GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) by BAYER GROUP DIAGNOSTICS

The GLUCOMETER ELITE® and the GLUCOMETER ELITE® XL Blood Glucose Meters are used with GLUCOMETER ELITE® Test Strips to measure glucose levels in whole blood from specimens taken from the fingers or an alternate puncture site within certain conditions. The GLUCOMETER ELITE Diabetes Care System is an overthe-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Device Description

The GLUCOMETER ELITE® Diabetes Care System includes the GLUCOMETER ELITE®, GLUCOMETER ELITE® XL Blood Glucose Meters and the GLUCOMETER ELITE® Test Strips. The system is an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing blood glucose by persons with diabetes in the home or by healthcare professionals in healthcare facilities.

AI/ML Overview

The provided text describes the GLUCOMETER ELITE® Diabetes Care System. However, it does not contain specific acceptance criteria (like accuracy percentages or specific ranges) or detailed study outcomes that would fit into a table format as requested. The document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical trial report with specific performance metrics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance with specific numerical values for metrics like accuracy, sensitivity, or specificity.

I can, however, extract the information that is present:

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Intended Use	The studies demonstrate that users can obtain blood glucose results from alternate puncture sites that are substantially equivalent to blood glucose results obtained from fingersticks within certain conditions explained in product labeling.
Linearity	The System has a linear response to glucose from 20-600 mg/dL.
Equivalence	The clinical evaluation demonstrates that the device can produce blood glucose results from alternate puncture sites that are equivalent to blood glucose results obtained from fingersticks within certain conditions explained in product labeling.

Here's what can be extracted regarding the study and ground truth, along with limitations due to the nature of the provided document:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The study was conducted "in a clinical setting by persons with diabetes." No country of origin is explicitly mentioned, but the submitter is Bayer Diagnostics in Elkhart, IN, USA, and the FDA approval is for the US market. It's not explicitly stated if it was retrospective or prospective, but clinical studies for device approval are typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Adjudication method for the test set:
- Not specified.
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, an MRMC comparative effectiveness study was not done. This device is a blood glucose meter, not an AI-powered diagnostic imaging tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The study assessed the device's ability to produce blood glucose results from alternate puncture sites, compared to fingersticks. This is a "standalone" performance assessment in the sense that it's evaluating the device's measurement capability directly, not its interaction with an interpreting human, beyond the user operating the device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for comparison was blood glucose results obtained from fingersticks. This implies that fingerstick measurements (likely taken with a reference method or a predicate device) were considered the standard against which alternate puncture site measurements were compared.
The sample size for the training set:
- Not specified. This document describes a clinical performance assessment, not the development and training of a machine learning model. Therefore, the concept of a "training set" in the AI sense does not apply here.
How the ground truth for the training set was established:
- Not applicable, as no AI training set is mentioned.

Summary

{0}------------------------------------------------

APR 2 9 2002

Bayer Diagnostics GLUCOMETER ELITE® Diabetes Care System S&E Summary Page 1 of 2

510(k) SAFETY AND EFFECTIVENESS SUMMARY

January 18, 2002 Prepared: Bayer Diagnostics Submitter: 1884 Miles Avenue, P.O. Box 70 Address: Elkhart, IN 46515 (219) 262-6928 George M. Tancos, RAC Contact: Manager, Regulatory Compliance Trade/Proprietary Name: GLUCOMETER ELITE® Diabetes Care Device: System Blood Glucose Meter Common/Usual Name: Blood Glucose Test Strips Document Control Number: K020208 Division of Clinical Laboratory Devices Classification: Panel - Clinical Chemistry and Toxicology Classification Code - 75CGA (Glucose Oxidase, Glucose) GLUCOMETER ELITE® Blood Glucose Meter Predicate Devices: GLUCOMETER ELITE® XL Blood Glucose Meter GLUCOMTER ELITE® Test Strips

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

The GLUCOMETER ELITE® Diabetes Care System includes the Device Description: GLUCOMETER ELITE®, GLUCOMETER ELITE® XL Blood Glucose Meters and the GLUCOMETER ELITE® Test Strips. The system is an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing blood glucose by persons with diabetes in the home or by healthcare professionals in healthcare facilities. The GLUCOMETER ELITE® Diabetes Care System is intended Intended Use: for the Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.4 Technological The GLUCOMETER ELITE® Diabetes Care System employs an Characteristics: amperometric glucose oxidase method to measure glucose in blood. It is conceptually the same as other blood glucose monitoring products available for blood glucose testing. Blood glucose results are referenced to plasma glucose. The System has a linear response to glucose from 20-600 mg/dL. Assessment of The GLUCOMETER ELITE® Diabetes Care System was studied Performance: in a clinical setting by persons with diabetes. The studies demonstrate that users can obtain blood glucose results from alternate puncture sites that are substantially equivalent to blood glucose results obtained from fingersticks within certain conditions explained in product labeling. The results of the clinical evaluation of the GLUCOMETER Conclusion: ELITE® Diabetes Care System demonstrate that the device can produce blood glucose results from alternate puncture sites that are equivalent to blood glucose results obtained from fingersticks within certain conditions explained in product labeling.

1 "Consensus Statement on Self-Monitoring of Blood Glucose, " Diabetes Care, Vol. 10, No. 1, January-February 1987, pp. 95.99

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 9 2002

Mr. George M. Tancos Manager, Regulatory Compliance Bayer Corporation 1884 Miles Avenue P.O. Box 70 Elkhart, IN 46515-0070

Re: K020208

Trade/Device Name: GLUCOMETER ELITE® Diabetes Care System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 28, 2002 Received: March 29, 2002

Dear Mr. Tancos:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encreative) it its 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 I ou may , aron's 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 11 your device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 or uny 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and it your ding of substantial equivalence of your device to a legally marketed noutication. THE I DIT in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-4539. In and Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on 7001 165port 105port Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K020208

Device Name:

GLUCOMETER ELITE ® Diabetes Care System

Indications for Use:

Jean Cooge

sion Sign-Off)
ion of Clinical Laboratory Devices
5.0(k) Number K020208

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

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.