(119 days)
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No
The description focuses on electrochemical biosensor technology and does not mention any AI or ML components.
No.
The device is intended for monitoring blood glucose levels, not for treating a condition, disease, or injury.
Yes
The device is intended for the quantitative measurement of glucose in capillary whole blood, which is used for monitoring blood glucose levels. This measurement provides information for determining a medical condition (diabetes) and is used for diagnosis or to help manage the disease.
No
The device description explicitly states it is comprised of a meter, test strips, and controls, which are all hardware components. The test principle is based on electrochemical biosensor technology, which is also a hardware-based method.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "self testing of glucose in capillary whole blood" and "monitoring of blood glucose levels." This involves testing a biological sample (blood) outside of the body to gain information about a person's health status.
- Device Description: The description details how the device works by analyzing a "drop of blood" added to a "test strip" to measure glucose concentration. This is a classic description of an in vitro diagnostic process.
- Anatomical Site: The sample is taken from "capillary whole blood from a fingerstick," which is a biological sample collected from the body for analysis.
- Test Principle: The electrochemical biosensor technology described involves a chemical reaction with the blood sample to produce a measurable signal related to glucose concentration. This is an in vitro process.
- Control Solutions: The use of control solutions to "verify the accuracy of the blood glucose test results" is a standard practice for ensuring the reliability of IVD devices.
All these elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for 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.
Product codes
75, NBW, LFR, JJX
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
persons with diabetes or by health care professionals in the home or in health care facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Non-Clinical performance: Linearity studies with venous blood spiked with glucose from 20 to 520 mg/dL gave a slope of 0.93 and 0.94 respectively with 2 lots of strips and a correlation coefficient of 0.996.
Within run precision of 20 readings with glucose spiked venous blood carried out in one day gave cv's of 5.48 % at 43 mg/dL, 4.01% at 81 mg/dL, 3.31% at 124 mg/dl and 2.91% at 197 mg/dL and 2.9% at 296 mg/dL.
Effect of hematocrit over the range of 30 to 50% was tested at nominal glucose concentrations of 60, 150, 250 and 400 mg/dL. There is a positive bias at low hematocrit and a negative bias at high hematocrit. 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.
Clinical Study: In a clinical study carried out with 121 diabetic patients, the regression equation for microdot® against the YSI reference method was y=1.0055x + 0.7776, r = 0.982 when the tests were carried out by healthcare professionals. Te same patient samples tested on the One Touch® Ultra™ by healthcare professionals gave a linear regression equation of y = 0.9705 - 1.3727, r = 0.988.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Summary for Public Disclosure
| Applicant: | Cambridge Sensors Ltd.
Units 9 and 10,
Cardinal Park,
Godmanchester, Huntingdon,
Cambridgeshire, PE29 2XG
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
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. | |
| 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. | |
| Comparison to Predicate: | The microdot® Blood Glucose Monitoring
System is substantially equivalent to the
LifeScan One Touch Ultra blood glucose
testing system. | |
| Non-Clinical performance: | Linearity studies with venous blood spiked with
glucose from 20 to 520 mg/dL gave a slope of
0.93 and 0.94 respectively with 2 lots of strips
and a correlation coefficient of 0.996. | |
| | Within run precision of 20 readings with
glucose spiked venous blood carried out in one
day gave cv's of 5.48 % at 43 mg/dL, 4.01% at
81 mg/dL, 3.31% at 124 mg/dl and 2.91% at
197 mg/dL and 2.9% at 296 mg/dL. | |
| | Effect of hematocrit over the range of 30 to
50% was tested at nominal glucose
concentrations of 60, 150, 250 and 400 mg/dL.
There is a positive bias at low hematocrit and a
negative bias at high hematocrit. 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. | |
| Clinical Study: | In a clinical study carried out with 121 diabetic
patients, the regression equation for microdot®
against the YSI reference method was
y=1.0055x + 0.7776, r = 0.982 when the tests
were carried out by healthcare professionals.
Te same patient samples tested on the One
Touch® Ultra™ by healthcare professionals
gave a linear regression equation of y =
0.9705 - 1.3727, r = 0.988. | |
| Conclusion: | The microdot® Blood Glucose Test System is
substantially equivalent to the LifeScan One
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 (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
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