LIBERTY GLUCOSE CONTROL, MODEL 2120031

K052980 · Liberty Healthcare Group, Inc. · JJX · Nov 30, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052980
• Device Name: LIBERTY GLUCOSE CONTROL, MODEL 2120031
• Applicant: Liberty Healthcare Group, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Liberty Glucose Control MID 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 Abbott Medisense Optium, Precision, Precision 3, and Precision Xtra Blood Glucose Monitors.

Device Story

Liberty Glucose Control MID is a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. Packaged in plastic dropper-tipped bottles, it includes a red dye to assist users in visually confirming application to test strips. Used by healthcare professionals and patients with diabetes in clinical or home settings to verify the performance of Abbott Medisense Optium, Precision, Precision 3, and Precision Xtra Blood Glucose Monitors. The solution is non-hazardous and contains no human or animal-derived materials. Users apply the control to test strips as they would a blood sample; the monitor provides a reading that the user compares against the expected range to ensure system accuracy.

Clinical Evidence

Bench testing only. Performance studies included accelerated and real-time stability testing, open vial stability, microbial stress stability, and test precision.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifier, preservatives, and red colorant. Packaged in plastic dropper-tipped bottles. Non-hazardous; no human or animal-derived materials. Standalone liquid control material.

Indications for Use

Indicated for healthcare professionals and home users with diabetes mellitus to assess the performance of specific Abbott Medisense blood glucose monitoring systems.

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

• Precision Control Solutions (K983504)

Submission Summary (Full Text)

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NOV 3 0 2005

## K05 2980 5. 510(k) Summary

- According to the requirements of 21 CFR 807.92, the Introduction: following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
- Liberty Healthcare Group, Inc. Submitter: 10045 S. Federal Highway Port St. Luce, FL 34952
- John C. Gormley Contact Person: American Biological Technologies, Inc. 940 Crossroads Blvd Sequin, TX 78155 [phone] ex. 210 Establishment Registration Number: 1643621
- Liberty Glucose Control MID Device Name:
- Single Analyte Control Solution, All Types (Assayed and Common Name: Unassayed)
- Quality Control Material (assayed and unassayed). Classification Name:
- Class I per 21 CFR 862.1660 Classification:
- Product Code: 75 JJX

Panel: Chemistry

Predicate Device: Name: Precision Control Solutions Manufacturer: Abbott Laboratories, Inc. Medisense Products K983504 510(k) No.:

The Liberty Glucose Control MID consists of a viscosity-Device Description: adjusted, aqueous liquid control solution containing a known quantity of qlucose. 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 materials.

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- The Liberty Glucose Control MID is intended for in vitro Intended Use: 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 Abbott Medisense Optium, Precision, Precision 3, and Precision Xtra Blood Glucose Monitors.
## Comparison to Predicate Device:

| Characteristic/<br>Aspect | Predicate Device | New Product |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Name | Precision Control Solutions | Liberty Glucose Control MID |
| 510(k), Date | K983504, 07/09/1999 | |
| Number of<br>Levels | 1 | 1 |
| Analytes | Glucose/ β-Ketone | Glucose |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper tip |
| Fill Volume | 3 mL | 3.6 mL |
| Color | N/A | Red |
| Matrix | Buffered aqueous solution of D-Glucose<br>and β-hydroxybutyrate, viscosity modifier,<br>preservatives, and other non-reactive<br>ingredients | Buffered aqueous solution of D-<br>Glucose, viscosity modifier,<br>preservatives, and other non-<br>reactive ingredients |
| Indications for<br>Use | Used to check the performance of<br>Medisense Blood Glucose and β -Ketone<br>Systems and can be used for either<br>glucose or ketone determinations | Used to check the performance<br>of Medisense Blood Glucose<br>Systems only. |
| Target<br>Population | Professional and home use | Professional and home 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
- Comparison of the performance characteristics, formulation Conclusion: use support the claim of substantial and intended equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem. The seal is presented in black and white, giving it a formal and official appearance.

Public Health Service

NOV 3 0 2005

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

Re: k052980

Trade/Device Name: Liberty Glucose Control MID Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: October 20, 2005 Received: October 24, 2005

Dear Mr. Gormley:

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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Page 2 -

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 G
Alberto Gutierrez, Ph.D.

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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4. Indications for Use Statement
510(k) Number K052980

Liberty Glucose Control MID Device Name:

Indications for Use:

For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in I of in Vitto diagnound abo (nor or exellitus to assess the performance of the Medisense the home by poople man alabs 3, and Precision Xtra Blood Glucose Monitors.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K052980