ACCU-CHEK SIMPLICITY SYSTEM

K993829 · Roche Diagnostics Corp. · LFR · Dec 9, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993829
• Device Name: ACCU-CHEK SIMPLICITY SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Dec 9, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The test strips are to be used with the Accu-Chek Simplicity meter. The Accu-Chek Simplicity system is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.

Device Story

Accu-Chek Simplicity System is a whole blood glucose monitoring system. It utilizes test strips and a meter to measure glucose levels. Input is a 3 µL fresh capillary whole blood sample applied to a test strip. The system uses a glucose deoxy reductase reagent chemical reaction; the meter detects photometric changes to quantify glucose concentration. The device is intended for use by patients with diabetes or healthcare professionals in home or clinical settings. Results are displayed on the meter, allowing users to monitor blood glucose levels and manage diabetes. The system includes a code chip for strip calibration. It provides results equivalent to plasma lab methods.

Clinical Evidence

Clinical evidence includes method comparison studies and precision testing. Capillary blood study (N=297) showed y=1.02x-5.2, r=0.977. Consumer study (N=230) showed y=1.05x-7.0, r=0.982. Precision testing (N=20/level) demonstrated SDs ranging from 1.6 to 16.3 mg/dL and CVs between 2.8% and 4.1% across various control and venous blood levels. Testing confirmed performance at altitudes up to 10,150 feet.

Technological Characteristics

Photometric measurement of glucose deoxy reductase chemical reaction. Reagents include glucose-dye-oxidoreductase, bis-(2-hydroxyethyl)-(4-hydroxminocyclohexa-2,5-dienylidene)-ammonium chloride, and 2,18-phosphomolybdic acid. Requires code chip for calibration. Operates at 50-104°F and <85% humidity. Reportable range 10-600 mg/dL. Hematocrit range 30-57%.

Indications for Use

Indicated for glucose testing in whole blood for persons with diabetes or by healthcare professionals in home or clinical settings.

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 Simplicity System (K973629)

Submission Summary (Full Text)

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DEC - 9 1999

# 510(k) Summary

| 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 Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] |
| | Contact Person: Mike Flis |
| | Date Prepared: November 09, 1999 |
| 2) Device name | Proprietary name: Accu-Chek Simplicity™ System<br>Common name: whole blood glucose test system<br>Classification name: Glucose dehydrogenase, glucose |
| 3) Predicate<br>device | We claim substantial equivalence to the current legally marketed version of<br>the same device. |
| 4) Device<br>Description | Instrument Operating Principle -- photometric<br>Reagent Test Principle -- glucose deoxy reductase |
| 5) Intended use | The test strips are to be used with the Accu-Chek Simplicity meter. The<br>Accu-Chek Simplicity system is designed for testing glucose in whole blood<br>by persons with diabetes or by health care professionals in the home or in<br>health care facilities. |
| 6) Comparison<br>to predicate<br>device | The Roche Diagnostics Accu-Chek Simplicity System is substantially<br>equivalent to the current legally marketed version of the same device. |

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### Comparison to Predicate Device - .

### Similarities

| Feature/Claim | Detail |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The test strips are to be used with the Accu-Chek Simplicity meter.<br>The Accu-Chek Simplicity system is designed for testing glucose<br>in whole blood by persons with diabetes or by health care<br>professionals in the home or in health care facilities. |
| Test principle | Glucose dehydrogenase chemical reaction. The instrument<br>measures the chemical reaction by detecting photometric changes. |
| Monitor coding<br>procedure | Code chip is provided with each carton of test strips. |
| Minimum sample<br>volume | 3 µL |
| Test strip storage<br>conditions | Store the strips at room temperature between +36° F and +86° F.<br>Do not freeze. |
| Test strip operating<br>conditions | Use at temperatures between 50° and 104° F and less than 85%<br>humidity. |
| Quality control<br>procedure | Tests should be run with liquid quality control materials whenever<br>a new vial of test strips is opened or an unusual blood test result is<br>obtained. |
| Labeling instructions<br>regarding expected<br>results | The normal fasting adult blood glucose range for a non-diabetic is<br>70-105 mg/dL. One to two hours after meals, normal blood<br>glucose levels should be less than 140 mg/dL. Doctors will<br>determine the range that is appropriate for the patients. |
| Labeling instructions<br>regarding response to<br>unusual results | Run a quality control test, if the result is outside the acceptable QC<br>recovery range contact Roche Diagnostics's Accu-Chek Customer<br>Care center; if result is within the acceptable range, review proper<br>testing procedure and repeat blood glucose test with a new test<br>strip. |
| Hematocrit range | 30 to 57% |
| Reportable range | 10-600 mg/dL |
| Warnings and<br>precautions | For in vitro diagnostic use only. |
| Reagent stability | 18 months |

