GLUCOTREND BASIC SYSTEM

K972876 · Boehringer Mannheim Corp. · LFR · Oct 9, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972876
• Device Name: GLUCOTREND BASIC SYSTEM
• Applicant: Boehringer Mannheim Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Oct 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Glucotrend Basic System is designed for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.

Device Story

Glucotrend Basic System is a self-monitoring blood glucose test system. It utilizes a photometric measurement principle to determine glucose levels from capillary or venous blood samples (minimum 3 µL). The system consists of a monitor and reagent test strips. It is intended for use by patients with diabetes or healthcare professionals in home or clinical environments. The user applies a blood sample to the test strip; the monitor performs a photometric analysis and displays the glucose concentration. Results assist in diabetes management. The device provides a visual result back-up via color blocks on the strip canister.

Clinical Evidence

Clinical accuracy was evaluated by comparing the Glucotrend Basic System against reference laboratory methods. Studies included trained healthcare professionals (N=202 capillary, N=104 venous) and consumers (N=134). Correlation coefficients (r) ranged from 0.976 to 0.995. Precision was assessed using control solutions and venous blood samples across multiple concentration levels, with standard deviations ranging from 1.2 to 3.4 mg/dL.

Technological Characteristics

Photometric sensing principle; glucose dehydrogenase reagent chemistry; 3 µL minimum sample volume; 10°C to 40°C operating temperature range; 30-57% hematocrit range; 9500 feet altitude limit; visual result back-up via color blocks.

Indications for Use

Indicated for blood glucose monitoring in patients with diabetes, for use by patients at home or by healthcare professionals in clinical settings.

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

• Boehringer Mannheim Accu-Chek Advantage System with the Advantage H Test Strip (K972876)

Submission Summary (Full Text)

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OCT - 9 1997

Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

| 1) Submitter name, address, contact | Boehringer Mannheim Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Mike Flis |
| | Date Prepared: August 01, 1997 |
| 2) Device name | Proprietary name: Glucotrend ^TM Basic System |
| | Common name: self-monitoring blood glucose test system |
| | Classification name: Blood glucose test |
| 3) Predicate device | We claim substantial equivalence to the Boehringer Mannheim Accu-Chek Advantage System with the Advantage H Test Strip. |

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510(k) Summary

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| 4) Device<br>Description | Instrument Operating Principle -- photometric<br>Reagent Test Principle -- glucose deoxy reductase | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| 5) Intended use | The Glucotrend Basic System is designed for testing glucose by persons with<br>diabetes or by health care professionals in the home or in health care facilities | | |
| 6) Comparison<br>to predicate<br>device | The Boehringer Mannheim Glucotrend Basic System is substantially<br>equivalent to other products in commercial distribution intended for similar<br>use. Most notably it is substantially equivalent to the currently marketed<br>Boehringer Mannheim Accu-Chek Advantage System with the Advantage H<br>Test Strip. | | |
| Similarities to<br>Predicate<br>Device | - Intended use (blood glucose monitoring) | | |
| | - Closed system (instrument and reagents are provided by BMC and are<br>intended to only be used in conjunction with each other) | | |
| | - Glucose dehydrogenase test principle | | |
| | - Verified reportable range (10 to 600 mg/dL) | | |
| | - Test strip packaging (desiccated vials with multiple strips) | | |
| | - Test strip storage conditions | | |
| | - Recommended quality control testing procedure | | |
| | - Specimen collection and preparation instructions | | |
| | - Monitor requires no scheduled maintenance other than cleaning | | |
| | - Instructions regarding response to unusual results | | |
| | - Warnings and precautions | | |
| | - Results referenced to whole blood laboratory testing | | |

