ACCU-CHECK VOICEMATE

K982079 · Boehringer Mannheim Corp. · LFR · Aug 28, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982079
• Device Name: ACCU-CHECK VOICEMATE
• Applicant: Boehringer Mannheim Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Aug 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

Designed for testing glucose in whole blood by visually impaired persons with diabetes. The product will be marketed over-the-counter.

Device Story

Accu-Chek Voicemate is a portable self-monitoring blood glucose (SMBG) system for visually impaired users. It integrates an Accu-Chek Advantage meter, Comfort Curve test strips, and Softclix lancet device. A key feature is an integrated bar code reader developed with Eli Lilly to identify specific insulin vials, assisting users in distinguishing medication. The device provides blood glucose results and insulin identification via audio output. It is intended for home use by patients. The system simplifies testing by eliminating manual timing or blotting steps required by older systems; the test strip design allows tactile location of the dosing area. The device output assists patients in managing diabetes and medication safety.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and design features.

Technological Characteristics

Portable SMBG system; includes meter, test strips, and lancet device. Features integrated bar code reader for insulin vial identification. Uses Comfort Curve test strips designed for tactile dosing. Software-controlled audio output for results and vial identification. Battery-operated.

Indications for Use

Indicated for visually impaired persons with diabetes for testing glucose in 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

• Boehringer Mannheim Accu-Chek II Freedom

Submission Summary (Full Text)

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| AUG 28 1998 | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>510(k) Summary</b> | |
| 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/Boehringer Mannheim Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br><br>Contact Person: Mike Flis<br><br>Date Prepared: June 12, 1998 |
| 2) Device name | Proprietary name: Accu-Chek Voicemate<br>Common name: self-monitoring blood glucose test system<br>Classification name: glucose test system |
| 3) Predicate<br>device | Boehringer Mannheim Accu-Chek II Freedom |
| 4) Device<br>Description | The Accu-Chek Voicemate is a portable blood glucose test system. The<br>Accu-Chek Voicemate incorporates proven technologies, such as the Accu-<br>Chek® Advantage® Monitor, Accu-Chek™ Comfort Curve™ Test Strips,<br>and Accu-Chek™ Softclix® Lancet Device.<br><br>The Accu-Chek Voicemate differs from the currently available devices in that<br>it introduces a new function that will be especially helpful to the visually<br>impaired insulin-using diabetics. We have worked in partnership with Eli<br>Lilly & Company to develop a bar code reader that will reliably read bar<br>codes printed on the insulin vials distributed by Eli Lilly. The bar code reader<br>will help the visually impaired customers distinguish their insulin vials. |

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## 510(k) Summary, Continued

Designed for testing glucose in whole blood by visually impaired persons 5) Intended use with diabetes.

## 6) Comparison to predicate device

... ...

| Function | Accu-Chek Voicemate<br>(new device) | Accu-Chek II Freedom<br>(predicate device) |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications for<br>Use | Designed for testing glucose in whole<br>blood by visually impaired persons with<br>diabetes | Accu-Chek II Freedom Audio SBGM<br>System for the Visually Impaired is a<br>rechargeable, battery operated system for<br>visually impaired people with diabetes that<br>will accurately measure blood glucose levels |
| Incorporate which<br>Self-Monitoring<br>Blood Glucose<br>System | Accu-Chek Advantage Meter<br>Accu-Chek Comfort Curve Test Strips | Accu-Chek II Meter<br>Chemstrip bG Test Strips |
| Blood Collection<br>Device | None required. The test strips permit the<br>user to dose by applying a drop of blood to<br>the edge of the test strips. A "curve" is cut<br>into the test strip so that the exact location<br>of the dose is discernable through touch.<br>The patient may also touch the test strip<br>while dosing the test strip without<br>damaging the strips' reagent or<br>compromising the test result. | Accu-Drop™. The Chemstrip bG test strips<br>required the user to dose the test strips using<br>the Accu-Drop device (which guided the<br>blood sample to the test strips' reagent pad). |
| Preanalytic test strip<br>preparation | None required. Accu-Chek Comfort Curve<br>Test Strips do not require the user to time<br>any of the procedural steps, blot away<br>blood, or intervene in any manner once the<br>strip has been dosed. The test strip is<br>inserted into the meter before the blood<br>drop is applied. | The Chemstrip bG Test Strip required the<br>users to time the first step of the procedure,<br>wipe away excess blood from the strip and<br>then insert the test strip into the meter. |
| Insulin vial label<br>reader | Device is capable of reading bar codes<br>printed on specific insulin vial types. The<br>device's embedded software defines which<br>insulin vial labels may be read. | Function not available |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 28 1998

Mike Flis Regulatory Affairs Specialist Boehringer Mannheim 9115 Hague Road P.O. Box 50457 46250-0457 Indianapolis, Indiana

K982079 Re : Accu-Chek™ Voicemate™ System Regulatory Class: II Product Code: LFR Dated: June 12, 1998 Received: June 15, 1998

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 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, Druq, 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 aqainst 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 Requlations, 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 General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 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 entifiled, "Misbranding by reference bo
premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours,
Steven Litman

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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510(k) Number (if known): Device Name: Accu-Chek™ Voicemate™ System Indications for Use:

Designed for testing glucose in whole blood by visually impaired persons with diabetes.

The product will be marketed over-the-counter.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory Devices 20 510(k) Number Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)