ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080

K062058 · Bayer Healthcare · NBW · Sep 11, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062058
• Device Name: ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
• Applicant: Bayer Healthcare
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Shogun Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Shogun Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The Shogun Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples and neonatal blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the case of neonates, the heel. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Device Story

System measures glucose in whole blood; includes meter, test strips, control solution, lancing device, and lancets. Used by patients with diabetes or healthcare professionals in home/clinical settings. Provides blood glucose readings to assist in diabetes management. Modifications from predicate include meter design, software, and labeling changes; fundamental scientific technology remains unchanged.

Clinical Evidence

Laboratory and clinical evaluations compared the modified system to the original Ascensia CONTOUR system and a laboratory reference method. Results demonstrated equivalent performance.

Technological Characteristics

Glucose dehydrogenase-based blood glucose monitoring system. No changes to fundamental scientific technology. Includes meter, test strips, control solution, and lancing accessories.

Indications for Use

Indicated for persons with diabetes and healthcare professionals in home/clinical settings for glucose measurement in capillary, venous, arterial, and neonatal whole blood. Capillary sites include fingertip, palm, forearm, and neonatal heel.

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

• Ascensia® CONTOUR® Diabetes Care System (k023657, k060470)

Submission Summary (Full Text)

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Bayer HealthCare Diabetes Care Division

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SEP 1 1 2006

### 510(k) SUMMARY

## Ascensia Contovr® Blood Glucose Monitoring System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K062058.

| Prepared: | August 4, 2006 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bayer HealthCare, Diabetes Care Division |
| Address: | 430 South Beiger Street<br>Mishawaka, IN 46544<br>Phone [phone]; FAX [phone] |
| Contact: | Roger Sonnenburg, Regulatory Affairs Manager |
| Device: | Trade/Proprietary Name: Ascensia® CONTOUR® Blood<br>Glucose Monitoring System |
| Common/Usual Name: | Blood Glucose Meter |
| Classification: | Division of Clinical Laboratory Devices<br>Panel - Clinical Chemistry and Toxicology<br>Classification Code – 75 LFR, Glucose Dehydrogenase,<br>Glucose |
| Predicate Device: | Ascensia® CONTOUR® Diabetes Care System, K023657 |
| Device Description: | The Ascensia® CONTOUR® Blood Glucose Monitoring System<br>is used for the measurement of glucose in whole blood. The<br>system contains a blood glucose meter, a bottle of strips, a<br>bottle of normal control solution, a lancing device and lancets<br>and instructions for use. |

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# Ascensia Page 2 of 2

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| Intended Use: | The Shogun Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Shogun Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The Shogun Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples and neonatal blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the case of neonates, the heel. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes. |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | There were no changes to the fundamental scientific technology. |
| Comparison to Predicate device: | The modifications to the device encompass meter design changes, software changes, and labeling changes. There has been no change to the intended use, operating principle, or functionality of the device. |
| Assessment of Performance: | An evaluation of the Ascensia ^® CONTOUR ^® Blood Glucose Monitoring System was studied in the laboratory and in a clinical setting by persons with diabetes. The results were compared to results from the original Ascensia ^® CONTOUR ^® Blood Glucose Monitoring System and to a laboratory method. The studies showed equivalent performance with the original Ascensia ^® CONTOUR ^® Blood Glucose Monitoring System. |
| Conclusion: | The results of the laboratory and clinical evaluations of the Shogun Blood Glucose Monitoring System demonstrated that the device produces blood glucose results that are substantially equivalent to results obtained on the predicate device. Therefore, the system with the modified meter is as safe and effective as the original system. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, clutching a staff with a snake wrapped around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

#### SEP 1 1 2006

Mr. Roger Sonnenburg Bayer Healthcare LLC Diabetes Care Division 430 South Beiger Street Mishawaka, IN 46544

Re: k062058

> Trade/Device Name: Ascensia® CONTOUR ® Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR Dated: July 19, 2006 Received: July 20, 2006

Dear Mr. Roger Sonnenburg:

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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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gu

Alberto Gutierrez, Ph.D. 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): K062058

Device Name: Ascensia CONTOUR® Blood Glucose Monitoring System

Indications For Use: The Ascensia® CONTOUR®Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.

> The Ascensia CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples and neonatal blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the case of neonates, the heel.

The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Carol Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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K062058