ACCU-CHEK AVIVA TEST STRIPS

K060620 · Roche Diagnostics Corp. · NBW · Aug 11, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060620
• Device Name: ACCU-CHEK AVIVA TEST STRIPS
• Applicant: Roche Diagnostics Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ACCU-CHEK Aviva Test Strips are used with the ACCU-CHEK Aviva meter. The ACCU-CHEK Aviva test system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf. Professionals may use the test strips to test capillary, venous, arterial, and neonate samples; home use is limited to capillary whole blood testing.

Device Story

System uses reagent test strips and meter to measure blood glucose; glucose dehydrogenase enzyme converts glucose to gluconolactone; reaction liberates electrons; electrochemical biamperometry measures current generated by mediator reconversion; meter reports glucose concentration. Used in home or clinical settings by patients or professionals. Provides plasma-equivalent results. Enables monitoring of glucose levels for diabetes management; supports expanded sample types (arterial, neonatal capillary, neonatal cord) and hematocrit range (10-70%).

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and performance characteristics comparing the subject device to the predicate system.

Technological Characteristics

Glucose dehydrogenase electrochemical biamperometry. Reagent test strips with hexacyanoferrate mediator. Meter applies voltage to electrodes to measure current. Hematocrit range 10-70%. Reportable range 10-600 mg/dL. Battery-powered handheld meter.

Indications for Use

Indicated for quantitative glucose monitoring in patients with diabetes. Professionals may test capillary, venous, arterial, and neonatal blood. Home use is restricted to capillary whole blood testing.

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 Aviva system (K043474)

Submission Summary (Full Text)

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K060620

AUG 1 1 2006

| 510(k) Summary | | AUG 11 2006 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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 46256<br>[phone] | |
| | Contact Person: Scott Thiel / Luann Ochs | |
| | Date Prepared: August 3, 2006 | |
| 2) Device name | Proprietary name: ACCU-CHEK® Aviva Test Strips | |
| | Common name: Whole blood glucose test system | |
| | Classification name: 75, LFR, Glucose Dehydrogenase, glucose | |
| 3) Predicate<br>device | The Roche Diagnostics ACCU-CHEK Aviva system cleared under K043474<br>on April 27, 2005. | |
| 4) Device<br>Description | The ACCU-CHEK Aviva Test Strips are stored within a desiccated vial. A<br>test strip is removed from the vial and inserted into the meter. Upon<br>insertion, the meter is activated. Blood is applied to the end of the test strip,<br>and a glucose result is reported. | |
| | The test principle is: | |
| | Blood from the test site works with the chemicals in the test strip to make a<br>small electrical current in the test strip. The meter reads the current and gives<br>a blood glucose results. | |

Continued on next page

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The ACCU-CHEK Aviva Test Strips are used with the ACCU-CHEK Aviva 5) Intended use meter. The ACCU-CHEK Aviva system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.

> Professionals may use the test strips to test capillary, venous, arterial, and neonate samples; home use is limited to capillary whole blood testing.

The proposed modification is relatively modest in scope. The following is a 6) Similarities to predicate list of some of the claims and features unaffected by the proposed device modifications.

| Feature/Claim | Detail |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Both systems are intended for testing glucose in whole blood by<br>persons with diabetes or by health care professionals in the home or in<br>health care facilities. |
| Closed System | Each system's test strips and controls are designed to be used only with<br>that system. |
| Test Principle | Chemicals in the test strip make a small electric current in the test strip<br>when dosed with a sample. The meter reads the current and gives a<br>blood sugar result. |
| Test Strip storage<br>conditions | Store the test strips at room temperature (less than 90°F); do not freeze. |
| Quality control<br>procedures | User is directed to perform quality control testing: when the cap is left<br>off the vial of test strips, when a new vial is opened, if the meter is<br>dropped, if the result does not agree with the way the user feels,<br>whenever the user wishes to check the performance of the system. |
| Altitude | 10,150 feet |
| Reportable range | 10 - 600 mg/dL |
| Warnings and<br>precautions | Both systems are for in vitro diagnostic use only. |
| Active reagent<br>composition | Glucose dehydrogenase |
| Monitor coding<br>process | Both systems use a code key, included in the test strip vial, inserted into<br>the meter. |
| Test strip packaging | Both systems provide test strips in a desiccated vial. |
| Identification of<br>control solutions | Both systems automatically distinguish control solutions from whole<br>blood samples. |

Continued on next page

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## 510(k) Summary, Continued

6) Similarities to predicate device, cont.

Feature/Claim Detail Test sample volume 0.6 µL Test time 5 seconds Expiration In addition to information included in labeling, the code key contains expiration date of associated test strips. System informs user when code key has expired. The system utilizes both AC/DC electrical impedance information. Test strip technology The normal fasting blood glucose range for an adult without diabetes Labeling instructions is 74 - 106 mg/dL. Two hours after meals, the blood glucose range regarding expected for an adult without diabetes is less than 140 mg/dL. For people with results diabetes: consult your doctor for the blood glucose range appropriate for you.

6) Difference to predicate device

| Topic | ACCU-CHEK Aviva Pro Test<br>Strips | ACCU-CHEK Aviva |
|--------------|-----------------------------------------------------------|-----------------------------------------------|
| Sample Types | Whole blood (capillary, venous,<br>arterial, and neonate) | Whole blood samples (capillary<br>and venous) |
| Hematocrit | 10 - 70% | 20 - 70% |

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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 eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Scott Thiel, MT(ASCP), MBA Regulatory Affairs Program Principal Roche Diagnostics, Inc. 9115 Hague Road Indianapolis, IN 46250-0416

AUG 1 1 2006

Re: k060620

Trade/Device Name: ACCU-CHEK® Aviva Test Strips Regulation Number: 21 CFR8862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR, NBW Dated: July 24, 2006 Received: July 25, 2006

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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## Page 2 -

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/industry/support/index.html.

Sincerely yours,

Alberto Garcia, Ph.D.

Alberto Gutierrez, Ph.D. 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):__ K060620

Device Name: ____ ACCU-CHEK® Aviva Test Strips

Indications For Use:

The ACCU-CHEK Aviva Test Strips are used with the ACCU-CHEK Aviva meter. The ACCU-CHEK Aviva test system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.

Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.

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

Over-The-Counter Use (21 CFR 801 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)

C.A.C. i

Office of Home - Domestic Device

510(k) k060620

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