The Advance Micro-draw™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Advance Micro-draw™ Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Advance Micro-draw™ Test Strips must be used with the Advance Microdraw™ Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

For use with Advance Micro-draw™ Blood Glucose Meter and Advance Microdraw™ Test Strips as a quality control check to verify the accuracy of blood qlucose test results.

Device Description

The Advance Micro-draw™ Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Advance Micro-draw™ Blood Glucose Test Strips.

AI/ML Overview

The provided document is a 510(k) summary for the Advance Micro-draw™ Blood Glucose Monitoring System, seeking clearance for an expanded indication to include palm testing in addition to fingertip testing. It does not provide detailed acceptance criteria or a comprehensive study report with the level of detail requested for an AI/device performance study.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy percentages, bias limits) that the device must meet. It only states that "Linear regression statistics showed good correlation between fingertip and alternate site results."

Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (from "7. CLINICAL TESTING")
Not provided in the document	Linear regression statistics showed good correlation between fingertip and alternate site (palm) results.
	Tested blood glucose values encompassed the 51-435 mg/dL glucose range.

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

Test Set Sample Size: "Testing included both men and women, both Type 1 and Type 2 diabetes, ages from twenty to seventy-eight." A specific number of participants or samples is not provided.
Data Provenance: The document does not specify the country of origin of the data. It implies a prospective study as it describes "testing was done comparing fingertip results obtained by clinicians with alternate site results obtained by participants with diabetes."

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

The "ground truth" in this context would likely be the fingertip blood glucose measurement, which is considered the standard for comparison.

Number of experts: The document mentions "clinicians" obtained fingertip results, but does not specify the number or qualifications of these clinicians.
Qualifications of experts: Not provided.

4. Adjudication method for the test set

There is no information on any adjudication method. For a blood glucose meter, the "ground truth" or reference method is typically another validated glucose measurement method (e.g., a laboratory analyzer), and the device's readings are compared directly to that. Differences are usually handled statistically without a need for expert adjudication in the same way an imaging study might.

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

No, this is not applicable. The device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation device that human readers would use. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

Yes, this was effectively a standalone performance study. The Advance Micro-draw™ Blood Glucose Monitoring System is a device that provides a direct numerical output. The study compared the device's readings from the palm (new indication) against its readings from the fingertip (established method), both of which are "algorithm-only" outputs from the device itself. The primary objective was to show the equivalence of the device's performance at the alternate site.

7. The type of ground truth used

The "ground truth" or reference method for the alternate site (palm) measurements was the fingertip blood glucose results obtained by clinicians. While not explicitly stated, clinical practice for blood glucose meter validation typically involves comparison to a highly accurate laboratory reference method (e.g., hexokinase or glucose oxidase methods) for the initial validation of the fingertip readings, and then the fingertip reading can serve as the "clinical ground truth" for comparing alternate sites. The document implies the fingertip results were the standard against which the palm results were compared.

8. The sample size for the training set

This document describes a clinical validation study for an expanded indication. It does not provide information about a "training set" as it would for a machine learning model. Blood glucose meters are typically developed and calibrated in a different manner, involving engineering and chemistry, rather than machine learning training sets in the AI sense.

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

As a training set is not explicitly mentioned or relevant to the traditional development of a blood glucose meter, no information is provided on how its "ground truth" was established.

Summary

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Ko4/881/

MAR 2 5 2005

510(k) Summary

1. SUBMITTED BY:	Bruce A. MacFarlane, Ph.D.Hypoguard USA, Inc.5182 West 76 th StreetMinneapolis, MN 55439USA
	Summary prepared: 28 February 2005
2. NAME OF DEVICES:
Trade Names:	Advance Micro-draw TM Glucose Monitoring SystemAdvance Micro-draw TM Test StripsAdvance Micro-draw TM High Control SolutionAdvance Micro-draw TM Normal Control Solution
Common Names/Descriptions:	Blood glucose monitoring system
Classification Names:	- Glucose test system, product codes CGA & NBW,21 CFR 862.1345- Single (specified) analyte controls(assayed/unassayed), product code JJX, 21CFR 862.1660
Regulatory Status:	Class II
PREDICATE DEVICE:	LifeScan OneTouch ® Ultra ® Blood GlucoseMonitoring System 1

DEVICE DESCRIPTION:

1 OneTouch and Ultra are registered trademarks of LifeScan, Inc.

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510(k) Summary (cont'd)

Hypoguard USA, Inc.

4. INTENDED USE:

5. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The Advance Micro-draw™ Blood Glucose Monitoring System is technically unchanged by this expansion of indications (claiming palm in addition to fingertip testing). The Advance Micro-draw™ trade name was "Hypoguard Advance™" at the time of initial premarket notification.

6. NON-CLINICAL TESTING

Not Applicable

7. CLINICAL TESTING

Accuracy/method correlation testing was done comparing fingertip results obtained by clinicians with alternate site results obtained by participants with diabetes.

Testing included both men and women, both Type 1 and Type 2 diabetes, ages from twenty to seventy-eight. Tested blood glucose values encompassed the 51-435 mg/dL glucose range. Linear regression statistics showed good correlation between fingertip and alternate site results.

8. CONCLUSIONS FROM TESTING

Testing demonstrated that the performance of Advance Micro-draw™ at the claimed alternate site was substantially equivalent to that at fingertip.

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Image /page/2/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 a human figure in profile, with three overlapping shapes representing the head, body, and legs.

MAR 2 5 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bruce A. MacFarlanc, Ph.D. Vice President, Regulatory Affairs and Quality Systems Hypoguard USA, Inc. 5182 West 76" Street Minneapolis, MN 55439

Re: k()41881

Trade/Device Name: Advance Micro-draw™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW. CGA, JJX Dated: February 28, 2005 Received: March 1, 2005

Dear Dr. MacFarlane:

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

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Page 2 -

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)276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper MS, DUM

Jean M. Cooper, MS, 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): K041881

Device Name: Advance Micro-draw™ Blood Glucose Monitoring System

Indications For Use:

Advance Micro-draw™ Blood Glucose Monitoring System:

The Advance Micro-draw™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Advance Micro-draw™ Blood Glucose Test Strips:

Advance Micro-draw™ Control Solution:

For use with Advance Micro-draw™ Blood Glucose Meter and Advance Microdraw™ Test Strips as a quality control check to verify the accuracy of blood qlucose test results.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use V (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Carol C. Benson

37 K041881

Page 1 of 1

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.