LIBERTY NORMAL GLUCOSE CONTROL SOLUTION

K060706 · Liberty Healthcare Group, Inc. · JJX · Apr 28, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060706
• Device Name: LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
• Applicant: Liberty Healthcare Group, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Liberty Normal Glucose Control is intended for in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia Microfill, the Roche Accu-chek Active and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

Device Story

Liberty Normal Glucose Control is an in vitro diagnostic quality control solution; used to verify performance of specific blood glucose monitors (Roche Accu-check Active, Bayer Ascensia Microfill, LifeScan OneTouch Ultra, FastTake). Solution contains water, glucose, viscosity modifier, and preservatives; formulated to mimic whole blood properties without human-derived materials. Used by healthcare professionals or patients at home; applied to test strips in place of blood samples. Output is a qualitative/quantitative check of monitor accuracy against assigned ranges. Benefits patient by ensuring blood glucose monitor reliability and accuracy for diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Stability established via accelerated (Arrhenius model) and real-time studies; shelf life 24 months (≤5% loss). Open vial stability 90 days. Expected value ranges established for compatible monitors using three lots of strips in replicates of 10.

Technological Characteristics

Buffered aqueous solution containing D-glucose, viscosity modifiers, and preservatives. Non-biological, non-human derived. Packaged in plastic bottles with dropper-tips. Stability validated per CLSI EP5-A. Traceable to in-house glucose preparation.

Indications for Use

Indicated for use by healthcare professionals and people with diabetes mellitus to assess the performance of specific blood glucose monitors (Roche Accu-check Active, Bayer Ascensia Microfill, LifeScan OneTouch Ultra, and FastTake).

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

• OneTouch Ultra Control Solution (K001427)
• Ascensia Microfill Control Solution (K023657)
• Accu-chek Active Control High Level (K011738)
• Liberty Glucose Control (K052980)

Submission Summary (Full Text)

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Ka60706

#### 5. 510(k) Summary

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| 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: | Liberty Healthcare Group, Inc. 8883 Liberty Lane Port St. Luce, FL 34952 |
| Contact Person: | John C. Gormley American Biological Technologies, Inc. 940 Crossroads Blvd Seguin, TX 78155 [phone] ex. 210 Establishment Registration Number: 1643621 |
| Device Name: | Liberty Normal Glucose Control |
| 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: | OneTouch Ultra Control Solution |
|---------------|---------------------------------|
| Manufacturer: | LifeScan, Inc. |
| 510(k) No.: | K001427 |

| Name: | Ascensia Microfill Control Solution |
|---------------|-------------------------------------|
| Manufacturer: | Bayer Healthcare |
| 510(k) No.: | K023657 |

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| Name: | Accu-chek Active Control High Level |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer:<br>510(k) No.: | Roche Diagnostics Corporation<br>K011738 |
| Name:<br>Manufacturer:<br>510(k) No.: | Liberty Glucose Control<br>Liberty Healthcare Group, Inc.<br>K052980 |
| Device Description: | The Liberty Normal Glucose Control 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 non-hazardous and contains no human or animal derived |

- The Liberty Normal Glucose Control is intended for in Intended Use: vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia Microfill, the Roche Accu-chek Active and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
materials.

## Comparison to Predicate Device:

| Characteristic/<br>Aspect | Predicate<br>Device No. 1 | Predicate<br>Device No. 2 | Predicate<br>Device No. 3 | Predicate<br>Device No. 3 | New<br>Product |
|---------------------------|----------------------------------------|----------------------------------------------|----------------------------------------------|---------------------------------------|-----------------------------------------|
| Name | OneTouch<br>Ultra Control<br>Solution | Ascensia<br>Microfill<br>Control<br>Solution | Accu-chek<br>Active<br>Control High<br>Level | Liberty<br>Glucose<br>Control | Liberty<br>Normal<br>Glucose<br>Control |
| 510(k), Date | K001427,<br>06/02/2000 | K02367<br>05/12/2003 | K011738<br>06/20/2001 | K052980<br>11/30/2005 | |
| Number of<br>Levels | 1 | 1 | 2 | 1 | 1 |
| Analytes | Glucose | Glucose | Glucose | Glucose | Glucose |
| Container | Plastic bottle<br>with dropper-<br>tip | Plastic bottle<br>with dropper-<br>tip | Plastic bottle<br>with dropper-<br>tip | Plastic bottle<br>with dropper<br>tip | Plastic bottle<br>with dropper<br>tip |
| Fill Volume | 3 mL | 2.5 mL | 4 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | N/A | Red | Red |

