ACCU-CHEK AVIVA SYSTEM

K043474 · Roche Diagnostics Corp. · LFR · Apr 27, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043474
• Device Name: ACCU-CHEK AVIVA SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The ACCU-CHEK® Aviva 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 blood glucose in the home or health care facility. The device is intended for professional use and over-the-counter sale. Professionals may use the test strip to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.

Device Story

The ACCU-CHEK Aviva system is a blood glucose monitoring device for home or clinical use. It consists of a meter, reagent test strips, control solutions, and a lancing device. The user inserts a test strip into the meter, applies a capillary blood sample (0.6 μL) to the strip, and the meter provides a quantitative glucose result in 5 seconds. The system uses glucose dehydrogenase technology and electrochemical biamperometry to measure glucose concentration. It automatically distinguishes between blood samples and control solutions. The device provides plasma-equivalent results. Healthcare providers use these results to monitor glycemic control in patients with diabetes. The system includes an expiration notification feature linked to the test strip code key.

Clinical Evidence

Bench testing only. Precision studies (N=10 per level) showed CVs ranging from 1.5% to 4.21%. Linearity established across 3-677 mg/dL. Method comparison with reference method (N=97) yielded R=0.982. Matrix comparison (N=212 capillary, N=227 venous) showed high correlation (R≥0.994). Alternate site testing (AST) accuracy study (N=pooled data) showed 3.2% of results outside ISO 15197 criteria, meeting the 5% acceptance threshold. Hematocrit range tested: 23-51%.

Technological Characteristics

Glucose dehydrogenase-based electrochemical test system. Utilizes AC/DC electrical impedance for glucose measurement and environmental compensation. Features code key-based calibration, desiccated test strip vials, and automated expiration tracking. Dimensions/materials not specified. Standalone meter operation.

Indications for Use

Indicated for quantitative blood glucose monitoring in patients with diabetes. Suitable for professional use (capillary and venous blood) and over-the-counter lay use (capillary blood only). Testing sites include fingertip, palm, forearm, upper arm, thigh, and calf.

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 (K010362)
• ACCU-CHEK Advantage system (K032552)

Submission Summary (Full Text)

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| 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<br>9115 Hague Road<br>Indianapolis, IN 46250<br>[phone] |
| | Contact Person: Scott Thiel |
| | Date Prepared: December 15, 2004 |
| 2) Device name | Proprietary name: ACCU-CHEK® Aviva System |
| | Common name: Whole blood glucose test system |
| | Classification name: 75, LFR, Glucose dehydrogenase, glucose |
| 3) Predicate device | We claim substantial equivalence to the ACCU-CHEK Advantage system, K010362 and K032552. |
| 4) Device description | The ACCU-CHEK Aviva system utilizes reagent test strips stored within a desiccated vial. A test strip is removed from the vial and inserted into the meter. Upon insertion, the meter is activated. Blood is applied to the end of the test strip, 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 small electrical current in the test strip. The meter reads the current and gives the blood glucose result. |

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K 003474

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5) Intended Use The ACCU-CHEK® Aviva 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 blood glucose in the home or health care facility. The device is indicated for professional use and over-thecounter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.

The Roche Diagnostics ACCU-CHEK Aviva system is substantially 6) Comparison to predicate equivalent to other products in commercial distribution intended for similar device use. Most notably it is substantially equivalent to the currently marketed ACCU-CHEK Advantage system.

