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.

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 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 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.

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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the microdot® Xtra Blood Glucose Monitoring System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information typically found in a full submission that would include acceptance criteria, specific performance data from studies, ground truth establishment, sample sizes for test and training sets, or expert involvement.

Therefore, I can only provide information based on what is present in the document and explicitly state what is missing.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state specific acceptance criteria (e.g., specific accuracy ranges, precision limits, or clinical metrics) for the device's performance. The submission asserts "substantial equivalence" to a predicate device, implying that its performance should be comparable, but no quantitative targets are given in this summary.
Reported Device Performance: The document does not include any reported quantitative device performance data from a study. It only states that the device is "substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system."

Acceptance Criteria	Reported Device Performance
Not stated (No specific quantitative acceptance criteria are provided in the 510(k) summary.)	Not stated (No quantitative performance data or study results are reported in the 510(k) summary.)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in this 510(k) summary.
Data Provenance: Not specified in this 510(k) summary. The document mentions the applicant is "Cambridge Sensors Limited" in the "United Kingdom," but does not explicitly state the origin of any test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. For blood glucose meters, "ground truth" is typically established by laboratory reference methods, not by expert consensus on images.

4. Adjudication method for the test set

This information is not provided in the 510(k) summary. Given the nature of a blood glucose meter, expert adjudication as seen in image analysis is generally not applicable. Ground truth for blood glucose is usually determined by established laboratory reference methods.

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

A MRMC comparative effectiveness study is not applicable and was not done for this device. This device is a standalone blood glucose meter, not an AI-assisted diagnostic tool that interprets medical images for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device operates as a standalone system. The microdot® Xtra Blood Glucose Monitoring System is an electrochemical biosensor designed to measure glucose directly from fresh capillary whole blood. Its output (glucose concentration) is a direct result of the chemical reaction and electronic measurement without human interpretation or algorithm assistance during the measurement process itself. The user applies the blood and the meter displays the result.

7. The type of ground truth used

The document implies that the ground truth for glucose measurements would be established using a laboratory reference method (such as a YSI glucose analyzer, which is common for blood glucose meter validation). The device is calibrated to "Plasma equivalent" values, which are derived from such reference methods. However, the specific reference method used is not explicitly stated in this summary.

8. The sample size for the training set

Not applicable / Not specified. Blood glucose meters typically do not have a "training set" in the sense that AI algorithms do. Their performance is based on the inherent physical and chemical properties of the electrochemical biosensor and its calibration. While there's internal calibration data used by the manufacturer, it's not a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable / Not specified. As mentioned above, the concept of a "training set" and its associated ground truth establishment methods (like expert consensus, pathology, etc.) does not directly apply to the development and validation of a traditional electrochemical blood glucose meter described in this document. The device's calibration refers to ensuring its readings align with established laboratory reference methods for glucose.

Summary

{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)
1. 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)

1. Panel: Clinical chemistry (75)

{1}------------------------------------------------

5.7 Intended Use

Intended use(s):

microdof® Xtra Blood Glucose Monitoring System

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:

{2}------------------------------------------------

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®(K070524)
Characteristic/aspect	Auto Code System	Code enteredaccording to newvalue on strip vial
Intended Use	Blood glucosemonitoring for homeand point of care	Same
Sample	Fresh Capillarywhole blood	Same
Test Principle	ElectrochemicalBiosensor	Same
Calibration	Plasma equivalent	Same
Sample volume	600nanoliters	Same
Temperature andhumidity range	10°- 40°C10-90% RH	Same
Control Solutions	3 levels	Same
Color	Blue	Same
Fill Volume	4 ml	Same
Matrix	Buffered aqueoussolution of D-glucose, viscositymodifier,preservatives andother, non-reactiveingredients	Same
Stability	Strips and controls,3 months afteropening	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,

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

Regulation Number and Section

§ 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.