MODIFICATION TO ACCU-CHEK INFORM METER

K012210 · Roche Diagnostics Corp. · NBW · Aug 9, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012210
• Device Name: MODIFICATION TO ACCU-CHEK INFORM METER
• Applicant: Roche Diagnostics Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 9, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Accu-Chek Inform Meter is designed to quantitatively measure the concentration of glucose in whole blood samples. The device is indicated for use by health care professionals and persons with diabetes mellitus. The Accu-Chek Inform Meter is an addition to the Accu-Chek brand of blood glucose monitors that incorporates the fundamental scientific technology currently found in the Accu-Chek Advantage Meter and Accu-Chek Complete Meter. The Accu-Chek Inform Meter is designed for use in conjunction with either the Accu-Chek Advantage or Accu-Chek Comfort Curve test strips.

Device Story

Accu-Chek Inform Meter is a blood glucose monitor; modification of Accu-Chek Advantage Meter. Integrates off-the-shelf PDA into meter body to incorporate AccuData GTS data gathering features. Operates by applying controlled voltage between two electrodes on test strip; glucose dehydrogenase reaction creates reduced mediator; reconversion to oxidized mediator generates current; meter software converts current to glucose value. Used by healthcare professionals and patients with diabetes. Calibration via code key inserted into meter. Output is quantitative blood glucose concentration. Facilitates data management for glucose, control, linearity, and proficiency testing results.

Clinical Evidence

Bench testing only. Analytical performance and method comparison results are derived from testing with Accu-Chek Advantage and Accu-Chek Comfort Curve test strips. The meter model does not significantly affect analytical performance or method comparison results.

Technological Characteristics

Electrochemical glucose measurement using glucose dehydrogenase reaction. System includes meter and test strips. Features integrated off-the-shelf PDA for data management. Calibration via code key. Connectivity includes data gathering features for glucose, control, linearity, and proficiency testing results.

Indications for Use

Indicated for quantitative measurement of glucose in whole blood samples for health care professionals and persons with diabetes mellitus.

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 Meter (K012210)

Reference Devices

• Accu-Chek Complete Meter

Submission Summary (Full Text)

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K012210

# AUG - 9 2001

.

| <b>Special 510(k) Summary</b> |
|-------------------------------|
|-------------------------------|

| <b>Introduction</b> | 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. |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>1) Submitter name, address, contact</b> | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Mike Flis |
| | Date Prepared: July 13, 2001 |
| <b>2) Device name</b> | Proprietary name: Accu-Chek™ Inform ^® Meter<br>Common name: whole blood glucose test system<br>Classification name: Glucose dehydrogenase, glucose |
| <b>3) Predicate device</b> | We claim substantial equivalence to the Roche Diagnostics Accu-Chek Advantage Meter. |

Continued on next page:

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### Special 510(k) Summary, Continued

The Accu-Chek Inform system is addition to the Accu-Chek brand of blood 4) Device glucose monitors that incorporates the fundamental scientific technology Description currently found in the Accu-Chek Advantage Meter. The Accu-Chek Inform Meter is a modification to the Accu-Chek Advantage Meter that involves integrating the AccuData GTS unit's data gathering features into the meter. The modification does not affect the device's intended use. The Accu-Chek Inform Meter may be used in conjunction with the same test strips indicated for use with the Accu-Chek Advantage Meter, and the test principle described on the following page is not affected by the design modifications. This modification can be accomplished due in part to the availability of palmtype computers (PDA). Our product designers modified the Accu-Chek Advantage Meter by building into its body an off-the-shelf PDA. The PDA module enabled our designers to integrate the AccuData GTS unit's data gathering features into the meter itself. The Accu-Chek Inform Meter was designed to be convenient and easy to use. The Accu-Chek Inform Meter is designed to quantitatively measure the 5) Intended use

concentration of glucose in whole blood samples. The device is indicated for use by health care professionals and persons with diabetes mellitus.

Continued on next page

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## Special 510(k) Summary, Continued

6) Comparison to predicate device

The Roche Diagnostics Accu-Chek Inform Meter is substantially equivalent to the Accu-Chek Advantage Meter, as the following table shows.

| | Accu-Chek Advantage Meter<br>(predicate device) | Accu-Chek<br>Inform Meter |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended use | The meter is designed to quantitatively measure the<br>concentration of glucose in a whole blood sample. | No change |
| Indications for use | The device is indicated for professional use and over-the-<br>counter sale. | No change |
| Fundamental<br>scientific<br>technology | The measurement is accomplished by applying a controlled<br>voltage between two identical electrodes embedded within<br>the test strip, which causes the reduced mediator formed<br>during the glucose dehydrogenase reaction to be reconverted<br>to an oxidized mediator. This generates a small current that<br>is measured by the meter. The meter's software converts this<br>electrical currency signal into a blood glucose value. The<br>system's correlation to a comparative laboratory method is<br>established by the manufacturer; each test strip vial is<br>packaged with a calibration code key that the user insets into<br>the meter to ensure an appropriate calibration. | No change |
| OTC User's<br>Manual | Professional and lay person instructions included within one<br>manual. | Professional and lay<br>person instructions<br>provided in separate<br>manuals. |
| Analytical<br>performance<br>claims | Derived from testing with the two test strips listed above.<br>Claims are stated in test strip package inserts. Meter model<br>does not significantly affect analytical performance claims. | No change |
| Performance<br>comparisons | Derived from testing with the two test strips listed above.<br>Claims are stated in test strip package inserts. Meter model<br>does not significantly affect method comparison results. | No change |
| Data management | Home use – blood glucose and liquid control testing results<br>Health care provider (w/AccuData GTS) -- blood glucose,<br>liquid control, linearity, and proficiency testing results and<br>operator and patient identification | No change |
| Technical Service | Accu-Chek Customer Care Center available to respond to<br>customer questions via a toll-free telephone service around-<br>the-clock, every day of the year. | No change |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 9 2001

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

510(k) Number: K012210 Re: Trade/Device Name: Accu-Chek™ Inform® Meter Regulation Number: 862.1345 Regulatory Class: II. Product Code: NBW, LFR Dated: July 13, 2001 Received: July 16, 2001

Dear Mr. Flis:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your wined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersate conmisers price to hat 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 I cacal I ood, Drag, and Goomist be Act. The general controls provisions of the Act include the general of the is provention, 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 ( remainer ripps of a love found in the Code of Federal Regulations, Title 21, Parts 800 to 895. arroomig your as not con can t determination assumes compliance with the Good Manufacturing 11 Substantally Vequiral (GMP) regulation (21 CFR Part 820) and that, through r ractions, GMP inspections, the Food and Drug Administration (FDA) will verify such perfoure offic inspections of the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, Please note: this response to your premarket notification submission does not affect register. Freason you might have under sections 531 through 542 of the Act for devices under the any obligation you anglation Control provisions, or other Federal laws or regulations.

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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 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/cdrh/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

Special 510(k) Number (if known): Kolaa10 Device Name: Accu-Chek™ Inform® Meter

Indications for Use:

The Accu-Chek Inform Meter is designed to quantitatively measure the concentration of glucose in whole blood samples. The device is indicated for use by health care professionals and persons with diabetes mellitus.

The Accu-Chek Inform Meter is an addition to the Accu-Chek brand of blood glucose monitors that incorporates the fundamental scientific technology currently found in the Accu-Chek Advantage Meter and Accu-Chek Complete Meter. The Accu-Chek Inform Meter is designed for use in conjunction with either the Accu-Chek Advantage or Accu-Chek Comfort Curve test strips.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012210
Cooper

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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