FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE

K103450 · Fujirebio Diagnostics,Inc. · JJX · Jan 25, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103450
• Device Name: FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The FDI Glucose Control Solution for FreeStyle Intended Use: 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 FreeStyle Blood Glucose Monitor

Device Story

Viscosity-adjusted, aqueous liquid control solution containing known quantity of glucose; packaged in plastic dropper-tipped bottles. Used by healthcare professionals and patients with diabetes mellitus in clinical or home settings to verify performance of FreeStyle Blood Glucose Monitors. Red coloration allows visual confirmation of application to test strips. Non-hazardous; contains no human or animal-derived materials. Provides a known glucose concentration to check monitor accuracy; helps ensure reliable blood glucose readings for patient management.

Clinical Evidence

Bench testing only. Studies performed to verify performance characteristics included stability testing, open vial testing, and mean and variance comparison.

Technological Characteristics

Aqueous buffered solution containing D-Glucose, viscosity modifier, preservatives, and non-reactive ingredients. Packaged in plastic dropper-tipped bottles (3.6 mL fill). Red colorant added for application visibility. Non-hazardous. No software or electronic components.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to assess the performance of FreeStyle Blood Glucose Monitor systems.

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

• FDI Glucose Control Solution (K102260)

Submission Summary (Full Text)

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K103450

510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle
Fujirebio Diagnostics, Inc.

# JAN 2 5 2011

### 5. 510(k) Summary

| Introduction: | According to the requirements of 21 CFR 807.92, the<br>following information provides sufficient detail to<br>understand the basis for a determination of<br>substantial equivalence. | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Submitter: | Fujirebio Diagnostics, Inc. (FDI)<br>940 Crossroads Blvd<br>Seguin, TX 78155<br>[phone] ex. 213<br>Establishment Registration Number: 1643621 | |
| Contact Person: | Kent Pruett | |
| Device Name: | FDI Glucose Control Solution for FreeStyle | |
| Common Name: | Single Analyte Control Solution, All Types (Assayed<br>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: | Name:<br>Manufacturer:<br>510(k) No.: | FDI Glucose Control Solution<br>Fujirebio Diagnostics, Inc.<br>k102260 |
| Device Description: | The FDI Glucose Control Solution for FreeStyle<br>consists of a viscosity-adjusted, aqueous liquid<br>control solution containing a known quantity of<br>glucose. The product is packaged in plastic dropper<br>tipped bottles for easy application of the control<br>solutions to the test strips and a red coloration to aid<br>the user to visually confirm application of the control.<br>The product is non-hazardous and contains no human<br>or animal derived materials. | |

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510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle Fujirebio Diagnostics, Inc.

The FDI Glucose Control Solution for FreeStyle Intended Use: 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 FreeStyle Blood Glucose Monitor

| Characteristic/<br>Aspect | Predicate Device No. 1 | New Product |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Name | FDI Glucose Control Solution | FDI Glucose Control Solution<br>for FreeStyle |
| 510(k), Date | K102260, 09/24/2010 | |
| Number of<br>Levels | 1 | 1 |
| Analyte | Glucose | Glucose |
| Target (mg/dL) | 88 | 88 |
| Target Range<br>(mg/dL) | 75 – 125(1) | 70-120 |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Fill Volume | 3.6 mL | 3.6 mL |
| Color | Red | Red |
| Matrix | Buffered aqueous solution of D-Glucose, a<br>viscosity modifier, preservatives, and other<br>non-reactive ingredients | Identical to Predicate 1 which<br>is manufactured by FDI. |
| Indications for<br>Use | Used to check the performance of FreeStyle<br>Lite Blood Glucose Systems. | Used to check the<br>performance of FreeStyle<br>Blood Glucose Systems. |
| Target<br>Population | Professional and home use | Professional and home use |

## Comparison to Predicate Device:

TFFDI's target range for the Freestyle Glucose Control.

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510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle Fujirebio Diagnostics, Inc.

.

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

- 1. Stability
- 2. Open Vial
- 3. Mean and Variance Comparison

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/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Fujirebio Diagnostics, Inc. c/o Mr. Kent Pruett Director Quality Assurance and Regulatory Affairs 940 Crossroads Blvd. Seguin. Texas 78155

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

· JAN 2 5 201

k103450 Trade Name: FDI Glucose Control Solution for FreeStyle Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: November 1, 2010 Received: November 24, 2010

Dear Mr. Pruett:

Re:

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).

LANY

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 80) and 809), 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 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 [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courtney 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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510(k) Premarket Notification: FDI Glucose Control Solution Fujirebio Diagnostics, Inc.

#### 4. Indications for Use Statement

510(k) Number (if known): K103450

FDI Glucose Control Solution for FreeStyle 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 FreeStyle 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)

Signature of Owner or Officer

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

510(k) 1/103452