GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002

K082395 · Bionostics, Inc. · JJX · Sep 18, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082395
• Device Name: GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002
• Applicant: Bionostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Glucose Meter-Check™ Control Solution is intended for in vitro diagnostic use to assess the performance of the Bayer Ascensia blood glucose test systems: Breeze 2, Contour, Elite and DEX 2 by healthcare professionals and in the home by people with diabetes mellitus.

Device Story

Glucose Meter-Check Control Solution is a single-level, viscosity-adjusted, aqueous liquid control solution used to verify the performance of Bayer Ascensia blood glucose test systems. The solution contains D-glucose and is formulated to simulate the response of whole blood on test strips. It is packaged in plastic bottles with dropper tips for manual application by healthcare professionals or patients with diabetes at home. The red-colored liquid allows users to visually confirm the solution has been dispensed onto the test strip. By comparing the meter's reading of the control solution against expected values, users can ensure the accuracy and functionality of their glucose monitoring system, thereby supporting reliable clinical decision-making for diabetes management.

Clinical Evidence

No clinical data. Bench testing only, including closed bottle stability, stability after opening, and test mean response/precision data.

Technological Characteristics

Viscosity-adjusted, aqueous liquid control solution containing D-glucose. Non-hazardous; contains no human or animal-derived materials. Packaged in plastic vials with dropper tips. Standalone, manual application.

Indications for Use

Indicated for use by healthcare professionals and people with diabetes mellitus to assess the performance of Bayer Ascensia blood glucose test systems (Breeze 2, Contour, Elite, DEX 2).

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

• Ascensia Breeze 2 (K062347)
• Ascensia Contour (K023657)
• Ascensia Elite (K043311)
• Ascensia DEX 2 (K023584)
• SMS Glucose Control (K070506)

Submission Summary (Full Text)

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1082395

SEP 1 8 2008

# 510(k) Summary2

BIONOSTIC

Quality Solutions

- Contact Person Submitter's name, address (a) (1) Bionostics, Inc. Kathleen Storro Sr. Dir. QA/RA 7 Jackson Road [phone] x 220 Devens, MA 01434 18 August 2008 Date of preparation of this summary: Glucose Meter-Check™ Control Solution (2) Device trade or proprietary name: For Bayer Ascensia Blood Glucose Test Systems
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" Control Solution for Bayer Ascensia Blood Glucose Test Systems 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-Check<br>Solution | Ascensia<br>Breeze 2 | Ascensia<br>Contour | Ascensia<br>Elite | Ascensia<br>DEX 2 | SMS Glucose<br>Control |
|--------------------------------|------------------------------------|----------------------|---------------------|---------------------|---------------------|------------------------|
| 510(k), Date | | K062347<br>11-21-06 | K023657<br>05-11-04 | K043311<br>12-22-04 | K023584<br>11-20-02 | K070506<br>04-18-07 |
| Net Fill | 4 mL | 2.5 mL | 2.5 mL | 2.5 mL | 2.5 mL | 3.6 mL |
| Color | red | red | red | red | red | Red |
| Analyte | glucose | glucose | glucose | glucose | glucose | Glucose |
| Glucose (% w/v) | 0.1% | 0.10% | 0.12% | 0.10% | 0.15% | 0.12% |
| Container | plastic vial | plastic vial | plastic vial | plastic vial | plastic vial | plastic vial |
| Matrix | aqueous | aqueous | aqueous | aqueous | aqueous | aqueous |
| Level | normal | normal | normal | normal | normal | normal |
| Mid Assigned<br>Value* (mg/dL) | 86 | 108 | 122 | 88 | 140 | 110 |

* Mid Assigned Value is the mean of assigned values for each meter (Ascensia Contour for Glucose 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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#### ll. 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 Bayer Ascensia brand blood glucose test systems listed in the package insert at glucose levels within the normal fasting blood glucose range for non-diabetic persons. 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.

#### Intended use of the device (a) (1)

Glucose Meter-Check" Control Solution is intended for in vitro diagnostic use to assess the performance of the Bayer Ascensia blood glucose test systems: Breeze 2, Contour, Elite and DEX 2 by healthcare professionals and in the home by people with diabetes mellitus.

#### Technological characteristics of the device. (a) (2)

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 Bayer Ascensia blood glucose test systems. The solution contains no hazardous, human or animal derived components.

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

Tests were conducted to verify specific performance requirements:

- a) Closed bottle stability
- b) Stability after opening
- c) Test mean response and precision data
- Summary of clinical tests submitted with the premarket notification for the device. (b) (2) 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bionostics, Inc. c/o Ms Kathleen Storro 7 Jackson RD. Devens, MA 01434

# SEP 1 8 2008

#### k082395 Re:

Trade/Device Name: Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucosc Test Systems Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Codes: JJX Dated: August 18, 2008 Received: August 20, 2008

Dear Ms. Storro:

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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## Page 2 -

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.

Yean 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): K082395

Device Name: Glucose Meter-Check" Control Solution for Bayer Ascensia Blood Glucose Test Systems

Indication For Use: Glucose Meter-Check" Control Solution is intended to assess the performance of the following Bayer blood glucose test systems:

- Bayer Ascensia Breeze® 2 .
- Bayer Ascensia Contour® .
- Bayer Ascensia Elite® .
- Bayer Ascensia DEX® 2

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

For In Vitro Diagnostics Use

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

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

And/Or

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

Anr Chappie

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

510(k) K082395