The GLUCOMETER ELITE® Test Strips are used with the GLUCOMETER ELITE® XL Blood Glucose Meter and the GLUCOMETER ELITE® Blood Glucose Test Systems to measure the glucose level in whole blood. The GLUCOMETER ELITE® XL and GLUCOMETER ELITE® Blood Glucose Systems are home-use (OTC) devices used by persons with diabetes, and by healthcare professionals in clinical settings for the self-monitoring of blood glucose and as an adjunct to the care of persons with diabetes.

Device Description

The GLUCOMETER ELITE® Test Strips (Modified) are for use with the GLUCOMETER ELITE® family of blood glucose meters. The GLUCOMETER ELITE® Blood Glucose Test System is an over-the-counter (OTC) home test for glucose in blood. The system is used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GLUCOMETER ELITE® Test Strips.

Based on the document, the device is not an AI/ML device, therefore, many of the typical acceptance criteria and study design elements found in AI/ML device approval are not applicable. The device is a blood glucose test strip, a traditional in-vitro diagnostic.

However, I will extract the relevant information concerning performance and testing for this type of device.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance
Suitable for intended use with 2 µL blood sample (primary change from predicate)	"The studies indicate that the GLUCOMETER ELITE® Test Strips with the reduced volume are suitable for their intended use." and "The results of the evaluation of the GLUCOMETER ELITE® Test Strips (Modified) demonstrate satisfactory performance with 2 uL of specimen and are suitable for their intended use."
Specificity for glucose	"The GLUCOMETER ELITE® Blood Glucose Test Systems are specific for glucose..."
Plasma/serum equivalent glucose results	"...and have been referenced to give plasma/serum equivalent glucose results."
Quantitative measurement of glucose in whole blood range	"These test systems provide a quantitative measurement of glucose in whole blood from 20 - 600 mg/dL (1.1 to 33.3 mmol/L)."

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

Sample Size for Test Set: Not explicitly stated. The document mentions "An in-house evaluation of the performance..." and "The studies indicate...", but no specific number of samples or subjects is provided for the test set.
Data Provenance: The study was "in-house," suggesting it was conducted by the manufacturer, Bayer Corporation. The country of origin of the data is not specified, but the manufacturer is listed as based in Elkhart, IN, USA, and the strips are manufactured in Kyoto, Japan. Given the "in-house" nature, it's likely a prospective evaluation specifically designed to test the modified strips.

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

Not Applicable. This device is an in-vitro diagnostic for measuring a biochemical marker (glucose), not an imaging or diagnostic AI/ML system requiring expert interpretation for ground truth. Ground truth for blood glucose measurements is established through a reference laboratory method.

4. Adjudication method for the test set

Not Applicable. As noted above, this is not an AI/ML device requiring expert adjudication. Performance here refers to the device's accuracy and precision against a reference method.

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 is not an AI/ML device, and there are no "human readers" in the context of interpreting results from this test strip. Its purpose is to provide a quantitative measurement of glucose.

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

Partially Applicable / Standalone (Device Only): The performance assessment was on the "GLUCOMETER ELITE® Test Strips (Modified)," which essentially is the standalone performance of the test strip and meter system. There is no human interpretation component in producing the numerical glucose reading. The study evaluates the device's ability to accurately measure glucose without human intervention influencing the measurement itself.

7. The type of ground truth used

Reference Method: While not explicitly stated in the provided text, for blood glucose measurement devices, ground truth is typically established using a highly accurate and precise laboratory reference method (e.g., hexokinase method) on the same blood samples. The document states the system "have been referenced to give plasma/serum equivalent glucose results," implying comparison to such a reference.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a "training set." The strips are based on a chemical reaction (Glucose Oxidase method) and electrical potential measurement, not a learned algorithm.

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

Not Applicable. As there is no training set for this type of device, this question is not relevant.

Summary

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JUN 30 1999

K991242

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510(k) SAFETY AND EFFECTIVENESS SUMMARY

Prepared:	April 9, 1999
Submitter:	Bayer Corporation, Business Group Diagnostics
Address:	1884 Miles Avenue, P.O. Box 70Elkhart, IN 46515(219) 262-6928
Contact:	George M. Tancos R.A.C.Manager, Regulatory Compliance
Device:	Trade/Proprietary Name:Common/Usual Name:Document Control Number:	GLUCOMETER ELITE® Test StripsTest for glucose in bloodK991242
Classification Name:	The GLUCOMETER ELITE® Test Strips and the GLUCOMETERELITE® family of blood glucose meters are used to test for glucose inblood. In 21 CFR 862.1345, a glucose test system is classified as aClass II medical device.
Predicate Device:	GLUCOMETER ELITE® Test Strips
Manufactured by:	The GLUCOMETER ELITE® Test Strips are produced by ArkrayKDK Corporation of Kyoto, Japan.
Device Description:	The GLUCOMETER ELITE® Test Strips (Modified) are for use withthe GLUCOMETER ELITE® family of blood glucose meters. TheGLUCOMETER ELITE® Blood Glucose Test System is an over-the-counter (OTC) home test for glucose in blood. The system is used bypersons with diabetes and by healthcare professionals in home settingsand in healthcare facilities.
Intended Use:	The GLUCOMETER ELITE® Blood Glucose Test Systems are usedfor self-monitoring of blood glucose as an adjunct to the care of personswith diabetes.

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Technological Characteristics:

The GLUCOMETER ELITE® Blood Glucose Test Systems are specific for glucose and have been referenced to give plasma/serum equivalent glucose results. These test systems provide a quantitative measurement of glucose in whole blood from 20 - 600 mg/dL (1.1 to 33.3 mmol/L).

The GLUCOMETER ELITE® Test Strips are based on the measurement of electrical potential caused by the reaction of glucose with the reagents (Glucose Oxidase method) on the electrode of the strip.

Assessment of Performance:

An in-house evaluation of the performance of the GLUCOMETER ELITE® Test Strips (Modified) was conducted to demonstrate and verify the performance with a 2 uL blood sample. The studies indicate that the GLUCOMETER ELITE® Test Strips with the reduced volume are suitable for their intended use.

Conclusion:

The results of the evaluation of the GLUCOMETER ELITE® Test Strips (Modified) demonstrate satisfactory performance with 2 uL of specimen and are suitable for their intended use.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and health.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 30 1999

Mr. George M. Tancos, R.A.C. Manager, Regulatory Compliance Bayer Corporation Business Group Diagnostics 1884 Miles Avenue P.O. Box 70 Elkhart, Indiana 46515-0070

Re: K991242

Trade Name: GLUCOMETER ELITE® Test Strips (Modified) Regulatory Class: II Product Code: CGA Dated: April 9, 1999 Received: April 12, 1999

Dear Mr. Tancos:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 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, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/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

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510(k) Number (if known): K99 (2 4)

GLUCOMETER ELITE® Test Strips Device Name:

Indications for Use: The GLUCOMETER ELITE® Test Strips are used with the GLUCOMETER ELITE® XL Blood Glucose Meter and the GLUCOMETER ELITE® Blood Glucose Test Systems to measure the glucose level in whole blood. The GLUCOMETER ELITE® XL and GLUCOMETER ELITE® Blood Glucose Systems are home-use (OTC) devices used by persons with diabetes, and by healthcare professionals in clinical settings for the self-monitoring of blood glucose and as an adjunct to the care of persons with diabetes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson for Jean Cooper

(Division Sign Off)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991242

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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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.