ACCU-CHEK GO SYSTEM

K040796 · Roche Diagnostics Corp. · LFR · Apr 22, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040796
• Device Name: ACCU-CHEK GO SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Apr 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing.

Device Story

Modified blood glucose monitoring system; modifications include device name, size, ergonomics, test strip physical shape, handling/storage, read time, and expanded memory capacity. Device processes blood samples via test strips to provide glucose concentration readings. Used by patients or clinicians for diabetes management. Fundamental scientific technology remains unchanged from previously cleared predicate device.

Clinical Evidence

No clinical data; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing.

Technological Characteristics

Photometry-based glucose monitoring system. Uses glucose dye oxidoreductase mediator reaction test strips. Reportable range: 10-600 mg/dL. Hematocrit range: 25-65%. Operating temperature: +10° C to +40° C. Storage temperature: +2° C to +30° C.

Indications for Use

Indicated for persons with diabetes or health care professionals to quantitatively measure glucose concentration in capillary whole blood (home/clinical use) and venous blood (professional use only).

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.

Submission Summary (Full Text)

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K040796

## 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 | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Scott Thiel<br>Date Prepared: April 20, 2004 |
| 2) Device name | Proprietary name: Accu-Chek Go System<br>Classification name: Glucose dehydrogenase, glucose test system<br>(21 C.F.R. § 862.1345)(75LFR) |
| 3) Predicate device | We claim substantial equivalence to the current legally marketed Accu-Chek Compact System (K#031755). |
| 4) Device Description | Instrument Operating Principle -- photometry<br>Reagent Test Principle -- glucose dehydrogenase |
| 5) Intended use | The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale.<br>Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. |

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## 510(k) Summary, Continued

The Roche Diagnostics Accu-Chek Go (modified) System is 6) Similarities substantially equivalent to the current legally marketed Accu-Chek Compact (predicate) System. The following is a list of some of the claims and features unaffected by the proposed modification.

| Feature/Claim | Detail |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Accu-Chek Go and Accu-Chek Compact systems are<br>designed to quantitatively measure the concentration of glucose in<br>capillary whole blood. The devices are indicated for professional<br>use and over-the-counter sale. Professionals may use the test<br>strips to test capillary and venous blood samples; lay use is limited<br>to capillary whole blood testing. Both systems are indicated for<br>Alternate Site Testing use. |
| Test principle | Glucose dye oxidoreductase mediator reaction. |
| Test strip storage<br>conditions | Store at room temperature between +36° F (+2° C) and +86° F (+30° C). |
| Test strip operating<br>conditions | Between +5° F (+10° C) and +104° F (+40° C). |
| Quality control<br>testing frequency | Tests should be run with liquid quality control materials whenever a new<br>vial of test strips is opened or an unusual blood test result is obtained. |
| Quality control<br>acceptable range | The mean is strip lot specific and will be determined individually. The<br>range of the controls is within $\pm$ 15 mg/dL or $\pm$ 15% compared to the<br>determined mean. |
| Labeling<br>instructions<br>regarding expected<br>results | The normal fasting adult blood glucose range for a non-diabetic is 70-<br>105 mg/dL. One to two hours after meals, normal blood glucose levels<br>should be less than 140 mg/dL. Doctors will determine the range that is<br>appropriate for the patients. |
| Labeling<br>instructions<br>regarding response<br>to unusual results | Run a quality control test, if the result is outside the acceptable QC<br>recovery range contact Roche Diagnostics' Accu-Chek Customer Care<br>center; if result is within the acceptable range, review proper testing<br>procedure and repeat blood glucose test with a new test strip. |
| Acceptable sample<br>types | Capillary whole blood samples from a fingerstick or AST site. Venous<br>blood may also be used only if drawn by health care professionals. |
| Reportable range | 10-600 mg/dL |
| Hematocrit range | 25-65% |
| Warnings and<br>precautions | For in vitro diagnostic use only. |

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### 510(k) Summary, Continued

7) Data demonstratin g substantial equivalence

Performance testing on the modified Accu-Chek Go System demonstrated that the device meets the performance requirements for its intended use. A multi-center performance study was conducted to evaluate the accuracy and precision of the modified device. The clinical data demonstrates that the performance of the Accu-Chek Go correlates well with the laboratory plasma glucose reference test method. All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Go is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle in flight, composed of three curved lines. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

APR 2 2 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Scott Thiel Regulatory Affairs/Diabetes Specialist Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46250

k040796 Re:

Trade/Device Name: Accu-Chek Go Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR, NBW Dated: March 25, 2004 Received: March 29, 2004

Dear Mr. Thiel:

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/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, US, DVM.

Yean M. Cooper, MS, D.V.M. 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):_____________________________________________________________________________________________________________________________________________________ K040796

# Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Accu-Chek Go system is designed to quantitatively measure the concentration The Accu-Chek Go system is dealghoute to qualifically of the librath care focilition of glucose in Capillary whole Blood by person in health care facilities. The professionals for monitoning graves and over-the-counter sale.

Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

.The-Counter Use
(CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Sc

510(k) K040796