ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089

K090943 · American Biological Technologies, Inc. · JJX · May 27, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090943
• Device Name: ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
• Applicant: American Biological Technologies, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The AbT Glucose Control Solution 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 WaveSense Presto Blood Glucose Monitoring System.

Device Story

AbT Glucose Control Solution is an aqueous, viscosity-adjusted liquid containing a known quantity of D-Glucose; packaged in a plastic dropper-tipped bottle. Used by healthcare professionals and patients with diabetes in clinical or home settings to verify the performance of the WaveSense Presto Blood Glucose Monitoring System. The user applies the solution to a test strip; the red-colored liquid provides visual confirmation of application. The device functions as a quality control material to ensure the meter and test strips are working together properly. It contains no human or animal-derived materials.

Clinical Evidence

No clinical data. Bench testing only. Stability determined via accelerated and real-time studies. Traceability established to NIST standard 917b. Value assignment performed using three lots of AgaMatrix WaveSense Presto test strips and one monitor.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifiers, and preservatives. Red-colored liquid. Packaged in plastic dropper-tipped bottle (3.6 mL fill volume). Non-hazardous; no human or animal-derived materials. Standalone quality control material.

Indications for Use

Indicated for healthcare professionals and home users with diabetes mellitus to assess the performance of the AgaMatrix WaveSense Presto 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

• WaveSense Normal Control Solution (k052762)
• Liberty Normal Control Solution (k063855)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k090943

B. Purpose for Submission:
New device

C. Measurand:
Quality control material for blood glucose monitoring system

D. Type of Test:
Quantitative

E. Applicant:
American Biological Technologies, Inc.

F. Proprietary and Established Names:
AbT Glucose Control Solution

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

H. Intended Use:
1. Intended use(s):
See indication for use below.
2. Indication(s) 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 Agamatrix WaveSense Presto Blood Glucose Monitor.
3. Special conditions for use statement(s):
For in vitro diagnostic use, over-the-counter use.
4. Special instrument requirements:
For use with the AgaMatrix WaveSense Presto Blood Glucose Monitor.

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I. Device Description:

The AbT Glucose Control Solution is a viscosity-adjusted, buffered aqueous control solution containing a known quantity of glucose. The product is packaged in a plastic dropper tipped bottle for easy application of the control solution to the test strips and contains red coloration to aid the user to visually confirm application. The product is nonhazardous and contains no human or animal derived materials.

J. Substantial Equivalence Information:

1. Predicate device name(s):

WaveSense Normal Control Solution, AgaMatrix, Inc.

Liberty Normal Control Solution, Liberty Healthcare Group, Inc.

2. Predicate K number(s):

k052762 and k063855 respectively.

3. Comparison with predicate:

| Item | Device | WaveSense Normal Control Solution | Liberty Normal control Solution |
| --- | --- | --- | --- |
| Similarities/Differences | | | |
| Intended Use | Used to check the performance of AgaMatrix WaveSense Presto Glucose Monitoring System | Used with the WaveSense-enabled Blood Glucose Meter and WaveSense Test Strips to ensure that the meter and test strips are working together properly | Used to check the performance of Liberty Blood Glucose Monitoring System. |
| Levels | 1 | same | same |
| Analyte | Glucose | same | same |
| Target | 95 – 145 mg/dL | 108 – 159 mg/dL (1) | 94 – 147 mg/dL (2) |
| Matrix | Buffered aqueous solution of D-Glucose, viscosity modifiers, preservatives, and other non-reactive ingredients | same | same |
| Container | Plastic bottle with dropper-tip | same | same |
| Fill Volume | 3.6 mL | 6 mL | 3.6 mL |
| Color | Red | Blue | Red |
| Target Population | Professional and home use | same | same |

(1) Estimated from WaveSense Presto test strip lots published ranges.
(2) Estimated from Liberty Normal Control Solution published control ranges.

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K. Standard/Guidance Document Referenced (if applicable):
Evaluation of the Precision Performance of Quantitative Measurement Methods;
Approved Guideline—Second Edition (CLSI EP5-A2).

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 which is traceable to the NIST standard 917b. Values are assigned by repeat analysis using three different lots of AgaMatrix WaveSense Presto test strips and one AgaMatrix WaveSense Presto Blood Glucose Monitor. The mean and standard deviation are used to establish the acceptable range for the AgaMatrix WaveSense Presto Blood Glucose Monitor.

Stability characteristics of the AbT Glucose Control Solution were determined using accelerated and real-time studies. The unopened shelf-life is 24 months and the open vial stability is 90 days at the recommended storage of 36 °F to 86 °F.

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: An acceptable range for the AbT glucose control used with the AgaMatrix WaveSense Presto blood glucose monitoring system is printed on the control vial label. When using this control material, users are to compare their control result to the range on the control vial (rather than the range printed on the test strip vial).

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