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

Indications for 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) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k060426

B. Purpose for Submission:
Notification of intent to manufacture and market the device: Liberty Glucose Normal Control Solution for the Bayer Ascensia DEX 2/DEX and Breeze Glucose Monitors

C. Measurand:
Glucose

D. Type of Test:
Quality Control Material

E. Applicant:
Liberty Healthcare Group, Inc

F. Proprietary and Established Names:
Liberty Glucose Normal Control Solution

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660
2. Classification:
Class I
3. Product code:
JJX, single (specified) analyte controls (assayed and unassayed)

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4. Panel:
75, Chemistry

H. Intended Use:

1. Intended use(s):
See indication for use below.

2. Indication(s) for use:
Liberty Glucose Normal Control Solution is 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.

3. Special conditions for use statement(s):
Over the Counter use

4. Special instrument requirements:
Bayer Ascensia DEX 2/DEX and Breeze Blood Glucose Monitors

I. Device Description:

The Liberty Glucose Normal Control Solution consists of a viscosity-adjusted, aqueous liquid containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solution to the test strips. A red coloration is present to aid the user visually in confirming the application of the control. The product is non-hazardous and contains no human or animal derived materials.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Bayer Ascensia Autodisc Normal Control and Liberty Glucose Control

2. Predicate 510(k) number(s):
k963500 and k052980, respectively

3. Comparison with predicate:

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| Characteristic/Aspect | Ascensia Autodisc Normal Control (predicate device) | Liberty Glucose Control (predicate device) | Liberty Glucose Normal Control Solution |
| --- | --- | --- | --- |
| 510(k) | k963500 | k052980 | |
| Number of levels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Container | Plastic bottle with dropper tip | Plastic bottle with dropper tip | Plastic bottle with dropper tip |
| Fill volume | 2.5 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red |
| Matrix | Red solutions containing a measured amount of Glucose | Buffered aqueous solution of D-Glucose, viscosity modifiers, preservatives and other non-reactive ingredients | Buffered aqueous solution of D-Glucose, viscosity modifiers, preservatives and other non-reactive ingredients |
| Indications for use | For use with the appropriate Ascensia/Glucometer Blood Glucose meter and Ascensia Autodisc Test strip Disc as a quality control check to verify the accuracy of blood glucose test results. | Used to check the performance of Medisense Blood Glucose Systems only. | To check the performance of the Bayer Ascensia DEX and 2/DEX and Breeze Blood Glucose Monitors |
| Target Population | Professional and Home use | Professional and Home use | Professional and Home use |

K. Standard/Guidance Document Referenced (if applicable):

CLSI EP5-A, Evaluation of the Precision Performance of Clinical Chemistry Devices.

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

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a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The D-Glucose used in this control is traceable to an in-house glucose preparation. Stability characteristics of the Liberty Glucose Control were determined using the Arrhenius model of accelerated elevated temperature and real time studies to determine estimated storage stability at 2 – 30 °C. Open vial stability was determined to be 90 days at 2-30 °C.

The expected values were determined by repeat testing on each glucose monitor (Bayer Ascensia DEX 2/DEX and Breeze). Statistical analysis of the data obtained resulted in one range for the three glucose monitors. The expected results may change with each new lot, but the control range is listed in the product insert. In addition, the product insert alerts the user to use the control range indicated in the control’s product insert rather than the glucose test strip product’s insert.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:

Not applicable

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3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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