AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION

K080273 · Fujirebio Diagnostics Texas, Inc. · JJX · Aug 8, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080273
• Device Name: AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION
• Applicant: Fujirebio Diagnostics Texas, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The FDTX Glucose Control Solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of Bayer Ascensia BREEZE 2 Blood Glucose Monitor.

Device Story

FDTX Glucose Control Solution is a viscosity-adjusted, aqueous liquid containing a known quantity of glucose; used as a quality control material. Packaged in plastic dropper-tipped bottles; red coloration aids visual confirmation of application to test strips. Used by healthcare professionals and patients with diabetes in clinical or home settings to verify performance of the Bayer Ascensia BREEZE 2 Blood Glucose Monitor. The solution is applied to test strips; the monitor reads the glucose level; the user compares the result against the target range to ensure the system is functioning correctly. Benefits include increased confidence in blood glucose monitoring accuracy.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and 13-week open-vial) and traceability to NIST SRM917b were performed. Expected values were determined using the Bayer Ascensia Breeze 2 monitor across three lots of test strips.

Technological Characteristics

Viscosity-adjusted aqueous liquid control solution containing D-Glucose, preservatives, and nonreactive ingredients. Packaged in plastic dropper-tipped bottles. Traceable to NIST SRM917b. No human or animal-derived materials.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to assess the performance of the Bayer Ascensia BREEZE 2 Blood Glucose Monitor.

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

• Bayer Ascensia Breeze 2 Normal Control (k062347)
• Liberty Normal Glucose Control Solution (k060426)

Submission Summary (Full Text)

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K080273

### 5. 510(k) Summary

# AUG - 8 2008

| Introduction: | 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. | | | | | | | | | | | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|----------------------------------------|---------------|------------------------|-------------|---------|-------|-----------------------------------------|---------------|--------------------------|-------------|---------|
| Submitter: | Fujirebio Diagnostics Texas Inc.<br>940 Crossroads Blvd<br>Seguin, TX 78155<br>[phone] ex. 210<br>Establishment Registration Number: 1643621 | | | | | | | | | | | | |
| Contact Person: | John C. Gormley | | | | | | | | | | | | |
| Device Name: | FDTX Glucose Control Solution | | | | | | | | | | | | |
| Common Name: | Single Analyte Control Solution, All Types (Assayed and Unassayed) | | | | | | | | | | | | |
| Classification Name: | Quality Control Material (assayed and unassayed). | | | | | | | | | | | | |
| Classification: | Class I per 21 CFR 862.1660 | | | | | | | | | | | | |
| Product Code: | 75 JJX | | | | | | | | | | | | |
| Panel: | Chemistry | | | | | | | | | | | | |
| Predicate Devices: | <table><tr><td>Name:</td><td>Bayer Ascensia BREEZE 2 Normal Control</td></tr><tr><td>Manufacturer:</td><td>Bayer Healthcare, LLC.</td></tr><tr><td>510(k) No.:</td><td>K062347</td></tr><tr><td>Name:</td><td>Liberty Normal Glucose Control Solution</td></tr><tr><td>Manufacturer:</td><td>Liberty Healthcare Group</td></tr><tr><td>510(k) No.:</td><td>K060426</td></tr></table> | Name: | Bayer Ascensia BREEZE 2 Normal Control | Manufacturer: | Bayer Healthcare, LLC. | 510(k) No.: | K062347 | Name: | Liberty Normal Glucose Control Solution | Manufacturer: | Liberty Healthcare Group | 510(k) No.: | K060426 |
| Name: | Bayer Ascensia BREEZE 2 Normal Control | | | | | | | | | | | | |
| Manufacturer: | Bayer Healthcare, LLC. | | | | | | | | | | | | |
| 510(k) No.: | K062347 | | | | | | | | | | | | |
| Name: | Liberty Normal Glucose Control Solution | | | | | | | | | | | | |
| Manufacturer: | Liberty Healthcare Group | | | | | | | | | | | | |
| 510(k) No.: | K060426 | | | | | | | | | | | | |
| Device Description: | The FDTX Glucose Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is non- | | | | | | | | | | | | |

:

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> hazardous and contains no human or animal derived materials.

The FDTX Glucose Control Solution is intended for in Intended Use: vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of Bayer Ascensia BREEZE 2 Blood Glucose Monitor.

## Comparison to Predicate Device:

| Characteristic/<br>Aspect | Predicate Device No. 1 | Predicate Device No. 2 | New Product |
|---------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Name | Ascensia BREEZE 2<br>Control Normal | Liberty Glucose Normal<br>Control Solution | FDTX Glucose Control<br>Solution |
| 510(k), Date | K062347, 11/21/2006 | K060426, 3/09/2006 | k080273 |
| Number of<br>Levels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Target (mg/dL) | 100 | 100 | 100 |
| Target Range<br>(mg/dL) | 85 - 130 | 113 - 170 | 85 - 130 |
| Container | Plastic bottle with<br>dropper-tip | Plastic bottle with<br>dropper-tip | Plastic bottle with<br>dropper-tip |
| Fill Volume | 2.5 mL | 3.6 mL | 3.6 mL |
| Color | Blue | Red | Red |
| Matrix | Blue solution<br>containing a measured<br>amount of glucose. | Buffered aqueous<br>solution of D-Glucose, a<br>viscosity modifier,<br>preservatives, and other<br>non-reactive ingredients | Buffered aqueous<br>solution of D-Glucose, a<br>viscosity modifier,<br>preservatives, and other<br>non-reactive ingredients |
| Indications for<br>Use | For use as quality<br>control check to verify<br>that the BREEZE 2<br>meter and test strips<br>are working properly. | To check the<br>performance of the Bayer<br>Ascensia DEX 2/DEX<br>and BREEZE Blood<br>Glucose Monitors. | To check the<br>performance of the Bayer<br>Ascensia BREEZE 2 Blood<br>Glucose Monitor. |
| Target<br>Population | Professional and home<br>use | Professional and home<br>use | Professional and home<br>use |

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### Performance Studies: Tests were performed to verify specific performance characteristics:

- 1. Stability
- 2. Open Vial
- 3. Test precision

Conclusion: Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Fujirebio Diagnostics Texas, Inc c/o Mr. John Gormley, Director of Quality & Regulatory Affairs 940 Crossroads Boulevard Seguin, TX 78155

AUG - 8 2008

Re: K080273 Trade/Device Name: FDTX Glucose Control Solution Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I , reserved Product Code: JJX Dated: June 17, 2008 Received: June 17, 2008

Dear Mr. Gormley:

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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#### Indications for Use Statement 4.

510(k) Number (if known): k080273

FDTX Glucose Control Solution Device Name:

Indications for Use:

For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the BREEZE 2 Blood Glucose Monitor.

Prescription Use (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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

510(k) K080273