LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041

K060426 · Liberty Healthcare Group, Inc. · JJX · Mar 9, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060426
• Device Name: LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
• 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
• Attributes: Pediatric

Intended Use

The Liberty Glucose Normal Control Solution 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 Bayer Ascensia DEX 2/DEX and BREEZE Blood Glucose Monitors.

Device Story

Liberty Glucose Normal Control Solution is an in vitro diagnostic quality control material used to verify the performance of Bayer Ascensia DEX 2/DEX and Breeze Blood Glucose Monitors. The device consists of a viscosity-adjusted, aqueous liquid containing a known quantity of D-Glucose, preservatives, and a red dye for visual confirmation of application. It is packaged in plastic dropper-tipped bottles for manual application to test strips. Used by healthcare professionals and patients with diabetes in clinical or home settings. The user applies the solution to a test strip; the monitor provides a reading which is compared against the expected range provided in the product insert to ensure system accuracy. The device contains no human or animal-derived materials.

Clinical Evidence

No clinical data. Bench testing only. Stability determined via Arrhenius model (accelerated) and real-time studies; open vial stability established at 90 days (2-30 °C). Expected values determined by repeat testing on target glucose monitors.

Technological Characteristics

Viscosity-adjusted, aqueous liquid control solution containing D-Glucose, viscosity modifiers, preservatives, and non-reactive ingredients. Red colorant added. Packaged in plastic dropper-tipped bottles. Non-hazardous; contains no human or animal-derived materials.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to assess the performance of Bayer Ascensia DEX 2/DEX and BREEZE Blood Glucose Monitors via in vitro diagnostic testing.

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

• Bayer Ascensia Autodisc Normal Control (k963500)
• Liberty Glucose Control (k052980)

Submission Summary (Full Text)

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

K060426

#### 2006 MAR Y

- 5. 510(k) Summary

| 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: | Liberty Healthcare Group, Inc.<br>8883 Liberty Lane<br>Port St. Luce, FL 34952 | | |
| Contact Person: | John C. Gormley<br>American Biological Technologies, Inc.<br>940 Crossroads Blvd<br>Seguin, TX 78155<br>[phone] ex. 210<br>Establishment Registration Number: 1643621 | | |
| Device Name: | Liberty Glucose Normal Control Solution | | |
| 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 | | |
| Product Code: | 75 JJX | | |
| Panel: | Chemistry | | |
| Predicate Devices: | Name: | Bayer Ascensia AUTODISC Normal<br>Control | |
| | Manufacturer: | Bayer Healthcare, LLC. | |
| | 510(k) No.: | K963500 | |

Page 12 of 43

Name:

Manufacturer:

510(k) No.:

Liberty Glucose Control

K052980

Liberty Healthcare Group

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

- Device Description: The Liberty Glucose Normal Control Solution 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 nonhazardous and contains no human or animal derived materials.
- Intended Use: The Liberty Glucose Normal Control Solution 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 Bayer Ascensia DEX 2/DEX and BREEZE Blood Glucose Monitors.

## Comparison to Predicate Device:

| Characteristic/<br>Aspect | Predicate Device No. 1 | Predicate Device No. 2 | New Product |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Name | Ascensia AUTODISC Normal<br>Control | Liberty Glucose Control | Liberty Glucose<br>Normal Control<br>Solution |
| 510(k), Date | K963500, 01/21/1997 | K052980 11/30/2005 | |
| Number of<br>Levels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Container | Plastic bottle with dropper-<br>tip | Plastic bottle with<br>dropper-tip | Plastic bottle with<br>dropper-tip |
| Fill Volume | 2.5 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red |
| Matrix | Red solution containing a<br>measured amount of<br>glucose. | Buffered aqueous<br>solution of D-Glucose,<br>viscosity modifiers,<br>preservatives, and other<br>non-reactive ingredients | Buffered aqueous<br>solution of D-Glucose,<br>viscosity modifiers,<br>preservatives, and<br>other non-reactive<br>ingredients |
| Indications for<br>Use | For use with an appropriate<br>Ascensia/Glucometer Blood<br>Glucose Meter and<br>Ascensia AUTODISC Test<br>Strip Disc as a quality<br>control check to verify the<br>accuracy of blood glucose<br>test results. | Used to check the<br>performance of<br>Medisense Blood<br>Glucose Systems only. | To check the<br>performance of the<br>Bayer Ascensia DEX<br>2/DEX and BREEZE<br>Blood Glucose<br>Monitors. |
| Target<br>Population | Professional and home use | Professional and home<br>use | Professional and<br>home use |

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

#### 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/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.

Public Health Service

Food and Drug Administrati 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, Texas 78155

Re: k060426

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

DEPARTMENT OF HEALTH & HUMAN

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 Gutt

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): K060426

Device Name: Liberty Glucose Normal Control Solution

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 Bayer Ascensia DEX 2/DEX and BREEZE Blood Glucose Monitors.

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 Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) k060426