Continued on next page

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## Comparison to Predicate Device, Continued

#### Similarities, Contd.

| Reagent composition | Copied from test strip carton label (qty/cm2): | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Glucose-dye-oxidoreductase<br>Bis-(2-hydroxyethyl)-(4-hydroxminocyclohexa-2,5-dienylidene)-<br>ammonium chloride<br>2,18-Phosphomolybdic acid<br>Stabilizer<br>Nonreactive substances. | |
| | Minimum at time of manufacture. | |

#### Differences

| Feature | Accu-Chek Simplicity<br>Test Strip<br>(modified) | Accu-Chek Simplicity<br>Test Strip<br>(predicate) |
|-------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------|
| Values equivalent to... | plasma lab method | whole blood method |
| Maximum altitude | Tested acceptably at<br>elevations up to 10,150<br>feet above sea level1 | Tested acceptably at<br>elevations up to 9500<br>feet above sea level. |
| Acceptable sample type | Fresh capillary whole<br>blood only2 | Fresh capillary and<br>heparinized venous<br>whole blood samples |

- 1. The effect of altitude was examined at a different clinical investigation site than K971876. The site selected for the most recent examination was higher than the prior site. The results of the 1999 study confirm the device performs acceptably at 10,150 feet.
- 2. The proposed modification does not adversely effect the product's performance with heparinized whole blood samples. The removal of the venous sample claim from the product's labeling is triggered by our desire to position this device as a test best suited for consumer testing. The draft labeling only includes references to capillary fingerstick testing procedures and summaries of results obtained in capillary blood clinical studies.

Continued on next page

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# Comparison to Predicate Device, Continued

Performance Characteristics Method Comparison

| Feature | Accu-Chek Simplicity<br>Test Strip Package<br>Insert<br>(modified) | Accu-Chek Simplicity<br>Test Strip Package<br>Insert<br>(predicate) |
|------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Laboratory method | Hitachi glucose plasma | Hitachi glucose hexokinase<br>whole blood |
| Capillary blood study | N = 297<br>$y = 1.02x - 5.2$<br>$r = 0.977$<br>$range = 57 to 515 mg/dL$ | N = 202<br>$y = 1.02x + 2.6$<br>$r = 0.989$<br>$range = 51 to 490 mg/dL$ |
| Physician's Office<br>Venous blood study | Not applicable | N = 104<br>$y = 1.029x + 2.7$<br>$r = 0.995$<br>$range = 35 to 483 mg/dL$ |
| Consumer study | N = 230<br>$y = 1.05x - 7.0$<br>$r = 0.982$<br>$range = 57 to 515 mg/dL$ | N = 134<br>$y = 1.082x - 2.9$<br>$r = 0.976$<br>$range = 58 to 357 mg/dL$ |

Continued on next page ﭘﺎ

r

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# Comparison to Predicate Device, Continued

Performance Characteristics,
Contd.

Precision

| Parameter | Accu-Chek<br>Simplicity<br>Test Strip<br>Package Insert<br>(modified) | Accu-Chek<br>Simplicity<br>Test Strip Package<br>Insert<br>(predicate) |
|----------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------|
| | N = 20/Level | N = 20/Level |
| Control Level 1 | | |
| •Mean (mg/dL) | 52 | 84.0 |
| •Standard Deviation (SD) (mg/dL) | 1.6 | 2.0 |
| Control Level 2 | | |
| •Mean (mg/dL) | 167 | 196.4 |
| •Standard Deviation (SD) (mg/dL) | 4.7 | |
| •CV | 2.8 | 2.5 |
| Venous Blood Level 1 | | |
| •Mean (mg/dL) | 53 | 28.7 |
| •Standard Deviation (SD) (mg/dL) | 1.7 | 1.2 |
| Venous Blood Level 2 | | |
| •Mean (mg/dL) | 153 | 129.4 |
| •Standard Deviation (SD) (mg/dL) | 6.3 | |
| •CV | 4.1 | 3.0 |
| Venous Blood Level 3 | | |
| •Mean (mg/dL) | 499 | 335.0 |
| •Standard Deviation (SD) (mg/dL) | 16.3 | |
| •CV | 3.3 | 3.4 |

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Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 9 1999

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

Re: K993829

> Trade Name: Accu-Chek Simplicity™ System Regulatory Class: II Product Code: LFR Dated: November 10, 1999 Received: November 12, 1999

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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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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#### Page 2

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 entitled, "Misbranding by reference to 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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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 Simplicity™ System

Indications for Use:

The test strips are to be used with the Accu-Chek Simplicity meter. The Accu-Chek Simplicity system is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973629

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)