GLUCOMETER DEX TEST SENSOR

K012205 · Bayer Corp. · NBW · Sep 12, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012205
• Device Name: GLUCOMETER DEX TEST SENSOR
• Applicant: Bayer Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The GLUCOMETER® DEX® Blood Glucose Test System is for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.

Device Story

The Glucometer Dex Test Sensor is a consumable component used with the Glucometer Dex family of blood glucose meters. It accepts whole blood samples; utilizes an amperometric glucose oxidase method to measure glucose concentration; and provides a quantitative blood glucose result. The system is used by patients with diabetes for self-monitoring and by healthcare professionals in clinical settings. The output is displayed on the meter, allowing patients and providers to monitor glucose levels and adjust diabetes management accordingly.

Clinical Evidence

Performance was evaluated in both in-house and clinical settings by healthcare professionals and persons with diabetes. Studies demonstrated satisfactory performance and suitability for the intended use. No specific statistical metrics (e.g., sensitivity, specificity) were provided in the summary.

Technological Characteristics

Amperometric glucose oxidase method; linear response range 10-600 mg/dL; results referenced to plasma glucose. Sensors are individually sealed in cartridges of ten. Standalone use with Glucometer Dex meters.

Indications for Use

Indicated for persons with diabetes and healthcare professionals in clinical settings to measure glucose levels in whole blood as an adjunct to diabetes care. Suitable for home (OTC) and clinical use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• GLUCOMETER® DEX Test Sensor Disc

Submission Summary (Full Text)

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SEP 1 2 2001

GLUCOMETER® DEX® TEST SENSOR
GLUCOMETER® DEX® TEST SENSOR
GLUCOMETER® DEX® TEST SENSOR Page 1 of 2

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Prepared: | July 13, 2001 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bayer Diagnostics |
| Address: | 1884 Miles Avenue<br>P.O. Box 70<br>Elkhart, IN 46515<br>[phone] |
| Contact: | George M. Tancos R.A.C.<br>Manager, Regulatory Compliance |
| Device: | Trade/Proprietary Name: GLUCOMETER ®DEX® TEST SENSOR<br>Common/Usual Name: Test for glucose in whole blood<br>Document Control Number: K01 2205 |
| Classification Name: | The GLUCOMETER® DEX® Test Sensor Disc and the<br>GLUCOMETER® DEX family of blood glucose meters are used to test<br>for glucose in blood. In 21 CFR 862.1345, a glucose test system is<br>classified as a Class II medical device. |
| Predicate Devices: | GLUCOMETER® DEX Test Sensor Disc |
| Manufactured by: | Bayer Diagnostics<br>430 S. Beiger St.<br>Mishawaka, IN 46544 |
| Device Description: | The GLUCOMETER ® DEX® Test Sensor (modified) is for use with the<br>GLUCOMETER® DEX® family of Blood Glucose Meters. The<br>GLUCOMETER DEX Blood Glucose Test System is an over-the-counter<br>(OTC) home test for glucose in blood. The system is used by persons<br>with diabetes and by healthcare professionals in home settings and in<br>healthcare facilities. |
| Intended Use: | The GLUCOMETER® DEX® Blood Glucose Test System is for the<br>self-monitoring of blood glucose as an adjunct to the care of persons<br>with diabetes. |

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| Technological Characteristics: | The GLUCOMETER® DEX® Blood Glucose Test<br>employs and amperometric glucose oxidase method to<br>measure glucose in blood. It is conceptually the same as<br>other blood glucose monitoring products available for<br>blood glucose testing. The Test Sensors are individually<br>sealed in cartridges of ten sensors. Blood glucose results<br>are referenced to plasma glucose. The<br>GLUCOMETER® DEX® Blood Glucose System has a<br>linear response to glucose from 10-600 mg/dL. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assessment of Performance: | The performance of the GLUCOMETER® DEX® Test<br>Sensor (modified) was studied in both in-house and<br>clinical settings by healthcare professionals and by<br>persons with diabetes. The studies demonstrated that the<br>GLUCOMETER® DEX® Test Sensor (modified) is<br>suitable for its intended use. |
| Conclusion: | The results of the evaluation of the GLUCOMETER®<br>DEX® Test Sensor (modified) demonstrate satisfactory<br>performance, and are suitable for their intended use. |

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SEP 1 2 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K012205 Re:

Trade/Device Name: Glucometer ® Dex® Test Sensor Regulation Number: 21 CFR 862.1345 Regulatory Class: II Product Code: NBW Dated: July 13, 2001 Received: July 16, 2001

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 to 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/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): K01 220 5

Device Name:

Indications for Use:

## GLUCOMETER® DEX® TEST SENSOR

The GLUCOMETER® DEX® TEST SENSOR is used with the GLUCOMETER® DEX® and GLUCOMETER® DEX®2 Blood Glucose Meters to measure the glucose level in whole blood. The GLUCOMETER® DEX Blood Glucose System is a home use (OTC) device used by persons with diabetes, and by health care professionals in clinical settings for the selfmonitoring of blood glucose as an adjunct to the care of persons with diabetes.

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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)

PageX

Kesia Alexander for Sean Cooper

Division of Clinical Laboratory Devices 012 206 510(k) Number