LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047

K063855 · Liberty Healthcare Group, Inc. · JJX · Feb 1, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063855
• Device Name: LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047
• Applicant: Liberty Healthcare Group, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Feb 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Liberty Control Solutions are intended for in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Liberty Blood Glucose Monitoring System.

Device Story

Liberty Control Solutions are viscosity-adjusted, aqueous liquid controls containing known quantities of glucose; packaged in plastic dropper-tipped bottles. Used by healthcare professionals and patients with diabetes mellitus in clinical or home settings to verify the accuracy and performance of the Liberty Blood Glucose Monitoring System. The solution contains a red dye to assist users in visually confirming application to test strips. The device is non-hazardous and contains no human or animal-derived materials. Users apply the control solution to a test strip; the glucose monitoring system measures the glucose level; the user compares the result against expected ranges to ensure the system is functioning correctly.

Clinical Evidence

No clinical data. Bench testing only. Stability determined via real-time studies (24-month shelf-life, 90-day open-vial stability). Traceability established via in-house glucose preparation; acceptable ranges assigned via repeat analysis using three lots of test strips.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifier, preservatives, and red dye. Packaged in plastic dropper-tipped bottle. Non-sterile. Evaluated per CLSI EP5-A for precision performance. No human or animal-derived materials.

Indications for Use

Indicated for in vitro diagnostic use by healthcare professionals and individuals with diabetes mellitus to verify the performance of the Liberty 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.

Predicate Devices

• AgaMatrix Liberty Control Solutions (Normal and High Levels) (K052762)
• Liberty Glucose Control (K052980)

Submission Summary (Full Text)

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K063855

FEB - I 2007

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

- ડ. 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.

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 Control Solutions (Normal Level and High Level)

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

Name:

Product Code: 75 JJX

Panel: Chemistry

Predicate Devices:

Manufacturer: 510(k) No.:

AqaMatrix Liberty Control Solutions (Normal level and High level) AgaMatrix, Inc. K052762

Name: Liberty Glucose Control Manufacturer: Liberty Healthcare Group, Inc. 510(k) No .: K052980

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

- The Liberty Control Solutions consist of a viscosity-Device Description: adjusted, aqueous liquid control solution containing known quantities of glucose. They are 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.
- The Liberty Control Solutions are intended for in vitro Intended Use: diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Liberty Blood Glucose Monitoring System.

## Comparison to Predicate Device:

| Characteristic/<br>Aspect | Predicate Device No.<br>1 | Predicate Device<br>No. 2 | New Product |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Name | AgaMatrix Liberty<br>Control Solutions<br>(Normal and High<br>Levels) | Liberty Glucose<br>Control | Liberty Control<br>Solutions (Normal<br>and High Levels) |
| 510(k), Date<br>Number of Levels | K052762, 01/23/2006<br>2 | K052980,11/30/2005<br>1 | 2 |
| Analytes | Glucose | Glucose | Glucose |
| Container | Plastic bottle with<br>dropper-tip | Plastic bottle with<br>dropper tip | Plastic bottle with<br>dropper tip |
| Fill Volume | 6 mL | 3.6 mL | 3.6 mL |
| Color | Blue | Red | Red |
| Matrix | Buffered aqueous<br>solution of D-Glucose,<br>viscosity modifier,<br>preservatives, and<br>other non-reactive<br>ingredients | Buffered aqueous<br>solution of D-<br>Glucose, viscosity<br>modifiers.<br>preservatives, and<br>other non-reactive<br>ingredients | Buffered aqueous<br>solutions of D-<br>Glucose, viscosity<br>modifiers,<br>preservatives, and<br>other non-reactive<br>ingredients |
| Indications for Use | Used with the Liberty<br>Meter and Test Strips<br>as a quality control<br>check to verify the<br>accuracy of blood<br>glucose test results. | Used to check the<br>performance of<br>Medisense Blood<br>Glucose Systems<br>only. | Used to check the<br>performance of<br>Liberty Blood<br>Glucose Monitoring<br>System. |
| Target Population | Professional and<br>home use | Professional and<br>home use | Professional and<br>home use |

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

## Performance Studies: Tests were performed to verify specific performance characteristics:

- 1. Stability
- 2. Open Vial Stability
- 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Liberty Healthcare Group, Inc. FEB - 1 2007 John C Gormley c/o Americal Biological Technologies, Inc. 940 Crossroads Blvd. Seguin, TX 78155

Re: k063855

Trade Name: Liberty Control Solutions (Normal Level and High Level) Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I Product Code: JJX Dated: December 27, 2006 Received: December 28, 2006

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 tolla the north ne [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean m. Cooper, M.S., D.v.M.

Yéan M. Cooper, M.S., D.V.M. 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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510(k) Premarket Notification: Liberty Control Solutions American Biological Technologies, Inc.

## Indications for Use Statement বঁ

510(k) Number (if known): K063655

Device Name: Liberty Control Solutions (Normal Level and High Level)

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 Liberty Blood Glucose Monitoring System ..

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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)

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