There is a positive bias at low hematocrit and a<br>negative bias at high hematocrit. The results<br>shown that in the range 30- 50%, the bias<br>criteria of ≤± 15 mg/dL for samples below 75<br>mg/dL and ≤±20% for samples above 75 mg/dL<br>is met. | |
| Clinical Study: | In a clinical study carried out with 121 diabetic<br>patients, the regression equation for microdot®<br>against the YSI reference method was<br>y=1.0055x + 0.7776, r = 0.982 when the tests<br>were carried out by healthcare professionals.<br>Te same patient samples tested on the One<br>Touch® Ultra™ by healthcare professionals<br>gave a linear regression equation of y =<br>0.9705 - 1.3727, r = 0.988. | |
| Conclusion: | The microdot® Blood Glucose Test System is<br>substantially equivalent to the LifeScan One<br>Touch Ultra blood glucose monitor. | |

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Image /page/2/Picture/1 description: The image shows a circular seal with an eagle in the center. The eagle is stylized with three lines forming its body and head. The text around the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Cambridge Sensor Limited c/o Mr. Warren Reeves Units 9 and 10, Cardinal Park Godmanchester, Huntingdon Cambridgeshire PE29 2XG United Kingdom

Re: k070524

Trade Name: Microdot Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: 75, NBW, LFR, JJX Dated: May 24, 2007 Received: May 31, 2007

Dear Mr. Reeves:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JUN 2 2 2007

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

### 510(k) Number (if known):_k070524

## Device Name: Microdot Blood Glucose Monitoring System: blood glucose monitor

#### Indications For Use:

microdot Blood Glucose Monitoring System

microdot Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.

### microdot Blood Glucose Meter

The microdot Blood Glucose Meter is intended for the quantitative measurement r fromlers 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. It is intended for monitoring of blood glucose levels only.

#### microdot Test Strips

The microdot Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by o grassowith diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.

#### microdot Control solutions

miorodot oontrol solutions are intended for use with microdot Blood Glucose Meter and microdot Test Strips as a quality control check to verify the accuracy of the blood glucose test results.

Over-The-Counter Use X AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Sa

Evaluation
510(k) k070524

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