INDUO BLOOD GLUCOSE METER

K011616 · Inverness Medical Innovations, Inc. · NBW · Jun 21, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011616
• Device Name: INDUO BLOOD GLUCOSE METER
• Applicant: Inverness Medical Innovations, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 21, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The InDuo™ Blood Glucose Meter is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The InDuo™ meter is intended for use outside the body (in vitro diagnostic use) by healthcare professionals and by diabetics at home as an aid to monitor the effectiveness of diabetes control. The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.

Device Story

InDuo Blood Glucose Meter; quantitative measurement of glucose in fresh capillary whole blood; in vitro diagnostic use. Device functions as both glucose meter and cap for InDuo Insulin Doser; units fit together as single device for user convenience. Used by healthcare professionals and patients at home. Provides glucose concentration readings to assist in diabetes management.

Clinical Evidence

Laboratory and clinical studies demonstrate equivalent performance to the ONE TOUCH® Ultra™ Blood Glucose Meter.

Technological Characteristics

Same technological characteristics as the legally marketed predicate device (K002134).

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood for healthcare professionals and diabetics at home to monitor diabetes control effectiveness.

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

• ONE TOUCH® Ultra™ Blood Glucose Meter (K002134)

Submission Summary (Full Text)

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# JUN 2 1 2001

K011616

### 7.0 510(k) Summary

### 510(k) Summary

(As required by 21 C.F.R. § 807.92)

| Submitted By: | Inverness Medical Technology, Inc.<br>51 Sawyer Road<br>Suite 200<br>Waltham, MA 02453-3448<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Carol A. Adiletto, M.S.<br>Director of Clinical and Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Summary Prepared: | May 24, 2001 |
| Device Name: | InDuo™ Blood Glucose Meter |
| Classification Name: | The InDuo™ Blood Glucose Meter is a Class II Device for home use, as per<br>21 CFR § 862.1345. |
| Substantial Equivalence: | The InDuo™ Blood Glucose Meter is substantially equivalent to the<br>previously cleared predicate device (K002134). |
| Description of Changes: | The changes made to the meter were done under design controls, and<br>include ergonomic changes to allow for inclusion of the InDuo™ Insulin<br>Doser to form a single unit for user convenience. |
| Statement of Intended Use: | The InDuo™ Blood Glucose Meter is intended to be used for the<br>quantitative measurement of glucose in fresh capillary whole blood. The<br>InDuo™ meter is intended for use outside the body ( <i>in vitro</i> diagnostic use)<br>by healthcare professionals and by diabetics at home as an aid to monitor<br>the effectiveness of diabetes control. |
| | The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™<br>Insulin Doser. The two devices fit together to form a single unit for user<br>convenience. |
| Technological<br>Characteristics: | The modified device has the same technological characteristics as the<br>legally marketed predicate. |
| Summary of Performance<br>Data: | Laboratory and clinical studies demonstrate that the InDuo™ Blood Glucose<br>Meter provides equivalent performance to the ONE TOUCH® Ultra™<br>Blood Glucose Meter. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 wavy lines extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 1 2001

Ms. Carol A. Adiletto, M.S. Director of Clinical and Regulatory Affairs Inverness Medical Technology, Inc. 51 Sawyer Road - Suite 200 Waltham, MA 02453

510(k) Number: K011616 Re: Trade/Device Name: LifeScan InDuo™ Blood Glucose Meter Regulation Number: 862.1345, 880.5860 Regulatory Class: II Product Code: NBW, CGA, FMF Dated: May 24, 2001 Received: May 25, 2001

Dear Ms. Adiletto:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to 1 coord 1 ood, Drag, and sions of the Act. The general controls provisions of the Act include the general of 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remancer ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such periodio GMP insposited on one with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I Dri may packet 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 any obligation you imganian Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to ocgin mansaling , quivalence of your device to a legally marketed notification. The FDA inding of succeantal requence and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your do to revices), please contact the Office of Compliance at additionally 609.10 for in True diagnestions on the promotion and advertising of your device, [phone]. Additionally, for questions of Compliance at [phone]. Also, please of Complex prease conact the Office or Compilance en premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnes and use and more [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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# 3.0 ODE Indications for Use Statement

## Indications for Use Statement

LifeScan InDuo™ Blood Glucose Meter Device Name:

#### Indications for Use:

The InDuo™ Blood Glucose Meter is intended to be used for the quantitative The InDuo Blood Gracose Meter is intenate is blood. The InDuo" Blood Glucose measurent of gracose in noon capinary (in vitro diagnostic use) by healthcare Meter is intended for use outside the body (in This Chapter in and to monitor the effectiveness of diabetes control.

The InDuo™ Blood Glucose Meter also functions as the InDuo™ Insulin Doser.
The InDuo™ Blood Columnit Same as sensessiones The two devices fit together to form a single unit for user convenience.

Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
10(k) Number K 011616

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use