ACCU-CHEK ACTIVE SYSTEM

K011738 · Roche Diagnostics Corp. · NBW · Jun 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011738
• Device Name: ACCU-CHEK ACTIVE SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 20, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.

Device Story

Accu-Chek Active System measures glucose concentration in capillary whole blood samples. Device utilizes glucose dehydrogenase chemical reaction; instrument performs photometric analysis by measuring color change intensity proportional to glucose concentration. System intended for professional and OTC use; provides quantitative results to healthcare providers or patients for glucose monitoring. Coding procedure via code chip ensures calibration. Device supports hematocrit range 30-55% and reportable range 10-600 mg/dL. Results assist in diabetes management and clinical decision-making regarding blood glucose levels.

Clinical Evidence

Multi-center performance study evaluated accuracy and precision. Results demonstrated correlation with laboratory plasma glucose reference method. All predetermined acceptance criteria satisfied.

Technological Characteristics

Photometric glucose dehydrogenase test system. Operates via color change measurement. Reportable range 10-600 mg/dL. Hematocrit range 30-55%. Includes code chip for calibration. Operating temperature 10°C to 40°C.

Indications for Use

Indicated for professional and over-the-counter use for quantitative measurement of glucose in capillary whole blood. Not suitable for neonate 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 Simplicity System

Submission Summary (Full Text)

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K011738

JUN 2 0 2001

# 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 | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Mike Flis<br>Date Prepared: June 4, 2001 |
| 2) Device name | Proprietary name: Accu-Chek Active System<br>Classification name: Glucose dehydrogenase, glucose test system<br>(21 C.F.R. § 862.1345)(75LFR) |
| 3) Predicate<br>device | We claim substantial equivalence to the current legally marketed Accu-Chek<br>Simplicity System. |
| 4) Device<br>Description | Instrument Operating Principle -- photometry<br>Reagent Test Principle -- glucose dehydrogenase |
| 5) Intended use | The Accu-Chek Active system is designed to quantitatively measure the<br>concentration of glucose in capillary whole blood. The device is indicated for<br>professional use and over-the-counter sale. |

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#### The Roche Diagnostics Accu-Chek Active System is substantially equivalent 6) Similarities The Roone Diagnobile marketed Accu-Chek Simplicity System. The proposed to the current regarly manetees it in scope. 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 Simplicity and Accu-Chek Active systems are designed to<br>quantitatively measure the concentration of glucose in capillary whole blood.<br>The test device is indicated for professional use and over-the-counter sale. This<br>device is not suitable for testing neonate samples. |
| Test principle | Glucose dehydrogenase chemical reaction. The instrument measures the extent<br>of color change (photometric) caused by the presence of glucose in the sample.<br>The amount of color change is related to the glucose concentration in the blood<br>sample. |
| Venous blood samples | Although the method comparison studies provide evidence that the device works<br>acceptably with venous blood samples, the labeling is limited to use with<br>capillary whole blood. |
| Monitor coding<br>procedure | Code chip is provided with each carton of test strips. |
| 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 testing<br>frequency | Tests should be run with liquid quality control materials whenever a new vial of<br>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 range of<br>the controls is within ± 15 mg/dL or ± 15% compared to the determined mean. |
| Labeling instructions<br>regarding expected<br>results | The normal fasting adult blood glucose range for a non-diabetic is 70-105<br>mg/dL. One to two hours after meals, normal blood glucose levels should be<br>less than 140 mg/dL. Doctors will determine the range that is appropriate for the<br>patients. |
| Labeling instructions<br>regarding response to<br>unusual results | Run a quality control test, if the result is outside the acceptable QC recovery<br>range contact Roche Diagnostics's Accu-Chek Customer Care center; if result is<br>within the acceptable range, review proper testing procedure and repeat blood<br>glucose test with a new test strip. |
| Acceptable sample<br>types | Capillary whole blood samples |
| Reportable range | 10-600 mg/dL |
| Hematocrit range | 30 - 55% |
| Warnings and<br>precautions | For in vitro diagnostic use only. |

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### 510(k) Summary, Continued

7) Data demonstrating substantial equivalence

Performance testing on the modified Accu-Chek Active 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 Active correlates well with the laboratory plasma glucose reference test method. All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Active 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 consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

JUN 2 0 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics corporation 9115 Hague Road Indianapolis, IN 46250

Re: 510(K) Number: K011738 Trade/Device Name: Accu-Chek Active Test System Regulation Number: 862.1345 Regulatory Class: II Product Code: NBW, LFR Dated: June 4, 2001 Received: June 5, 2001

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 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). 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 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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#### Page 2

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 predication. The 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, (Jease contact the Office of Compliance at [phone]. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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): Kou1738 Device Name: Accu-Chek Active Test System

Indications for Use:

The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Fred Lacy

(Division Sign-Off Division of Clinica Laboratory Devices K011738 510(k) Number.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)