FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA

K123612 · Fujirebio Diagnostics,Inc. · JJX · Jan 17, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123612
• Device Name: FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The FDI Glucose Control Solution is intended for use with Aviva Plus test strip when used on the Accu-Chek® Aviva blood glucose meter. The control solution is used with the Aviva Plus test strips to check that the meter and test strips are working together properly.

Device Story

FDI Glucose Control Solution is a viscosity-adjusted, aqueous liquid containing a known quantity of glucose; includes red dye for visual confirmation of application. Used by professionals and patients in home settings to verify performance of Accu-Chek Aviva blood glucose meters and Aviva Plus test strips. User applies control solution to test strip; meter reads glucose concentration; user compares result to target range printed on vial label. Ensures system accuracy; helps prevent erroneous blood glucose readings. Non-hazardous; no human/animal-derived materials.

Clinical Evidence

Bench testing only. Real-time stability study supports 24-month shelf life at 15-30°C. Open-vial stability study supports 90-day usage. Value assignment performed using a single Accu-Chek Aviva monitor across three test strip lots; traceability established to NIST SRM 917b.

Technological Characteristics

Aqueous liquid control solution; contains D-Glucose, viscosity modifier, buffer, salt, preservatives, and FD&C Red #40. Packaged in plastic dropper-tipped bottles. Traceable to NIST SRM 917b. No electronic components or software.

Indications for Use

Indicated for professional and home use to verify proper function of the Accu-Chek Aviva blood glucose meter and Aviva Plus 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.

Submission Summary (Full Text)

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K123612

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510(k) Premarket Notification: FDI Glucose Control for Aviva Plus Fujirebio Diagnostics, Inc.

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| 5 | | 510(k) Summary |
|---|--|----------------|
|---|--|----------------|

# JAN 1 7 2013

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| 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.<br>940 Crossroads Blvd<br>Seguin, TX 78155<br>[phone] ex. 210<br>Establishment Registration Number: 1643621 |
| Contact Person: | Kent Pruett |
| Device Name: | FDI Glucose Control Solution for use with Accu-Chek<br>Aviva |
| 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<br>Reserved |
| Product Code: | 75 JJX |
| Panel: | Chemistry |
| Predicate Devices: | Name: ACCU-CHEK Aviva Control Level 1<br>Manufacturer: Roche Diagnostics<br>510(k) No.: k043474 |
| Device Description: | The FDI Glucose Control Solution for Aviva consists<br>of a viscosity-adjusted, aqueous liquid control solution<br>containing a known quantity of glucose. The product<br>is packaged in plastic dropper tipped bottles for easy<br>application of the control solutions to the test strips<br>and a red coloration to aid the user to visually confirm<br>application of the control. The product is non-<br>hazardous and contains no human or animal derived<br>materials. |
| Intended Use: | The FDI Glucose Control Solution is intended for use<br>with Aviva Plus test strip when used on the Accu-<br>Chek® Aviva blood glucose meter. The control |

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solution is used with the Aviva Plus test strips to check that the meter and test strips are working together properly.

### Comparison to Predicate Devices:

| Characteristic/<br>Aspect | Predicate Device No. 1 | New Product |
|---------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | ACCU-CHEK Aviva Control<br>Level 1 | FDI Glucose Control<br>Solution for Accu-Chek<br>Aviva |
| 510(k), Date | K043474<br>04/27/2005 | |
| Number of<br>Levels | 1 | 1 |
| Analyte | Glucose | Glucose |
| Target Range<br>(mg/dL) | $25 - 55^{(2)}$ | $23 - 53^{(1)}$ |
| Container | Plastic bottle with<br>dropper-tip | Plastic bottle with<br>dropper-tip |
| Fill Volume | 2.5 mL | 3.6 mL |
| Color | Blue | Red |
| Matrix | Glucose, buffer, salts,<br>non-reactive ingredients,<br>preservative, FD & C<br>Blue #1 | Water, D-Glucose, a<br>viscosity modifier, buffer,<br>salt, preservatives, and<br>FD&C Red #40 |
| Indications for<br>Use | Checks that the meter<br>and test strips are<br>working properly to give<br>reliable results. | The FDI Glucose Control<br>Solution is intended for<br>use with Aviva Plus test<br>strip when used on the<br>Accu-Chek® Aviva blood<br>glucose meter. The<br>control solution is used<br>with the Aviva Plus test<br>strips to check that the<br>meter and test strips are<br>working together<br>properly. |
| Target<br>Population | Professional and home<br>use | Professional and home<br>use |

(1) Based on a +/- 5% glucose concentration variability lot-to-lot and +/- 15 mg/dl range (2)Derived from the control ranges assigned by the manufacturer

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

- Real Time Stability: Samples were periodically removed and tested in triplicate on a commercially available clinical chemistry analyzer. The study supports a shelf life of 24 months when stored at 15-30°C.

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510(k) Premarket Notification: FDI Glucose Control for Aviva Plus Fujirebio Diagnostics, Inc.

- Open Vial Stability: A number of test and control vials were evaluated for 13 weeks. Each day all vials were opened, allowed to stand for ten minutes, then closed and stored at room temperature. Each week one test group vial was assayed and one control group vial was assayed in triplicate using the ACE Glucose assav. The Control vial was opened on the date of performing the assay and then discarded after testing was complete. The study supports the claimed open vial stability of 90 days when stored at 15 - 30℃.
- Test Precision: Studies performed per CLSI Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition. CLSI document EP5-A2: 2004. No precision claims will be made for this product.
- Value Assignment: The control solutions are analyzed using a single AVIVA monitor using three different lots of test strips, 10 replicates per strip lot, over three days. Acceptable ranges are based on predetermined acceptance criteria established by the manufacturer for glucose recovery for each lot. The glucose control value ranges are lot dependent; therefore the range for each lot is printed on the control solution vial label.
- Traceability: The control is traceable to an in-house 45 mg/dL Standard traceable to the NIST Standard Reference Material 917b. The inhouse 45 mg/dL Standard is produced using SRM917.

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 & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### January 17, 2012

Fujirebio Diagnostics, Inc. c/o Kent Pruett 940 Crossroads Blvd. Seguin, TX 78155

Re: k123612

Trade/Device Name: FDI Glucose Control Solution for use with Accu-Chek Aviva Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: I. reserved . Product Code: JJX Dated: November 23, 2012 Received: December 20, 2012

#### 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Pruett

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Medica]Devices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

### for Ruth A. Chesler

Courtney H. Lias, Ph.D

Director, Division of Chemistry and Toxicology Devices

Office of In Vitro Diagnostics

and Radiological Health

Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): k123612

Device Name: FDI Glucose Control Solution for use with Accu-Chek Aviva

Indications For Use: The FDI Glucose Control Solution is intended for use with Aviva Plus test strip when used on the Accu-Chek® Aviva blood glucose meter. The control solution is used with the Aviva Plus test strips to check that the meter and test strips are working together properly.

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

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

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

Katherine Serrano 2013.01.17 13:04:13 -05'00'

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

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