ACCU-CHEK COMPACT TEST STRIP

K031755 · Roche Diagnostics Corp. · LFR · Jul 3, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031755
• Device Name: ACCU-CHEK COMPACT TEST STRIP
• Applicant: Roche Diagnostics Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Jul 3, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact Meter. The Accu-Chek Compact system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale. The Accu-Chek Compact system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.

Device Story

Accu-Chek Compact System measures glucose concentration in capillary and venous whole blood. System consists of meter and test drums. Principle of operation: reflectance photometry using glucose-dye-oxidoreductase enzyme. Blood sample applied to test strip; glucose oxidized to glucolactone; reduction equivalents transferred to PQQ; mediator reduced; indicator 2,18-phosphomolybdic acid reduced to produce color (heteropolyblue). Meter reads color intensity to determine glucose concentration. Used in clinical settings by professionals and at home by patients. Barcode on drum provides coding information to meter. Output displayed to user for glucose monitoring. Benefits include rapid, quantitative blood glucose assessment for diabetes management.

Clinical Evidence

Multi-center performance study conducted with N=120 samples. Accuracy compared to laboratory plasma glucose reference: Y=0.99x-1.96, correlation coefficient 0.983, range 56-531 mg/dL. Consumer study (N=120) showed Y=1.05x-5.065, correlation coefficient 0.983. Precision testing performed on aqueous and blood samples at low, mid, and high concentrations; all results met predetermined acceptance criteria.

Technological Characteristics

Reflectance-based glucose test system. Reagent: PQQ-dependent glucose-dye-oxidoreductase, bis-(2-hydroxyethyl)-(4-hydroximinocyclohexa-2,5-dienylidene)-ammonium chloride, and 2,18-phosphomolybdic acid. Reportable range: 10-600 mg/dL. Hematocrit range: 20-65%. Operating temperature: 50°F to 104°F. Coding via drum barcode. Reagent stability: 18 months.

Indications for Use

Indicated for professional and lay person use to quantitatively measure glucose in capillary and venous whole blood. Lay users may test using capillary blood from fingertips, forearm, upper arm, thigh, calf, and palm.

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 Compact Test Strip (K031755)

Submission Summary (Full Text)

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# 510(k) Summary

K031755
JUL 03 2003

| 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]<br>Contact Person: Scott Thiel<br>Date Prepared: June 3, 2003, 2003 |
| 2) Device name | Proprietary name: Accu-Chek Compact System<br>Classification name: Glucose dehydrogenase, glucose test system<br>(21 C.F.R. § 862.1345)(75LFR) |
| 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 -- reflectance<br>Reagent Test Principle -- glucose dehydrogenase |
| 5) Intended use | The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact<br>Meter. The Accu-Chek Compact system is designed to quantitatively<br>measure the concentration of glucose in capillary and venous whole blood.<br>The device is indicated for professional use and over-the-counter sale. The<br>Accu-Chek Compact system is indicated for lay person use with capillary<br>whole blood samples drawn from the fingertips, forearm, upper arm, thigh,<br>calf, and palm. |

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The Roche Diagnostics Accu-Chek Compact Test Strip is substantially 6) Similarities equivalent to the current legally marketed version of the same device. The proposed modification is relatively modest in scope. The following is a list of some of the claims and features unaffected by the proposed modification.

| Feature/Claim | Detail |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Accu-Chek Compact Test Drums are used with the Accu-Chek<br>Compact Meter. The Accu-Chek Compact system is designed to<br>quantitatively measure the concentration of glucose in capillary and<br>venous whole blood. The device is indicated for professional use and<br>over-the-counter sale. The Accu-Chek Compact system is indicated for<br>lay person use with capillary whole blood samples drawn from the<br>fingertips, forearm, upper arm, thigh, calf, and palm. |
| Test principle | Step 1: Glucose from the whole blood sample is oxidized by the PQQ-<br>dependent enzyme glucose-dye-oxidoreductase to glucolactone and the<br>reduction equivalents are transferred to the enzyme bound PQQ to give PQQH2.<br>Step 2: The enzyme transfers the reduction equivalents from PQQH2 to the<br>oxidized form of the mediator bis-(2-hydroxyethyl)-(4-hydroximinocyclohexa-<br>2,5-dienylidene)-ammonium chloride.<br>Step 3: The reduced form of the mediator reduces the indicator 2,18-<br>phosphomolybdic acid to produce the color heteropolyblue. |
| Monitor | Designed for use with the currently distributed version of the Accu-Chek<br>Compact meter. |
| Monitor coding<br>procedure | Barcode containing coding information is printed on each drum of test<br>strips. |
| Test strip storage<br>conditions | Store at room temperature between +36° F (+2° C) and +86° F (+30° C). |
| Test strip operating<br>conditions | Between +50° F (+10° C) and +104° F (+40° C). |
| Quality control<br>testing frequency | Tests should be run with liquid quality control materials whenever a new<br>vial of test strips is opened or an unusual blood test result is obtained. |
| Quality control<br>acceptable range | The mean is strip lot specific and will be determined individually. The<br>range of the controls is within ± 15 mg/dL or ± 15% compared to the<br>determined mean. |

