ACCU-CHEK ACTIVE TEST SYSTEM

K012324 · Roche Diagnostics Corp. · NBW · Dec 5, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012324
• Device Name: ACCU-CHEK ACTIVE TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

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 Test System is a blood glucose monitoring system comprising a handheld meter, lancet device, and lancets. Used by professionals and patients (OTC) for capillary whole blood glucose measurement. System requires test strips and liquid controls. Device provides quantitative glucose concentration readings to assist in diabetes management. Underdosing detection feature included. AST (Alternate Site Testing) capability allows testing on the forearm.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics and performance specifications against legally marketed predicate devices.

Technological Characteristics

Handheld glucose meter; uses capillary whole blood samples; requires 1 µL sample volume; supports alternate site testing (AST) on the forearm; includes underdosing detection; glucose dehydrogenase-based measurement principle.

Indications for Use

Indicated for professional and over-the-counter use for the quantitative measurement of glucose concentration in capillary whole 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 Active (K011738)
• Lifescan/Inverness One Touch Ultra Test System (K002134)
• Abbott/Medisense Sof-Tact Test System (K001993)
• Therasense Freestyle Test System (K992684)
• Lifescan/Inverness FastTake Test System (K001427)

Reference Devices

• Amira AtLast (K982076)
• Therasense Freestyle (K000582)

Submission Summary (Full Text)

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K012324

## Accu-Chek Active Test System

| DEC 0 5 2001 | 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<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: July 20, 2001 |
| 2) Device name | Proprietary name: Accu-Chek Active Test System<br>Common name: Blood glucose test system<br>Classification name: glucose dehydrogenase, glucose |
| 3) Predicate<br>device | The Roche Diagnostics Accu-Chek Active Test System is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the recently cleared version of the same product. In addition, the AST claim described in this 510(k) premarket notification is substantially equivalent to claims cleared for the following medical devices. <ul><li>Lifescan/Inverness One Touch Ultra Test System (K002134-Special)</li><li>Abbott/Medisense Sof-Tact Test System (K001993-Traditional)</li><li>Therasense Freestyle Test System (K992684-Traditional)</li><li>Lifescan/Inverness FastTake Test System (K001427-Special)</li></ul> |
| 4) Device<br>Description | The Accu-Chek Active Test System includes a handheld meter, lancet device, lancets, and instructions for use. Test strips and liquid controls may be acquired separately. |
| | Continued on next page |

.

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## 510(k) Summary, Continued

·

| 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. |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Comparison<br>to predicate<br>device | The Accu-Chek Active Test System is substantially equivalent to other<br>products in commercial distribution intended for similar use. |

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omparison to Predicate Devices

| Accu-Chek<br>Active with AST | Accu-Chek<br>Active | Amira<br>AtLast | Therasense<br>Freestyle | Medisense<br>Sof-Tact | Lifescan One<br>Touch Ultra | Lifescan<br>FastTake | |
|-------------------------------------------|--------------------------------------|--------------------------------------|--------------------------------------|-------------------------------------------|---------------------------------------|------------------------------------------|------------------------------------------|
| 510(k)<br>(T) = Trad.<br>(S) = Special | K011738 (S) | K982076 (T) | K992684 (T)<br>& K000582 (S) | K001993 (T) | K002134 (S) | K001427 (S) | |
| 510(k) Sponsor<br>Intended Use | Roche<br>Blood glucose<br>monitoring | Roche<br>Blood glucose<br>monitoring | Amira<br>Blood glucose<br>monitoring | Therasense<br>Blood glucose<br>monitoring | Abbott<br>Blood glucose<br>monitoring | Inverness<br>Blood glucose<br>monitoring | Inverness<br>Blood glucose<br>monitoring |
| OTC sale | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Minimum sample<br>volume required<br>(µL) | 1 | 1 | 2 | 0.3 | 3 | 1 | 1.5 |
| Fingertip | Yes | Yes | No | Yes | Yes | Yes | Yes |
| AST | Yes | No | Yes | Yes | Yes | Yes | Yes |
| AST limited to<br>forearm only | Yes | NA | No | No | No | Yes | Yes |
| Underdosing<br>detection | Yes | Yes | Yes | Yes | No | No | Yes |

21

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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 curved lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

DEC 0 5 2001

Re: k012324

> Trade/Device Name: Accu-Chek Active Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: November 8, 2001 Received: November 13, 2001

Dear Mr. Flis:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 predicate device 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 1 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, please 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 International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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): 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) | |
|----------------------------------------------------------------|---------|
| | |
| (Division Sign-Off)<br>Division of Clinical Laboratory Devices | |
| 510(k) Number | K012324 |

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)