LIBERTY NORMAL GLUCOSE CONTROL SOLUTION

K060706 · Liberty Healthcare Group, Inc. · JJX · Apr 28, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060706
• Device Name: LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
• Applicant: Liberty Healthcare Group, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The Liberty Normal Glucose Control is intended for in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia Microfill, the Roche Accu-chek Active and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

Device Story

Liberty Normal Glucose Control is an in vitro diagnostic quality control solution; used to verify performance of specific blood glucose monitors (Roche Accu-check Active, Bayer Ascensia Microfill, LifeScan OneTouch Ultra, FastTake). Solution contains water, glucose, viscosity modifier, and preservatives; formulated to mimic whole blood properties without human-derived materials. Used by healthcare professionals or patients at home; applied to test strips in place of blood samples. Output is a qualitative/quantitative check of monitor accuracy against assigned ranges. Benefits patient by ensuring blood glucose monitor reliability and accuracy for diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Stability established via accelerated (Arrhenius model) and real-time studies; shelf life 24 months (≤5% loss). Open vial stability 90 days. Expected value ranges established for compatible monitors using three lots of strips in replicates of 10.

Technological Characteristics

Buffered aqueous solution containing D-glucose, viscosity modifiers, and preservatives. Non-biological, non-human derived. Packaged in plastic bottles with dropper-tips. Stability validated per CLSI EP5-A. Traceable to in-house glucose preparation.

Indications for Use

Indicated for use by healthcare professionals and people with diabetes mellitus to assess the performance of specific blood glucose monitors (Roche Accu-check Active, Bayer Ascensia Microfill, LifeScan OneTouch Ultra, and FastTake).

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

• OneTouch Ultra Control Solution (K001427)
• Ascensia Microfill Control Solution (K023657)
• Accu-chek Active Control High Level (K011738)
• 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:
k060706

B. Purpose for Submission:
New Device

C. Measurand:
Control material for glucose

D. Type of Test:
Not applicable

E. Applicant:
American Biological Technologies, Inc.

F. Proprietary and Established Names:
Liberty Normal Glucose Control

G. Regulatory Information:
1. Regulation section:
21 CFR§ 862.1660
2. Classification:
Class I, reserved
3. Product code:
JJX, single (specified) analyte controls (assayed and unassayed)
4. Panel:
Clinical Chemistry (75)

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H. Intended Use:

1. Intended use(s):

The Liberty Normal Glucose Control is intended for in vitro diagnostic use (i.e. for external use only) by health care professionals and in the home by people with diabetes mellitus to assess the performance of the Roche Accu-check Active, the Bayer Ascensia Microfill, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

2. Indication(s) for use:

See Intended use above.

3. Special conditions for use statement(s):

Over-The Counter Use

4. Special instrument requirements:

For use with Roche Accu-check Active, the Bayer Ascensia Microfill, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

I. Device Description:

The Liberty Glucose control contains water, glucose, a viscosity modifier, preservatives, and other non-reactive ingredients. The solution is formulated to act like a whole blood sample. The solution does not contain any human-derived or biological materials.

J. Substantial Equivalence Information:

1. Predicate device name(s):

#1--Ascensia Microfill control Solution

#2--Accu-Check Active Control High level

#3--Liberty Glucose Control

2. Predicate 510(k) number(s):

k023657

k011738

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k052980

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicates |
| | Liberty Normal Glucose Control | #1-k023657 #2-k011738 #3-k052980 |
| Number of levels | 1 level | #1,3 --1 level |
| Analytes | Glucose | #1,2,3—Glucose |
| Container | Plastic Bottle with dropper-tip | #1,2,3--Plastic Bottle with dropper-tip |
| Fill Volume | 3.6ml | #3--3.6 ml |
| Color | Red | #1,2,3—red |
| Matrix | Buffered aqueous solution of D-Glucose, viscosity modifiers, preservatives and other non-reactive ingredients | #1,2,3-- Buffered aqueous solution of D-Glucose, viscosity modifiers, preservatives and other non-reactive ingredients |
| Indications for use | Used to check the performance of Lifescan One-Touch Ultra and Fastake Blood Glucose Monitors, and Accu-check Active, and Ascensia Microfill blood glucose Systems | #1—For use with the Ascensia contour Blood Glucose meter and the Ascensia Microfill Test Strips as a quality control Check #2-- Used to perform quality control checks to ensure that the Accucheck Active System is working properly and that the blood glucose results are reliable |
| Target Population | Professional and home use | #1,2,3—Professional and home use |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Liberty Normal Glucose Control | #1-k023657 #2-k011738 #3-k052980 |
| Number of levels | 1 level | #2 - 2 levels |
| Fill volume | 3.6ml | #1—2.5ml #2 - 4ml |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Buffered aqueous solution of D-Glucose, viscosity modifiers, preservatives and other non-reactive ingredients | #2
Buffered solution containing Glucose, preservative and a thickening agent |
| Indications for Use | Used to check the performance of Accu-check Active, and Ascensia Microfill blood glucose Systems | #3
Used to check the performance of Medisense Blood Glucose Systems only |

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

CLSI EP5-A, Evaluation of the Precision Performance of Quantitative Measurement Methods

## L. Test Principle:

Not Applicable

## M. Performance Characteristics (if/when applicable):

1. Analytical performance:

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.

The stability of the product was determined by accelerated and real-time stability studies. Accelerated studies were performed at 37, 45 and 56 °C. Using the Arrhenius model, the results indicated shelf life stability for 24 months according to the sponsor’s criterion of ≤ 5 % loss. Real time studies are on-going to confirm accelerated findings. The open vial stability was determined by testing simulated use of opening vial for 10 minutes then closed. The results indicated open vial stability for 90 days according to the sponsor’s criterion of ≤ 5 % loss from day 1.

The expected values for the monitors were determined by testing three lots of strips in replicates of 10. The mean, standard deviation and % CV were

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obtained for each monitor. Analysis of the data resulted in assigned ranges of the following $\pm\%$ of the calculated mean:

Roche Accu-check Active - $\pm 14.5\%$

Bayer Ascensia Microfill - $\pm 12\%$

LifeScan OneTouch Ultra - $\pm 17\%$

LifeScan FastTake - $\pm 18\%$

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

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:

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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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