ACCU-CHEK PERFORMA SYSTEM

K070585 · Roche Diagnostics Corp. · NBW · May 25, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070585
• Device Name: ACCU-CHEK PERFORMA SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ACCU-CHEK Performa 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.

Device Story

System measures glucose concentration in whole blood; utilizes GDH-PQQ enzyme and amperometric test strips. User applies blood sample to strip; meter applies voltage; generates current proportional to glucose concentration. Used in home or clinical settings; operated by patients or healthcare professionals. Provides quantitative glucose result on display; aids in diabetes management and glycemic monitoring. System includes meter, test strips with code key, and lancing device.

Clinical Evidence

Bench testing only. Performance testing demonstrated that the device meets all predetermined acceptance criteria for its intended use.

Technological Characteristics

Glucose dehydrogenase-based electrochemical test system. Components: blood glucose monitor, test strips, control solutions. Measures electric current proportional to glucose concentration. Class II device (21 CFR 862.1345).

Indications for Use

Indicated for quantitative glucose monitoring in patients with diabetes or those requiring glucose testing. Suitable for home use (capillary blood) and professional use (capillary, venous, arterial, and neonatal blood).

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

Submission Summary (Full Text)

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K070585

| 510(k) Summary | MAY 2 5 2007 |
|----------------|--------------|
|----------------|--------------|

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: February 27, 2007 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: ACCU-CHEK Performa System<br>Classification name: Glucose dehydrogenase, glucose test system<br>(21 C.F.R. § 862.1345)(75LFR) |
| 3) Predicate device | ACCU-CHEK Aviva System |
| 4) Device Description | The ACCU-CHEK Performa is a blood glucose testing product and based on the ACCU-CHEK Aviva System. The ACCU-CHEK Performa system maintains performance characteristics with ACCU-CHEK Aviva.<br>The ACCU-CHEK Performa system is comprised of:<br><ul><li>The ACCU-CHEK Performa blood glucose monitor</li><li>The ACCU-CHEK Performa blood glucose test strip</li><li>The ACCU-CHEK Performa Control Solutions</li></ul> |

The test principle is:
Blood from the test site works with the chemicals in the test strip to make
a small electric current in the test strip. The meter reads the current and
gives a blood glucose result.
Continued on next page

510(k) Summary

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## 510(k) Summary, Continued

| 5) Intended<br>use | The ACCU-CHEK Performa system is designed to quantitatively measure<br>the concentration of glucose for monitoring glucose in the home or in<br>health care facilities. Testing sites include traditional fingertip site along<br>with palm, forearm, upper arm, thigh, and calf.<br>Professionals may use the test strips to test capillary, venous, arterial, and<br>neonatal blood; home use is limited to capillary whole blood testing. |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Substantial<br>equivalence | The Roche Diagnostics ACCU-CHEK Performa System is substantially<br>equivalent to the current legally marketed ACCU-CHEK Aviva System. |
| 7) Data<br>demonstrating<br>substantial<br>equivalence | Performance testing on the ACCU-CHEK Performa System demonstrated<br>that the device meets the performance requirements for its intended use.<br>All predetermined acceptance criteria were satisfied. The data<br>demonstrates that the ACCU-CHEK Performa is substantially equivalent to<br>the predicate device. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 2 5 2007

Mr. Scott Thiel, MBA, MT(ASCP) Regulatory Affairs Program Manager Regulatory Affairs Diabetes Care Indianapolis Office Roche Diagnostic Corp. 9115 Hague Rd. Indianapolis, IN 46256

k070585 Re:

Trade/Device Name: ACCU-CHEK® Performa System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR Dated: February 27, 2007 Received: March 1, 2007

Dear Mr. Thiel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your becamined the device is substantially equivalent (for the indications forcronous above and normal to legally marketed predicate devices marketed in interstate for use build in the energency of 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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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k070585 Attachment 3

## Indications for Use

K070585 510(k) Number (if known):

ACCU-CHEK® Performa System Device Name:

Indications For Use:

The ACCU-CHEK® Performa system is designed to quantitatively measure the concentration of The recor crimites I visual 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 XX (Part 21 CFR 801 Subpart D)

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Over-The-Counter Use ___ XX (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)

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K070585