GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK

K081403 · Bionostics, Inc. · JJX · Jul 25, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081403
• Device Name: GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
• Applicant: Bionostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

Glucose Meter-Check" Solution is intended to assess the performance of the following Roche ACCU-CHEK blood glucose test systems: Roche ACCU-CHEK Advantage using Comfort Curve® test strips, Roche ACCU-CHEK Active®, Roche ACCU-CHEK Aviva®, Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus®. The Meter-Check Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use

Device Story

Glucose Meter-Check Control Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution; used to verify performance of Roche ACCU-CHEK blood glucose monitoring systems. The solution contains D-glucose at a concentration simulating normal fasting blood glucose levels; packaged in plastic bottles with dropper tips for application to test strips. The solution is red-colored to aid visibility during dispensing. Used by healthcare professionals and patients with diabetes mellitus in clinical or home settings. The user applies the solution to a test strip; the meter reads the strip; the user compares the result to the assigned range to verify system accuracy. Benefits include ensuring reliable blood glucose monitoring performance.

Clinical Evidence

No clinical data. Bench testing only. Stability established via real-time and accelerated studies (24-month closed bottle, 90-day open bottle) with <5% glucose concentration change. Value assignment performed using YSI 2300 reference method; target ranges calculated as mean ± 15%.

Technological Characteristics

Viscosity-adjusted, aqueous liquid control solution containing D-glucose. Non-hazardous; contains no human or animal-derived materials. Packaged in plastic bottles with dropper tips. Designed to simulate whole blood response on Roche ACCU-CHEK systems.

Indications for Use

Indicated for use by healthcare professionals and people with diabetes mellitus to assess the performance of Roche ACCU-CHEK blood glucose test systems (Aviva, Active, Advantage, Compact, and Compact Plus).

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Accu-Chek AVIVA Control (K043474)
• Accu-Chek ACTIVE Control (K012324)
• Accu-Chek ADVANTAGE Control (K032552)
• Accu-Chek COMPACT Control (K022171)
• SMS Glucose Control (K070506)

Submission Summary (Full Text)

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L081403

Image /page/0/Picture/1 description: The image shows the word "BIONOSTICS" in large, bold, black letters. Below that, in a smaller font, are the words "Quality Solutions". The words "Quality Solutions" are in a slightly italicized font.

# 510(k) Summary2

## JUL 2 5 2008

| (a) (1) | Submitter's name, address<br>Bionostics, Inc.<br>7 Jackson Road<br>Devens, MA 01432 | Contact Person<br>Randy Byrd<br>VP, Chief Technical Officer<br>[phone] x 272 |
|---------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| | Date of preparation of this summary: | 16 May 2008 |
| (2) | Device trade or proprietary name: | Glucose Meter-Check™ Control Solution<br>for Roche ACCU-CHEK |

Device common or usual name or classification name:

75 JJX, single (specified) analyte controls (assayed and unassayed)

| | CLASSIFICATION | | |
|---------------------------------|----------------|-------|-----------------------|
| PRODUCT NOMENCLATURE | NUMBER | CLASS | PANEL |
| SINGLE ANALYTE CONTROL SOLUTION | 862.1660 | 1 | 75 CLINICAL CHEMISTRY |

#### l. Substantial Equivalence

Glucose Meter-Check" Solution is substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use:

### Comparison of Glucose Meter-Check" Control Solution to predicate devices for substantial equivalency

| Product | Glucose<br>Meter-Chek<br>Solution | Accu-Chek<br>AVIVA Control | Accu-Chek<br>ACTIVE<br>Control | Accu-Chek<br>ADVANTAGE<br>Control | Accu-Chek<br>COMPACT<br>Control | SMS Glucose<br>Control |
|--------------------|-----------------------------------|----------------------------|--------------------------------|-----------------------------------|---------------------------------|------------------------|
| 510(k), Date | | K043474<br>04.27.05 | K012324<br>12.05.01 | K032552<br>09.12.03 | K022171<br>07.23.02 | K070506<br>04.18.07 |
| Net Fill | 4 mL | 2.5 mL | 4 mL | 4 mL | 3 mL | 3.6 mL |
| Color | red | blue | clear | blue | dark blue | red |
| Analyte | glucose | glucose | glucose | glucose | glucose | glucose |
| Container | plastic vial | plastic vial | plastic vial | plastic vial | plastic vial | plastic vial |
| Matrix | aqueous | aqueous | aqueous | aqueous | aqueous | aqueous |
| Level | normal | low high | low high | low high | low high | normal |
| Mid Assigned Range | 107 | 40 300 | 54 173 | 61 342 | 83 410 | 169 |

*Mid Assigned Range is mean of assigned ranges for each meter (Accuse Meter-Check and SMS Glucose Control)

² This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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### II. Description of the new device

Glucose Meter-Check Control Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Meter-Check "Control Solution is intended for use to verify the performance of the Roche ACCU-CHEK brand BGM Systems listed in the package insert at glucose levels within the normal fasting blood glucose range for non-diabetic persons. This mid-level glucose concentration will complement the current, low and high glucose concentrations available in quality control products distributed by Roche Diagnostics for these same BGM systems. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip.

Glucose Meter-Check Control Solution is a non-hazardous aqueous solution containing no human or animal-derived materials.

### (2) Intended use of the device

Glucose Meter-Check "Control Solution is intended for in vitro diagnostic use to assess the performance of the Roche ACCU-CHEK blood glucose test systems: Aviva, Active, Advantage and Compact and Compact Plus by healthcare professionals and in the home by people with diabetes mellitus.

### (6) Technological characteristics of the device.

This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose and has been optimized to simulate the response of whole blood on the Roche ACCU-CHEK blood glucose test systems. The solution contains no hazardous, human or animal derived components.

### (b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.

Tests were conducted to verify specific performance requirements:

- a) Closed bottle stability
- b) Stability after opening
- Bias to glucose as determined by YSI 2300 c)
- d) Test precision and range
- (b) (2) Summary of clinical tests submitted with the premarket notification for the device. N/A

### (b) (3) Conclusions drawn from the clinical and non-clinical trials.

Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bionostics, Inc. c/o Mr. Randy Byrd Vice President, Chief Tcchnical Officer 7 Jackson Road Devens, MA 01432

JUL 2 5 2008

Re: k081403

Trade Name: Glucose Meter-Check™ Control Solution for Roche ACCU-CHEK Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: July 15, 2008 Received: July 16, 2008

Dear Mr. Byrd:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indication for Use

# 510(k) Number (if known): K081403

## Device Name: Glucose Meter-Check" Control Solution for Roche ACCU-CHEK

Indication For Use:

Glucose Meter-Check" Solution is intended to assess the performance of the following Roche ACCU-CHEK blood glucose test systems:

Roche ACCU-CHEK Advantage using Comfort Curve® test strips '

- Roche ACCU-CHEK Active® ・
- · Roche ACCU-CHEK Aviva®

Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® .

The Meter-Check Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use V (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081403