FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3

K092645 · Fujirebio Diagnostics,Inc. · JJX · Sep 5, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092645
• Device Name: FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The FDI Glucose Controls are 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 the TrueTrack®, TrackEASE® and TRUEread™ meters and test strips.

Device Story

FDI Glucose Controls are buffered aqueous solutions containing D-Glucose, viscosity modifiers, preservatives, and red dye. Used by healthcare professionals and patients with diabetes to verify performance of TrueTrack®, TrackEASE®, and TRUEread™ glucose meters and test strips. Product is non-sterile, over-the-counter, and for external use only. User applies solution from a dropper-tipped bottle onto a test strip; meter reads result; user compares result against range printed on control vial label. Benefits include ensuring accuracy of glucose monitoring systems.

Clinical Evidence

No clinical data. Bench testing only. Stability established via accelerated shelf-life and open-vial studies (90 days). Traceability to NIST SRM 917c confirmed via reference clinical chemistry analyzer. Expected values determined by repeat analysis across multiple test strip lots.

Technological Characteristics

Buffered aqueous solution containing D-glucose, viscosity modifier, preservatives, and non-reactive ingredients. Form factor: plastic dropper-tipped bottle. Analyte: glucose. Levels: 3. Connectivity: None (standalone). Sterilization: Not specified.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to assess the performance of TrueTrack®, TrackEASE®, and TRUEread™ blood glucose meters and test strips.

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

• TRUEcontrol Glucose Control Levels 0, 1, and 2 (K030703)

Submission Summary (Full Text)

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K092645

510(k) Premarket Notification: FDI Glucose Controls Fujirebio Diagnostics, Inc.

#### 510(k) Summary 5

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, Inc. SEP 2 5 2009 940 Crossroads Blvd Seguin, TX 78155 [phone] ex. 210 Establishment Registration Number: 1643621

Contact Person:

Device Name: FD! Glucose Controls Levels 1, 2. and 3

John C. Gormley

Common Name: Single Analyte Control Solution, All Types (Assayed and Unassayed)

Classification Name: Quality Control Material (assayed and unassayed).

Class I per 21 CFR 862.1660

Product Code:

Classification:

Panel:

Chemistry

75 JJX

Name:

Predicate Devices:

Manufacturer: 510(k) No.:

TRUEcontrol Glucose Control Levels 0, 1, and 2 Home Diagnostics, Inc. k030703

Device Description:

The FDI Glucose Controls consist of a viscosityadjusted, aqueous liquid control solutions containing known quantities 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 nonhazardous and contains no human or animal derived materials.

Intended Use:

The FDI Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by

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510(k) Premarket Notification: FDI Glucose Controls Fujirebio Diagnostics, Inc.

> healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TrueTrack®, TrackEASE® and TRUEread™ meters and test strips.

# Comparison to Predicate Devices:

| Characteristic/<br>Aspect | Predicate Device | New Product |
|---------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Name | TRUEcontrol Glucose Control | FDI Glucose Controls |
| 510(k), Date | K030703<br>08/11/2003 | |
| Number of Levels | 3 | 3 |
| Analyte | Glucose | Glucose |
| Target Range<br>(mg/dL) | 83 - 121(1) | 81 - 121(2) |
| | 173 - 256(1) | 172 - 257(2) |
| | 341 - 516(1) | 328 - 490(2) |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Fill Volume | 3.0 mL | 3.6 mL |
| Color | Red | Red |
| Matrix | Water, D-glucose, buffers,<br>viscosity enhancing agents,<br>inorganic salts, amaranth, and<br>preservatives. | Buffered aqueous solution of D-<br>Glucose, a viscosity modifier,<br>preservatives, and other non-<br>reactive ingredients |
| Indications for Use | To check the performance the<br>TrueTrack®, TrackEASE® and<br>TRUEreadTM meters and test<br>strips | To check the performance of the<br>TrueTrack®, TrackEASE® and<br>TRUEreadTM meters and test<br>strips |
| Target Population | Professional and home use | Professional and home use |

(1) Estimated from the manufacturer's published control ranges.

. .

(2)Based on a +/- 5% glucose concentration variability lot-to-lot and +/- 15% range

#### Performance Studies:

Tests were performed to verify specific performance characteristics:

- 1. Accelerated and Real-time 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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES : USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Fuirebio Diagnostics, Inc. c/o Mr. John C. Gormley Director of Quality & Regulatory Affairs 940 Crossroads Blvd. Seguin, TX 78155

SEP 2 5 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

k092645 Re: Trade Name: FDI Glucose Controls Levels 1, 2 and 3 Regulation Number: 21 CFR §862.1660 Regulation Name: Ouality Control Material (assayed and unassayed). Regulatory Class: Class I, Reserved Product Codes: JJX Dated: August 25, 2009 Received: August 27, 2009

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (QSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, Ph.D. 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): K092645

Device Name: FDI Glucose Controls

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 TrueTrack®, TrackEASE® and TRUEread™ meters and test strips.

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

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

X

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

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

k092645 510(k) -