ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS

K973662 · Boehringer Mannheim Corp. · LFR · Dec 15, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973662
• Device Name: ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
• Applicant: Boehringer Mannheim Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Dec 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Accu-Chek Complete System is intended for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.

Device Story

Accu-Chek Complete Meter is an in vitro diagnostic device for measuring whole blood glucose concentrations. It utilizes Accu-Chek Advantage or Advantage H test strips. Principle of operation is electrochemical biamperometry: meter applies voltage between two electrodes to measure current generated by oxidized mediator during incubation. Device is used by patients with diabetes or healthcare professionals in homes or clinical facilities. Meter features include data storage (1000 records), statistical calculations (average, min, max), and RS232 data port for connectivity. User interface includes 3-button navigation and LCD display with numeric, icon, and graphical output. Device provides glucose readings to assist in diabetes management. Fail-safe mechanisms include temperature, range, strip, checksum, calibration, battery, and serial communication error detection.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Electrochemical biamperometry sensing principle. Powered by two AAA alkaline batteries. Dimensions: 120.50 x 71.98 x 25.98 mm. Weight: 3.5 oz. Connectivity: RS232 data port. Operating conditions: 57°F to 104°F, <85% RH. Storage conditions: -13°F to 149°F, <95% RH. Fail-safe mechanisms include temperature, range, strip, checksum, calibration, battery, and serial communication error detection.

Indications for Use

Indicated for glucose testing in persons with diabetes or by healthcare professionals in home or clinical settings. Over-the-counter use with capillary blood samples. Professional use with capillary, venous, arterial, and neonate blood samples (when using Accu-Chek H Test Strips).

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 Advantage System (K930979, K951887, K954833)

Submission Summary (Full Text)

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K973662
Dec. 15, 1997

# 510(k) Summary

| 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]<br><br>Contact Person: Mike Flis<br><br>Date Prepared: |
| 2) Device name | Proprietary name: Accu-Chek Complete Meter<br><br>Common name: Blood glucose test system<br><br>Classification name: glucose dehydrogenase, glucose |
| 3) Predicate device | We claim substantial equivalence to the Boehringer Mannheim Accu-Chek Advantage System. 510(k) files #k930979, #k951887, and #k954833. |
| 4) Device Description | The Accu-Chek Complete Meter is an invitro device designed for measuring the concentrations of glucose in whole blood which is applied to Accu-Chek Advantage or Accu-Chek Advantage H Test Strips. |
| | Continued on next page |

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### 510(k) Summary, Continued

The Accu-Chek Complete System is designed for testing glucose by persons 5) Intended use with diabetes or by health care professionals in the home or in health care facilities. The Boehringer Mannheim Accu-Chek Complete System is substantially 6) Comparison equivalent to other products in commercial distribution intended for similar to predicate use. Most notably it is substantially equivalent to the currently marketed device Accu-Chek Advantage System.

Continued on next page

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## 510(k) Summary, Continued

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| Similarities to<br>Predicate<br>Device | Intended use [testing glucose in whole blood by persons with diabetes or<br>by health care professionals in the home or health care facilities]<br>Indicated for over-the-counter use with capillary blood samples only<br>[Accu-Chek Advantage and Accu-Chek Advantage H Test Strips]<br>Indicated for use with capillary, venous, arterial, and neonate blood<br>samples by professionals (only applies to use with Accu-Chek H Test<br>Strips) -- professional use with Accu-Chek Advantage Test Strips is<br>limited to capillary blood samples<br>Glucose dehydrogenase or glucose oxidase test strip (test principle) is<br>unchanged - meter will operate with either strip version<br>Meter operating procedure unchanged [The Advantage Test Strip<br>employs the electrochemical principle of biamperometry. The monitor<br>applies a voltage between two identical electrodes, the causes the<br>reduced mediator formed during the test's incubation period to be<br>reconverted to oxidized mediator. This generates a small current that is<br>read by the meter.]<br>Meter coding procedure unchanged<br>Test strip dosing location remains outside the monitor -- meaning no<br>strip guide or monitor optics cleaning required. Meter cleaning [Damp<br>cloth of 10% bleach solution] and troubleshooting procedures<br>unchanged.<br>Meter storage condition limits unchanged [-13°F to 149°F, <95% RH]<br>Meter operating condition limits unchanged [57°F to 104°F, <85% RH]<br>Errors are depicted on LCD display and viaaudible beeps<br>All test strip and liquid controls related directions for use and claims<br>unchanged<br>Limitations of procedure (including system measurement range)<br>unchanged<br>Expected results unchanged<br>Instructions regarding response to unusual results unchanged<br>Warnings and precautions unchanged<br>Results referenced to whole blood laboratory testing unchanged<br>Continued on next page |
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പ്രവാഹ്യം

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## 510(k) Summary, Continued

#### Differences

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| Feature | Accu-Chek Advantage<br>Meter (predicate) | Accu-Chek Complete<br>(new device) |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fail-safe Mechanisms | • Out of temperature range<br>• Out of reporting range<br>• Erroneous strip insert<br>• Memory Checksum<br>• Calibration code error<br>• Low battery voltage | • Out of temperature range<br>• Out of reporting range<br>• Erroneous strip insert<br>• Memory Checksum<br>• Calibration code error<br>• Low battery voltage<br>• Serial Communication<br>Error Detector |
| Calculations other than blood<br>glucose test | None | Average, Minimum, and<br>Maximum values for 2 days,<br>7 days, 14 days, 30 days |
| Meter size | 91.4 x 50.8 x 15.2 mm | 120.50 x 71.98 x 25.98 mm |
| Display viewing size | 40.6 x 35.6 mm | 52 x 34.7 mm |
| Weight | 3 oz. with batteries | 3.5 oz. without batteries |
| Power supply | Two 3-volt lithium coin cell<br>batteries | Two AAA alkaline batteries |
| Data display | Numeric/Icon | Numeric/Icon/Graph |
| bG data stored in memory | mg/dl | mg/dl or mmol/l |
| Type of non-bG data stored | None | Carbohydrates, insulin,<br>HbA1c, ketones, other<br>indices |
| Memory capacity | 100 blood glucose results<br>with time and date | 1000 data records |
| Data port | Multiplexed TTL UART | RS232 |
| Buttons | 2 "ON/OFF" and "MEM" | 3 - multiple function<br>corresponding to screen<br>display |
| Turn On | Press "ON/OFF" button | Press any button or insert<br>test strip |

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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DFC 1 5 1997

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

Re : K973662 Accu-Chek® Complete™ System Requlatory Class: II Product Code: LFR, CGA Dated: October 23, 1997 Received: October 24, 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 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 requlations.

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

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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973662

510(k) Number (if known): 310(K) Name: Accu-Chek Complete System Indications for Use:

The Accu-Chek Complete System is intended 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)

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number 773667

Prescription Use (Per 21 CFR 801.109)

OR

Image /page/6/Picture/9 description: The image shows the text "Over-The-Counter Use" with a check mark next to it. The text is written in a simple, sans-serif font and is left-aligned. The check mark is drawn with a thick line and is positioned to the right of the text, indicating that the option has been selected.

(Optional Format 1-2-96)