FDI GLUCOSE CONTROL SOLUTIONS

K102260 · Fujirebio Diagnostics,Inc. · JJX · Sep 24, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102260
• Device Name: FDI GLUCOSE CONTROL SOLUTIONS
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The FDI 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 the FreeStyle Lite Blood Glucose Monitor.

Device Story

FDI Glucose Control Solution is an aqueous, viscosity-adjusted liquid control containing a known quantity of glucose. Used by healthcare professionals and patients with diabetes to verify performance of FreeStyle Lite Blood Glucose Monitors. Product is supplied in plastic dropper-tipped bottles; red coloration aids visual confirmation of application to test strips. Non-hazardous; contains no human or animal-derived materials. Device functions as a quality control material to ensure accuracy of blood glucose monitoring systems.

Clinical Evidence

No clinical data. Bench testing only. Stability testing included real-time shelf-life studies (24 months) and open-vial stability (90 days) using a clinical chemistry analyzer. Traceability established against NIST SRM917c.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifier, preservatives, and red dye. Non-hazardous; no human/animal-derived materials. Form factor: plastic dropper-tipped bottle (3.6 mL). Standalone use.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to assess the performance of the FreeStyle Lite 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

• AbT Glucose Control Solution (k083549)

Submission Summary (Full Text)

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102260 EP 2 4 2010

#### 5. 510(k) Summary

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. (FDI) 940 Crossroads Blvd Seguin, TX 78155 [phone] ex. 213 Establishment Registration Number: 1643621 Contact Person: Kent Pruett Device Name: FDI 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: Name: AbT Glucose Control Solution Manufacturer: Fujirebio Diagnostics, Inc. 510(k) No.: : k083549 Device Description: The FDI 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 nonhazardous and contains no human or animal derived materials.

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### Intended Use:

- The FDI 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 FreeStyle Lite Blood Glucose Monitor

| Characteristic/<br>Aspect | Predicate Device No. 1 | New Product |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Name | AbT Glucose Control Solution | FDI Glucose Control Solution |
| 510(k), Date | K083549, 12/22/2008 | |
| Number of<br>Levels | 1 | 1 |
| Analyte | Glucose | Glucose |
| Target (mg/dL) | 88 | 88 |
| Target Range<br>(mg/dL) | 80 – 130(1) | 75 - 125 |
| 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 is<br>manufactured by FDI. |
| Indications for<br>Use | Used to check the performance of<br>FreeStyle and FreeStyle Lite Blood<br>Glucose Systems. | Used to check the performance<br>of FreeStyle <i>Lite</i> Blood Glucose<br>Systems. |
| Target<br>Population | Professional and home use | Professional and home use |

## Comparison to Predicate Device:

(1) FDI's target range for the Liberty Glucose Control.

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# 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/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three swooping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

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

SEP 2 4 2010

k102260 Re:

> Trade Name: FDI Glucose Control Solution Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: August 10, 2010 Received: August 10, 2010

Dear Mr. Pruett:

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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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 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 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 [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

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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#### Indications for Use Statement 4.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K102260

FDI Glucose Control Solution Device Name:

SEP 2 4 2010

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 Lite Blood Glucose Monitor.

Prescription Use X (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)

Dia

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

510(k) K10 22-60