(119 days)
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.
The microdot® Blood Glucose System is comprised of the microdot® Meter, Test Strips, & three controls. The test strip is inserted into the device, a drop of blood is added to the strip, and a glucose result is presented in 10 seconds.
The test principle is based on electrochemical biosensor technology. Glucose dehydrogenase converts to glucose to gluconolactone, with reduction of NAD to NADH. Re-oxidation of the mediator by the meter induces a micro current to flow, and the size of the micro current is directly proportional to the amount of glucose in the blood. The micro current is detected in of the blood glucose concentration.
The provided document describes the microdot® Blood Glucose Monitoring System and its performance studies. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for accuracy in the same way modern regulatory submissions do (e.g., ISO 15197:2013). However, it reports on several performance metrics that demonstrate its equivalence to a predicate device and its overall functionality. Given the context of the comparison to the predicate device and the non-clinical and clinical study results, the implied acceptance criterion for accuracy is a strong correlation with a reference method and acceptable bias within a specified hematocrit range.
| Performance Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Accuracy (Clinical Study) | Strong correlation with YSI reference method and similar performance to predicate device. | Regression equation for microdot® vs. YSI: y = 1.0055x + 0.7776, r = 0.982 (when tests carried out by healthcare professionals).Predicate (One Touch® Ultra™) vs. YSI: y = 0.9705x - 1.3727, r = 0.988. |
| Linearity | High correlation coefficient (r > 0.99) across the measuring range. | Venous blood spiked with glucose (20 to 520 mg/dL):- Lot 1: slope = 0.93, r = 0.996- Lot 2: slope = 0.94, r = 0.996 |
| Precision (Within-run CV%) | Low coefficient of variation (CV%) at various glucose concentrations. Specific criteria not defined, but generally <5% at higher concentrations and acceptable at lower concentrations to demonstrate reliability. | 20 readings with glucose spiked venous blood (one day study):- 5.48 % at 43 mg/dL- 4.01% at 81 mg/dL- 3.31% at 124 mg/dl- 2.91% at 197 mg/dL- 2.9% at 296 mg/dL |
| Hematocrit Effects (Bias) | ≤± 15 mg/dL for samples below 75 mg/dL and ≤±20% for samples above 75 mg/dL. | Tested over 30% to 50% hematocrit range at nominal glucose concentrations of 60, 150, 250, and 400 mg/dL.The results shown that in the range 30-50%, the bias criteria of ≤± 15 mg/dL for samples below 75 mg/dL and ≤±20% for samples above 75 mg/dL is met. (There is a positive bias at low hematocrit and a negative bias at high hematocrit, but still within criteria). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions 121 diabetic patients for the clinical study.
The provenance of the data is not explicitly stated in terms of country of origin. The study is described as a "clinical study," implying a prospective design, but it's not explicitly labeled as prospective or retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set in the clinical study was established using the YSI reference method. This is an automated laboratory analyzer for measuring glucose and does not involve human experts in establishing the ground truth directly for each measurement. The measurements were "carried out by healthcare professionals," but their role was in performing the glucose tests, not in establishing the ground truth itself.
4. Adjudication Method for the Test Set
Not applicable. Ground truth was established by an automated reference method (YSI), not through expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or analysis tool that typically involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (linearity, precision, hematocrit effects, and the YSI comparison in the clinical study) represents the standalone performance of the microdot® Blood Glucose Monitoring System. While "healthcare professionals" performed the tests in the clinical study, they were operating the device as intended, not providing an interpretation that the algorithm then validated or assisted with. The system itself provides the glucose reading.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used was a reference laboratory method, specifically the YSI reference method, which is a highly accurate and standardized method for glucose measurement.
8. The Sample Size for the Training Set
The document refers to performance studies and a clinical study, but does not explicitly mention a "training set" or "validation set" in the context of machine learning. Blood glucose meters are typically calibrated during manufacturing, and their performance is then validated through studies like those described. The data from the linearity, precision, and hematocrit studies contribute to understanding the device's inherent performance.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the machine learning sense is explicitly described, this question is not fully applicable. However, the ground truth for establishing the device's fundamental performance characteristics (like linearity and precision) would have been based on controlled samples with known glucose concentrations, likely verified by reference laboratory methods.
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Summary for Public Disclosure
| Applicant: | Cambridge Sensors Ltd.Units 9 and 10,Cardinal Park,Godmanchester, Huntingdon,Cambridgeshire, PE29 2XGUnited 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 iscomprised of the microdot® Meter, Test Strips,& three controls. The test strip is inserted intothe device, a drop of blood is added to the strip,and a glucose result is presented in 10seconds.The test principle is based on electrochemicalbiosensor technology. Glucose dehydrogenaseconverts to glucose to gluconolactone, withreduction of NAD to NADH. Re-oxidation of themediator by the meter induces a micro currentto flow, and the size of the micro current isdirectly proportional to the amount of glucosein the blood. The micro current is detected in ofthe blood glucose concentration. | |
| Intended use: | The microdot® Blood Glucose MonitoringSystem is intended to measure glucose inwhole capillary blood by persons with diabetesor by health care professionals in the home orin health care facilities. | |
| Comparison to Predicate: | The microdot® Blood Glucose MonitoringSystem is substantially equivalent to theLifeScan One Touch Ultra blood glucosetesting system. | |
| Non-Clinical performance: | Linearity studies with venous blood spiked withglucose from 20 to 520 mg/dL gave a slope of0.93 and 0.94 respectively with 2 lots of stripsand a correlation coefficient of 0.996. | |
| Within run precision of 20 readings withglucose spiked venous blood carried out in oneday gave cv's of 5.48 % at 43 mg/dL, 4.01% at81 mg/dL, 3.31% at 124 mg/dl and 2.91% at197 mg/dL and 2.9% at 296 mg/dL. | ||
| Effect of hematocrit over the range of 30 to50% was tested at nominal glucoseconcentrations of 60, 150, 250 and 400 mg/dL.There is a positive bias at low hematocrit and anegative bias at high hematocrit. The resultsshown that in the range 30- 50%, the biascriteria of ≤± 15 mg/dL for samples below 75mg/dL and ≤±20% for samples above 75 mg/dLis met. | ||
| Clinical Study: | In a clinical study carried out with 121 diabeticpatients, the regression equation for microdot®against the YSI reference method wasy=1.0055x + 0.7776, r = 0.982 when the testswere carried out by healthcare professionals.Te same patient samples tested on the OneTouch® Ultra™ by healthcare professionalsgave a linear regression equation of y =0.9705 - 1.3727, r = 0.988. | |
| Conclusion: | The microdot® Blood Glucose Test System issubstantially equivalent to the LifeScan OneTouch 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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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
Page 1 of
§ 862.1345 Glucose test system.
(a)
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.(b)
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.