The ACCU-CHEK Aviva system is similar to the ACCU-CHEK Advantage 7) Similarities to predicate system in the following ways: device

| Topic | Comment |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Both systems are intended for testing<br>glucose in whole blood by persons<br>with diabetes or by health care<br>professionals in the home or in<br>health care facilities. |
| Closed system | Each systems' test strips and<br>controls are designed to be used only<br>with that system. |
| Sample types | Both systems utilize whole blood<br>samples (capillary or venous). |
| Home and Professional use | Both systems are intended to be used<br>by persons in their home, or by<br>health care professionals in health<br>care facilities. |
| Test strip storage conditions | Store at room temperature, less than<br>90°F. Do not freeze. |

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:

| Topic | Comment |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Quality control procedure | Quality controls are tested when the cap is left off the vial of test strips, when a new vial is opened, if the meter is dropped, if the result does not agree with the way the user feels, whenever the user wishes to check to performance of the system. |
| Reportable range | 10 – 600 mg/dL |
| Warnings and precautions | Both systems are for in vitro diagnostic use only. |
| Monitor coding process | Both systems use a code key, included in the test strip vial, inserted into the meter. |
| Test strip packaging | Both systems provide test strips in a desiccated vial. |

7) Similarities to predicate device (continued)

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8) Differences from predicate device

The ACCU-CHEK Aviva system and the ACCU-CHEK Advantage system differ in the following ways:

| Topic | ACCU-CHEK Aviva | ACCU-CHEK<br>Advantage |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Identification of control<br>solution results | Automatically<br>distinguishes control<br>solutions from whole<br>blood samples. | User must identify<br>(flag) the control<br>solution result<br>manually. |
| Test sample volume<br>Test time | 0.6 uL<br>5 seconds | 4.0 uL<br>26 seconds (Comfort<br>Curve test strips) |
| Expiration | In addition to<br>information included in<br>labeling, the code key<br>contains expiration date<br>of associated test strips.<br>System informs user<br>when code key has<br>expired. | No notification of<br>expiration beyond that<br>included in labeling. |
| Test strip technology | The system utilizes<br>both AC/DC electrical<br>impedance information. | The system utilizes<br>electrical<br>biamperometry<br>information. |

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| Topic | ACCU-CHEK Aviva | ACCU-CHEK<br>Advantage |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling instructions<br>regarding expected<br>results | The normal fasting<br>blood glucose range for<br>an adult without<br>diabetes is 74 – 106<br>mg/dL. Two hours<br>after meals, the blood<br>glucose range for an<br>adult without diabetes<br>is less than 140 mg/dL.<br>For people with<br>diabetes: please consult<br>your doctor for the<br>blood glucose range<br>appropriate for you. | The normal fasting<br>adult blood glucose<br>range for a non-diabetic<br>is 70 – 105 mg/dL.<br>One to two hours after<br>meals, normal blood<br>glucose levels should<br>be less than 140 mg/dL.<br>Doctors will determine<br>the range that is<br>appropriate for their<br>individual patients. |

8) Differences from predicate device (continued)

#### Benefits ACCU-CHEK Aviva's new test strip technology is convenient and easy-touse. Its look, feel, and handling are similar and familiar to conventional reagent test strip users.

ACCU-CHEK Aviva's new test strip technology also allows for the addition of several new test strip fail-safes:

- The ACCU-CHEK Aviva system performs more than 150 checks on . the integrity of each test strip prior to use. Strips that have been exposed to excessive heat or humidity are not used to generate test results.
- . The ACCU-CHEK Aviva system automatically compensates for some variation in temperature and hematocrit through the AC electrical information channel.
- The ACCU-CHEK Aviva system automatically locks out the user . after the test strip expiration date has been exceeded.

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Image /page/5/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 or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

APR 2 7 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Scott Thiel Regulatory Affairs Program Principal Roche Diagnostics Corp. 9115 Hague Rd Indianapolis, IN 46260

k043474 Re: Trade/Device Name: ACCU-CHEK® Aviva System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: March 28, 2005 Received: March 29, 2005

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 logally marketed predicate device results in a classification for your device and thus, perceits 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 mobile [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Jean M. Cooper, MS, DUM

Jean 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: K043474

Device Name: ACCU-CHEK® Aviva System

Indications For Use:

The ACCU-CHEK® Aviva 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 blood glucose in the home or health care facility. The device is intended for professional use and over-the-counter sale. Professionals may use the test strip to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and S

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