FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE

K133197 · Fujirebio Diagnostics,Inc. · JJX · Jan 17, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133197
• Device Name: FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The FDI Glucose Controls are intended for use with Embrace No Code blood glucose meter and test strips. The controls are used to check that the meter and test strips are working together properly. The FDI Glucose Controls for the Embrace No Code are intended for use by healthcare professionals and people with diabetes mellitus at home.

Device Story

FDI Glucose Controls consist of viscosity-adjusted, aqueous liquid solutions containing known glucose concentrations; packaged in red-colored, dropper-tipped plastic bottles for visual confirmation of application. Used by healthcare professionals and patients with diabetes at home to verify proper function of Embrace No Code blood glucose meters and test strips. User applies control solution to test strip; meter reads glucose level; user compares result against lot-specific target range printed on vial label. Validates system performance; ensures accuracy of patient blood glucose readings; aids in diabetes management.

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 period at 15–30°C. Value assignment performed using Embrace No Code monitor across three lots of test strips; ranges calculated as ±20% of the mean. Traceability established to NIST SRM 917.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifiers, and preservatives. Packaged in plastic dropper-tipped bottles. Non-hazardous; no human or animal-derived materials. Traceable to NIST SRM 917. Shelf life: 24 months. Open-vial stability: 90 days.

Indications for Use

Indicated for healthcare professionals and patients with diabetes mellitus to validate the performance of the Embrace No Code blood glucose monitoring system.

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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Ki33197

.

510(k) Premarket Notification: FDI Glucose Controls for the Embrace No Code Fujirebio Diagnostics, Inc.

JAN 1 7 2014

510(k) Summary

| Date of Preparation: | January 10, 2014 | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Introduction: | According to the requirements of 21 CFR 807.92, the<br>following information provides sufficient detail<br>to<br>understand the basis for a determination<br>of<br>substantial equivalence. | |
| Submitter: | Fuiirebio Diagnostics, Inc.<br>940 Crossroads Blvd<br>Sequin. TX 78155<br>Phone: [phone] ex. 210<br>Fax: [phone]<br>Establishment Registration Number: 1643621 | |
| Contact Person: | Kent Pruett | |
| Device Name: | FDI Level I and Level II Glucose Controls for the<br>Embrace No Code | |
| Common Name: | Single Analyte Control Solution, All Types (Assaved<br>and Unassayed) | |
| Classification Name: | Quality Control Material (assayed and unassayed). | |
| Classification: | Class I, Reserved per 21 CFR 862.1660 | |
| Product Code: | JJX | |
| Panel: | 75 (Chemistry) | |
| Predicate Device: | Name: | Omnis Embrace Glucose Control<br>Solutions |
| | Manufacturer:<br>510(k) No.: | Bionostics<br>k091914 |
| Device Description: | The FDI Glucose Controls for the Embrace No Code<br>consist of a viscosity-adjusted, aqueous liquid control<br>solution containing known quantities of glucose. The<br>product is packaged in plastic dropper tipped bottles<br>for easy application of the control and a red coloration<br>to aid the user to visually confirm application. The<br>product is non-hazardous and contains no human or<br>animal derived materials. | |

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510(k) Premarket Notification: FDI Glucose Controls for the Embrace No Code Fujirebio Diagnostics, Inc.

Intended Use:

The FDI Glucose Controls are intended for use with Omnis Embrace No Code blood glucose meter and test strips. The controls are used to check that the meter and test strips are working together properly.

| Characteristic/<br>Aspect | Predicate Device | New Product |
|----------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Name | Omnis Embrace Glucose Control<br>Solutions | FDI Level I and Level II Glucose<br>Controls for the Embrace No<br>Code |
| 510(k), Date | k091914<br>11/06/2009 | |
| Number of Levels | 2 | Same |
| Analyte | Glucose | Same |
| Glucose (% w/v) I | 0.08%(1) | 0.07% |
| Glucose (% w/v) II | 0.15%(1) | Same |
| Target Range<br>(mg/dL) I | 88 - 136(2) | Same(3) |
| Target Range<br>(mg/dL) II | 174 - 269(2) | 179 - 275(3) |
| Container | Plastic bottle with dropper-tip | Same |
| Fill Volume | 4.0 mL | 3.6 mL |
| Color | Red | Same |
| Matrix | Viscosity-adjusted, aqueous<br>glucose control solution of D-<br>glucose and other non-reactive<br>ingredients | Buffered aqueous solution of D-<br>Glucose, a viscosity modifier,<br>preservatives, and other non-<br>reactive ingredients |
| Indications for Use | To validate the performance of<br>the blood glucose monitoring<br>system. | To check that the meter and test<br>strips are working together<br>properly. |
| Target Population | Professional and home use | Same |

### Comparison to Predicate Devices:

(1)Based data presented in k091914 Decision Summary

(2)Derived from the control ranges assigned by the manufacturer

(3)Based on a +/- 5% glucose concentration variability lot-to-lot and ± 20% range

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℃.

Open Vial Stability: A number of test and control vials was evaluated for 13 weeks. Each day all test group vials were opened, allowed to stand for ten minutes, then closed and stored at room temperature. Each week one test group vial and one control group vial was assayed in triplicate using the ACE Glucose assay. 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°C.

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510(k) Premarket Notification: FDI Glucose Controls for the Embrace No Code Fujirebio Diagnostics, Inc.

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 Embrace No Code monitor using three different lots of test strips, 10 replicates per strip lot, over three days. Range of acceptable values for each level is determined by calculating ± 20% of each control lot's calculated mean for three lots of strips. Acceptable ranges are based on predetermined acceptance criteria 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: Each control is traceable to a 70 mg/dL (Low) and a 150 mg/dL (High) in-house Standard traceable to the NIST Standard Reference Material 917. The in-house Standards are produced using SRM917.

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling a human figure with outstretched arms, possibly representing health, well-being, and service.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

January 17, 2014

FUJIREBIO DIAGNOSTICS, INC. KENT PRUETT DIRECTOR OF QUALITY/REGULATORY AFFAIRS 940 CROSSROADS BLVD SEGUIN TX 78155

Re: K133197

Trade/Device Name: FDI Level I and Level II Glucose Controls For The Embrace No Code Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: October 29, 2013 Received: November 5, 2013

#### 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 or any I vithe 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); good manufacturing practice requirements medical device-rented ad relise of the) 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 regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Courtney H. Lias -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration .

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known)

# K133197

Device Name FDI Level I and Level II Glucose Controls for the Embrace No Code

#### Indications for Use (Describe)

The FDI Glucose Controls are intended for use with Embrace No Code blood glucose meter and test strips. The controls are used to check that the meter and test strips are working together properly. I

The FDI Glucose Controls for the Embrace No Code are intended for use by healthcare professionals and people with diabetes mellitus at home.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

. :: FOR FDA USE ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : ...

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Stayce Beck

FORM FDA 3881 (9/13)