The GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter (OTC) home testing systems for glucose in blood. These systems are for use by person with diabetes and by healthcare professionals in a home setting and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Device Description

GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter home tests for glucose in blood. They are for use by persons with diabetes and by healthcare professional in home settings and in healthcare facilities. The GLUCOMETER ELITE Blood Glucose Test Strips are for use with the GLUCOMETER ELITE Blood Glucose Test family of meters.

The GLUCOMETER ELITE and the GLUCOMETER ELITE XL Blood Glucose Meters are specific for glucose and have been referenced to give plasmalserum equivalent glucose results. The test systems provide a quantitative measurement of glucose in whole blood from 10 - 600 mg/dL (0.6 to 33.3 mmol/L). In addition, both the GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER XL Blood Glucose Meter can be used with arterial blood specimens. The GLUCOMETER XL Blood Glucose Meter can be used with neonatal specimens.

The GLUCOMETER ELITE Blood Glucose 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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Glucometer® Elite® Blood Glucose Test Systems:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria (e.g., "accuracy should be within +/- X% of reference method Y"). Instead, it focuses on demonstrating suitability for expanded use cases.

Acceptance Criteria (Implied)	Reported Device Performance
Suitable for intended use with neonatal specimens (GLUCOMETER ELITE XL)	"The results of the evaluation of the GLUCOMETER ELITE XL Blood Glucose Meter demonstrate the expanded use for neonatal... specimens" (Section 1)
Suitable for intended use with arterial specimens (GLUCOMETER ELITE XL)	"The results of the evaluation of the GLUCOMETER ELITE XL Blood Glucose Meter demonstrate the expanded use for... arterial specimens" (Section 1)
Suitable for intended use with arterial specimens (GLUCOMETER ELITE)	"a separate clinical study was conducted to likewise demonstrate the efficacy of the GLUCOMETER ELITE Blood Glucose Test Systems for use with arterial samples." and "the GLUCOMETER ELITE Blood Glucose Test Systems use of arterial specimens are suitable for its intended use." (Section 1)
Quantitative measurement of glucose in whole blood	"The test systems provide a quantitative measurement of glucose in whole blood from 10 - 600 mg/dL (0.6 to 33.3 mmol/L)." (Section 1)

2. Sample Size Used for the Test Set and Data Provenance

The text states that evaluations were "conducted at four clinical sites" and a "separate clinical study was conducted." However, it does not provide specific sample sizes for the test set(s) or the country of origin of the data. Given the "Conclusion" statement and the nature of medical device submissions, it is highly likely that these were prospective studies since they were conducted to demonstrate performance for expanded indications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth. For a blood glucose meter, ground truth is typically established using a highly accurate laboratory reference method, not necessarily by expert consensus in a subjective sense.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set. This is not typically relevant for quantitative measurements like blood glucose, where a reference laboratory method provides the "truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is primarily relevant for imaging diagnostics where human interpretation is a key component, often assisted by AI. The Glucometer® is a direct measurement device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation was conducted. The studies described evaluating the "GLUCOMETER ELITE XL Blood Glucose Meter" and the "GLUCOMETER ELITE Blood Glucose Test Systems" without any mention of human-in-the-loop assistance. The device itself performs the measurement.

7. The Type of Ground Truth Used

The type of ground truth used would have been a laboratory reference method for glucose measurement, which is the standard for validating blood glucose meters. The text implies this by stating the device is "referenced to give plasma/serum equivalent glucose results," indicating comparison to a recognized gold standard.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. For a device like a blood glucose meter, there isn't typically a "training set" in the machine learning sense. Performance is assessed against known reference values, and the device's chemical-electrical design determines its accuracy, not an algorithm "trained" on data for an initial release.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a "training set" in the context of this device's submission, there is no information on how its ground truth was established.

Summary

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510(k) SAFETY AND EFFECTIVENESS SUMMARY

Prepared:	February 26, 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:Glucometer® Elite® Blood Glucose Test SystemsGlucometer® Elite® XL Blood Glucose MeterCommon/Usual Name: Test for glucose in bloodDocument Control Number: K99 0649
Classification Name:	The GLUCOMETER ELITE Blood Glucose Test Systems and theGLUCOMETER ELITE XL Blood Glucose Meter are used as a test forglucose in blood. In 21 CFR 862.1345 a glucose test system isclassified as a Class II medical device.
Predicate Devices:	GLUCOMETER ENCORE® QA+ Blood Glucose Test System,manufactured by Bayer Corporation
Device Description:	GLUCOMETER ELITE Blood Glucose Test Systems and theGLUCOMETER ELITE XL Blood Glucose Meter are over-the-counterhome tests for glucose in blood. They are for use by persons withdiabetes and by healthcare professional in home settings and inhealthcare facilities. The GLUCOMETER ELITE Blood Glucose TestStrips are for use with the GLUCOMETER ELITE Blood Glucose Testfamily of meters.
Intended Use:	The GLUCOMETER ELITE Blood Glucose Test Systems are used forself-monitoring of blood glucose as an adjunct to the care of personswith diabetes

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Technological Characteristics:

Assessment of Performance:

An evaluation was conducted at four clinical sites to demonstrate the performance of the GLUCOMETER ELITE XL Blood Glucose Meter for use with neonatal and arterial specimens. In addition, a separate clinical study was conducted to likewise demonstrate the efficacy of the GLUCOMETER ELITE Blood Glucose Test Systems for use with arterial samples.

Conclusion:

The results of the evaluation of the GLUCOMETER ELITE XL Blood Glucose Meter demonstrate the expanded use for neonatal and arterial specimens and that that the GLUCOMETER ELITE Blood Glucose Test Systems use of arterial specimens are suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

JUL - 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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: K990649

Trade Name: Glucometer Elite Blood Glucose Test System Glucometer Elite XL Blood Glucose Meter Regulatory Class: II Product Code: CGA Dated: May 28, 1999 Received: June 2, 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 have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

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 Putman

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):

Device Name:

510(k) Number

ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺍ

GLUCOMETER ELITE® Blood Glucose Test Systems GLUCOMETER ELITE® XL Blood Glucose Meter

The GLUCOMETER ELITE Blood Glucose Test Systems Indications for Use: and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter (OTC) home testing systems for glucose in blood. These systems are for use by person with diabetes and by healthcare professionals in a home setting and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
4590649

(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 √

(Optional Format 1-2-96)

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.