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#### Differences

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| Feature | Accu-Chek Advantage<br>System with the<br>Advantage H Test<br>Strip (predicate) | Glucotrend Basic<br>(new device) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Instrument operating<br>principle | amperometric | photometric |
| Blood sample types | capillary, venous,<br>arterial, and neonate | capillary and venous |
| Minimum sample<br>volume | 9 µL | 3 µL |
| Operating temperature<br>range | 14°C to 40°C | 10°C to 40°C |
| Hematocrit range | 20-65% at <200 mg/dL<br>25-55% at >200 mg/dL | 30-57% |
| Maximum altitude<br>verified | 10,150 feet | 9500 feet |
| Visual result back-up | None | Blank + 5 color blocks<br>on strip canister |
| Interferences | Low concentration:<br>· Xylose<br>High concentration:<br>• Uric Acid<br>· Galactose<br>· Lipemic sample ><br>5000 mg/dL | Low concentration:<br>· Xylose<br>High concentration:<br>• Uric Acid<br>· Galactose |

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#### Performance

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Characteristics

Accuracy

| Parameter | Accu-Chek Advantage<br>System with the<br>Advantage H Test<br>Strip (predicate) | Glucotrend Basic<br>(new device) |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Trained health care<br>professional versus<br>reference<br>(Capillary blood) | N = 166<br>y = 0.99x + 5.0<br>r = 0.973<br>range = 43 to 478 mg/dL | N = 202<br>y = 1.02x + 2.6<br>r = 0.989<br>range = 51 to 490 mg/dL |
| Trained health care<br>professional versus<br>reference<br>(Venous blood) | N = 166<br>y = 1.05X - 0.6<br>r = 0.990<br>range = 40 to 457 mg/dL | N = 104<br>y = 1.029 x + 2.7<br>r = 0.995<br>range = 35 to 483 mg/dL |
| Arterial blood study | N = 206<br>y = 1.06x - 3.5<br>r = 0.973 | not applicable |
| Neonate blood study | N = 303<br>y = 0.98x + 2.81<br>r = 0.94<br>range = 20 to 305 mg/dL<br>hematocrit range = 26 to<br>69% | not applicable |
| Consumers versus<br>reference | Not performed--claim<br>data from glucose oxidase<br>test strip supports OTC<br>use | N = 134<br>y = 1.082x - 2.9<br>r = 0.976<br>range = 58 to 357 mg/dL |

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#### Performance

Characteristics,

Contd.

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Precision

| Parameter | Accu-Chek Advantage<br>System with the<br>Advantage H Test<br>Strip (predicate) | Glucotrend Basic<br>(new device) |
|---------------------------------------|---------------------------------------------------------------------------------|----------------------------------|
| | N = 96/Level (Control)<br>N = 60/Level (Blood) | N = 20/Level |
| Control Level 1<br>•Mean (mg/dL) | 42.0 | 84.0 |
| •Standard Deviation (SD) | 4.2 | 2.0 |
| Control Level 2<br>•Mean (mg/dL) | 104.0 | 196.4 |
| •Standard Deviation (SD) | 3.0 | 2.5 |
| Venous Blood Level 1<br>•Mean (mg/dL) | 53.0 | 28.7 |
| •Standard Deviation (SD) | 3.9 | 1.2 |
| Venous Blood Level 2<br>•Mean (mg/dL) | not applicable | 87.3 |
| •Standard Deviation (SD) | | 2.6 |
| Venous Blood Level 3<br>•Mean (mg/dL) | not applicable | 129.4 |
| •Standard Deviation (SD) | | 3.0 |
| Venous Blood Level 4<br>•Mean (mg/dL) | 233.0 | 229.2 |
| •Standard Deviation (SD) | 2.9 | 2.8 |
| Venous Blood Level 5<br>•Mean (mg/dL) | 490.0 | 335.0 |
| •Standard Deviation (SD) | 3.6 | 3.4 |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 9 1997

Mr. Mike Flis Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46250

Re : K972876 Glucotrend™ Basic System Trade Name: Requlatory Class: II Product Code: LFR Dated: July 31, 1997 Received: August 4, 1997

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 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 requirement, 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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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 requlation 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 at [phone] or at its internet address "http://www.fda.qov/cdrh/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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### Indications for Use Statement

### 510(k) Number (if known): Device Name: Glucotrend Basic System

Indications for Use:

The Glucotrend Basic System is designed for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.

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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)

(Division Sign-Off)
Division of Clinical Laboras vices
510(k) Number K972876
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