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#### 6) Similarities (continued)

| Feature/Claim | Detail |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling<br>instructions<br>regarding expected<br>results | The normal fasting adult blood glucose range for a non-diabetic is 70-105 mg/dL. One to two hours after meals, normal blood glucose levels should<br>be less than 140 mg/dL. Doctors will determine the range that is<br>appropriate for the patients. |
| Labeling<br>instructions<br>regarding response<br>to 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 Care<br>center; if result is within the acceptable range, review proper testing<br>procedure and repeat blood glucose test with a new test strip. |
| Reagent stability | 18 months |
| Reportable range | 10-600 mg/dL |
| Hematocrit | 20 - 65 % |
| Acceptable sample<br>types | Professional Testing<br>Capillary whole blood samples (fingertip or alternative sites)<br>Venous whole blood samples<br><br>Lay User Testing<br>Capillary whole blood samples (fingertip or alternative sites) |
| Warnings and<br>precautions | For in vitro diagnostic use only. |
| Reagent<br>composition | Glucose-dye-oxidoreductase * Bis-(2-hydroxyethyl)-(4-hydroximinocyclohexa-2,5-dienylidene)-ammonium chloride 2,18-phosphomolybdic acid Stabilizer Non-reactive ingredients *(from A. Calcoaceticus, recombinant from E. Coli) |

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### Differences

| Feature | Accu-Chek Compact Test Strip<br>(modified) | Accu-Chek Compact Test Strip<br>(predicate) |
|------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Test time | 8 seconds | 15 seconds |
| Minimum sample<br>volume | 1.5 uL | 3.5 uL |
| Interference from<br>triglycerides | > 5000 mg/dL | > 1000 mg/dL |
| Bilirubin | None | > 20 mg/dL |
| Fluoride | Listed as interfering preservative in<br>specimen collection section. | Listed as interfering preservative in<br>specimen collection and limitations<br>sections. |
| Accuracy | N = 120<br>Y=0.99x-1.96<br>Correlation coefficient = 0.983<br>Range = 56 - 531 mg/dL | N = 138<br>Y=0.954x+1.8<br>Correlation coefficient = 0.992<br>Range = 64 - 350 mg/dL |
| Consumer Studies | N = 120<br>Y=1.05x-5.065<br>Correlation coefficient = 0.983<br>Range = 56 - 531 mg/dL | N = 138<br>Y=0.956x+2.0<br>Correlation coefficient = 0.994<br>Range = 63 - 359 mg/dL |
| Precision, aqueous,<br>low | N = 10<br>Mean = 43.2 mg/dL<br>SD = 1.0 | N = 10<br>Mean = 58.0 mg/dL<br>SD = 1.0 |
| Precision, aqueous,<br>mid | None claimed | N = 10<br>Mean = 127.3 mg/dL<br>%CV = 2.7 |
| Precision, aqueous,<br>high | N = 10<br>Mean = 339 mg/dL<br>%CV = 1.5 | N = 10<br>Mean = 227.7<br>%CV = 2.4 |
| Precision, blood,<br>low | N = 10<br>Mean = 36 mg/dL<br>SD = 1.0 | N = 20<br>Mean = 56 mg/dL<br>SD = 1.4 |
| Precision, blood,<br>mid | N = 10<br>Mean = 165 mg/dL<br>%CV = 1.4 | N = 20<br>Mean = 140 mg/dL<br>%CV = 1.9 |
| Precision, blood,<br>high | N = 10<br>Mean = 300 mg/dL<br>%CV = 1.5 | N = 20<br>Mean = 390 mg/dL<br>%CV = 3.0 |

:

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7) Data demonstrating substantial equivalence

Performance testing on the modified Accu-Chek Compact Test Strip demonstrated that the device meets the performance requirements for its intended use. A multi-center performance study was conducted to evaluate the accuracy and precision of the modified device. The clinical data demonstrates that the performance of the Accu-Chek Compact Test Strip correlates well with the laboratory plasma glucose reference test methodology. All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Compact Test Strip is substantially equivalent to the predicate device.

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Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Scott Thiel Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

JUL 0 3 2003

Re: k031755

> Trade/Device Name: Accu-Chek Compact Test Strip Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: LFR Dated: June 3, 2003 Received: June 6, 2003

Dear Mr. Thiel:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

510(k) Number (if known): K03 1755 "Special
Device Name: Accu-Chek Compact Test Strip

Indications for Use:

The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact Meter. The Accu-Chek Compact system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-thecounter sale. The Accu-Chek Compact system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division Sign-Off | <span style="text-decoration: underline;">Jan Coogy</span> |
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Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | <span style="text-decoration: underline;">K031755</span> |
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Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

ter Use

(Optional Format 1-2-96)