ACCU-CHEK COMFORT CURVE TEST STRIP

K982002 · Boehringer Mannheim Corp. · LFR · Sep 2, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982002
• Device Name: ACCU-CHEK COMFORT CURVE TEST STRIP
• Applicant: Boehringer Mannheim Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Sep 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Accu-Chek Comfort Curve Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete systems are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.

Device Story

Test strips used with Accu-Chek Advantage and Accu-Chek Complete monitors; measure blood glucose in whole blood samples. Device utilizes a modified reference curve within the monitor's code key to convert whole blood glucose measurements to plasma-equivalent glucose values, aligning results with laboratory standards. Used by patients with diabetes (home) or healthcare professionals (clinical settings). Output displayed on monitor screen; assists in diabetes management by providing plasma-referenced glucose concentrations. Benefits include improved consistency between home/point-of-care testing and laboratory results.

Technological Characteristics

Glucose dehydrogenase-based test strip for whole blood glucose measurement. System utilizes a code key to calibrate the monitor's reference curve. Designed for use with Accu-Chek Advantage and Accu-Chek Complete monitors.

Indications for Use

Indicated for blood glucose testing in patients with diabetes. Lay users limited to capillary blood testing; healthcare professionals may test capillary, venous, arterial, and neonate (including cord) blood samples.

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

• Accu-Chek® Comfort Curve™ Test Strip (K980731)

Submission Summary (Full Text)

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## Accu-Chek® Comfort Curve™ Test Strip

## 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Boehringer Mannheim Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] |
| | Contact Person:<br>Mike Flis |
| | Date Prepared:<br>June 5, 1998 |
| 2) Device name | Proprietary name: Accu-Chek® Comfort Curve™ Test Strip<br>Common name: Blood glucose test system<br>Classification name: glucose dehydrogenase, glucose |
| 3) Predicate<br>device | We claim substantial equivalence to the unmodified Accu-Chek® Comfort<br>Curve™ Test Strip. |
| 4) Device<br>Description | The Accu-Chek Comfort Curve Test Strips are to be used with the Accu<br>Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu<br>Chek Comfort Curve test strips are designed for convenient, confident, and<br>accurate testing of blood glucose in whole blood samples. |
| | Continued on next page |

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## 510(k) Summary, Continued

| 5) Intended use | The Accu-Chek Comfort Curve Test Strips are to be used with the Accu-<br>Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-<br>Chek Advantage and Accu-Chek Complete systems are designed for testing<br>glucose in whole blood by persons with diabetes or by health care<br>professionals in the home or in health care facilities.<br>Professionals may use the test strips to test capillary, venous, arterial and<br>neonate (including cord) blood samples; lay use is limited to capillary blood<br>testing. |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Comparison<br>to predicate<br>device | The modified Boehringer Mannheim Accu-Chek Comfort Curve Test Strip is<br>substantially equivalent to other products in commercial distribution intended<br>for similar use. Most notably it is substantially equivalent to the previously<br>510(k) cleared Accu-Chek Comfort Curve Test Strip (k980731).<br>Blood glucose concentrations can be expressed two ways, as whole blood<br>glucose or as plasma (or serum) glucose. The concentration of glucose in<br>whole blood is lower (by about 8%) than the plasma glucose value for this<br>same blood sample because of the differences in distribution of water between<br>the two compartments (red blood cells and plasma). Test strips developed for<br>the measurement of whole blood samples were traditionally referenced to<br>provide a whole blood glucose value. However, many North American<br>laboratories have, for the last few decades, routinely measured and reported<br>only the plasma glucose values. Recent advancements in the management of<br>patients with diabetes have created a preference to have the results for blood<br>glucose test strips reflect the laboratory plasma value instead of the more<br>traditional whole blood value. For this reason Boehringer Mannheim has<br>modified the reference curve employed within the code key used with the<br>Accu-Chek Comfort Curve test strips to now provide results which reflect the<br>higher laboratory plasma glucose value. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

3 1098 SEP

Mike Flis Regulatory Affairs Specialist Boehringer Mannheim 9115 Haque Road P.O. Box 50457 46250-0457 Indianapolis, Indiana

Re : K982002 Accu-Chek® Comfort Curve™ Test Strip Requlatory Class: II Product Code: LFR Dated: June 5, 1998 Received: June 8, 1998

Dear Mr. Flis:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling; and mann prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 In addition, FDA may publish further announcements action. 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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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 [phone].

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 [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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Gutman

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: Accu-Chek® Comfort Curve™ Test Strip Indications for Use:

The Accu-Chek Comfort Curve Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete systems are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.

Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number_k

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)