LIBERTY GLUCOSE CONTROL SOLUTION

K060481 · Liberty Healthcare Group, Inc. · JJX · Mar 9, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060481
• Device Name: LIBERTY GLUCOSE CONTROL SOLUTION
• Applicant: Liberty Healthcare Group, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Liberty Glucose Control 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 TheraSense FreeStyle Blood Glucose System.

Device Story

Liberty Glucose Control is an aqueous liquid control solution containing a known quantity of D-Glucose; used to verify performance of TheraSense FreeStyle Blood Glucose Monitor. Product is non-hazardous; contains no human or animal-derived materials; packaged in plastic dropper-tipped bottles. Red coloration added to assist user in visual confirmation of application to test strips. Used by healthcare professionals and patients in home settings. User applies control solution to test strip; monitor provides reading; user compares reading against expected range provided in product insert to ensure system accuracy.

Clinical Evidence

No clinical data. Bench testing only. Stability determined via Arrhenius model (accelerated) and real-time studies. Expected values established via repeat testing on TheraSense FreeStyle glucose monitor.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifier, preservatives, and non-reactive ingredients. Packaged in plastic dropper-tipped bottles. Non-hazardous. No human/animal-derived materials. Stability testing per CLSI EP5-A.

Indications for Use

Indicated for healthcare professionals and home users with diabetes mellitus to assess the performance of the TheraSense FreeStyle Blood Glucose 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.

Predicate Devices

• TheraSense FreeStyle Control (k031260)
• Liberty Glucose Control (k052980)

Submission Summary (Full Text)

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K 060481

#### 2006 MAR 9

- 5. 510(k) Summary
MAR 9 2006

- Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand basis for a the 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 Glucose Control . Common Name: Single Analyte Control Solution, All Types (Assayed and Unassayed) Quality Control Material (assayed and unassayed). Classification Name: Classification: Class I per 21 CFR 862.1660 Product Code: 75 JJX Panel: Chemistry Predicate Devices: Name: TheraSense FreeStyle Control Manufacturer: TheraSense, Inc. 510(k) No.: K031260 Name: Liberty Glucose Control Manufacturer: Liberty Healthcare Group, Inc. 510(k) No.: K052980

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- Device Description: The Liberty Glucose Control consists of a viscosityadjusted, 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.
- Intended Use: The Liberty Glucose Control 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 TheraSense FreeStyle Blood Glucose Monitor.

## Comparison to Predicate Device:

| Characteristic/<br>Aspect | Predicate Device No. 1 | Predicate Device No. 2 | New Product |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Name | TheraSense FreeStyle<br>Control | Liberty Glucose Control | Liberty Glucose<br>Control |
| 510(k), Date | K031260, 12/19/2003 | K052980 11/30/2005 | |
| Number of<br>Levels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Container | Plastic bottle with<br>dropper-tip | Plastic bottle with dropper<br>tip | Plastic bottle with<br>dropper tip |
| Fill Volume | 4.0 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red |
| Matrix | Buffered aqueous<br>solution of D-Glucose,<br>viscosity modifier,<br>preservatives, and other<br>non-reactive ingredients | Buffered aqueous<br>solution of D-Glucose, a<br>viscosity modifier,<br>preservatives, and other<br>non-reactive ingredients | Buffered aqueous<br>solution of D-Glucose, a<br>viscosity modifier,<br>preservatives, and<br>other non-reactive<br>ingredients |
| Indications for<br>Use | To use with FreeStyle<br>Blood Glucose<br>Monitoring System for<br>quality control purposes<br>to verify that the<br>FreeStyle Meter and<br>Test Strips are working<br>right. | Used to check the<br>performance of<br>Medisense Blood<br>Glucose Systems only. | Used to check the<br>performance of<br>FreeStyle Blood<br>Glucose Systems. |
| Target<br>Population | Professional and home<br>use | Professional and home<br>use | Professional and<br>home use |

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

#### 6. Truthful and Accuracy Statement

、

This section contains the Truthful and Accurate Statement.

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Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

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

Re: k060481 Trade/Device Name: Liberty Glucose Control Regulation Number: 21 CFR& 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: February 14, 2006 Received: February 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).

2006 MAR 9

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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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# Indications for Use

510(k) Number (if known): K060481

Device Name: Liberty 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 TheraSense FreeStyle Blood Glucose System.

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

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

Carol Benam
Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

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510(K) <060481