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510(k) Premarket Notification: Liberty Normal Glucose Control American Biological Technologies, Inc.

| Characteristic/<br>Aspect | Predicate<br>Device No. 1 | Predicate<br>Device No. 2 | Predicate<br>Device No. 3 | Predicate<br>Device No. 3 | New<br>Product |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Buffered<br>aqueous<br>solution of D-<br>Glucose,<br>viscosity<br>modifier,<br>preservatives,<br>and other<br>non-reactive<br>ingredients | Buffered<br>aqueous<br>solution of D-<br>Glucose,<br>viscosity<br>modifier,<br>preservatives,<br>and other non-<br>reactive<br>ingredients | Buffered<br>aqueous<br>solution<br>containing<br>Glucose,<br>preservative<br>and a<br>thickening<br>agent. | Buffered<br>aqueous<br>solution of D-<br>Glucose,<br>viscosity<br>modifiers,<br>preservatives<br>, and other<br>non-reactive<br>ingredients | Buffered<br>aqueous<br>solution of<br>D-Glucose,<br>viscosity<br>modifiers,<br>preservative<br>s, and other<br>non-reactive<br>ingredients |
| Indications for<br>Use | Used with<br>OneTouch<br>Ultra Brand<br>Systems, The<br>OneTouch<br>FastTake<br>System,<br>InDuo Brand<br>Systems and<br>OneTouch<br>UltraSmart<br>Systems to<br>check that<br>the meter and<br>test strips are<br>working<br>together as a<br>system and<br>that the user<br>is performing<br>the test<br>correctly | For use with<br>the Ascensia<br>Contour Blood<br>Glucose Meter<br>and the<br>Ascensia<br>MICROFILL<br>Test Strips as<br>a quality<br>control check. | Used to<br>perform<br>quality<br>control<br>checks to<br>ensure that<br>the Accu-<br>chek Active<br>System is<br>working<br>properly and<br>that the blood<br>glucose<br>results are<br>reliable. | Used to<br>check the<br>performance<br>of Medisense<br>Blood<br>Glucose<br>Systems<br>only. | Used to<br>check the<br>performance<br>of<br>OneTouch<br>Ultra,<br>OneTouch<br>FastTake,<br>Accu-chek<br>Active, and<br>Ascensia<br>Microfill<br>Blood<br>Glucose<br>Systems. |
| Target<br>Population | Professional<br>and home<br>use | Professional<br>and home use | Professional<br>and home<br>use | Professional<br>and home<br>use | Professional<br>and home<br>use |

# Performance Studies:

Tests were performed to verify specific performance characteristics:

- 1. Stability (Accelerated and Real-time)
- 2. Open Vial
- 3. Microbial Stress Stability
- 4. Test precision

### Conclusion:

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

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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Liberty Healthcare Group, Inc. c/o Mr. John Gormley Vice President Quality Assurance/Regulatory Affairs American Biological Technologies, Inc. 940 Crossroads Blvd. Seguin, TX 78155

APR 2 8 2006

Re: k060706 Trade/Device Name: Liberty Normal Glucose Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: March 14, 2006 Received: March 23, 2006

Dear Mr. Gromley;

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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,

Alberto Gutz

Alberto Gutierrez, 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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#### র্বা Indications for Use Statement

510(k) Number (if known):

Device Name: Liberty Normal Glucose Control

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 Roche Accu-chek Active, the Bayer Ascensia Microfill, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 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)

AND/OR

C.A.C

C:
Date

51006 k060706

safety