ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087

K091460 · American Biological Technologies, Inc. · JJX · Aug 6, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091460
• Device Name: ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
• Applicant: American Biological Technologies, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The AbT Glucose Control Solutions are 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 the TRUEresult™ and TRUE2go™ Meters and TRUEtest™ Test Strips.

Device Story

AbT Glucose Control Solutions are buffered aqueous solutions containing D-Glucose, viscosity modifiers, preservatives, and red dye; used as quality control material for blood glucose monitoring systems. The device is intended for use by healthcare professionals and patients with diabetes in clinical or home settings. Users apply the control solution to a test strip; the meter measures the glucose concentration. The output is a quantitative glucose value displayed on the meter, which the user compares against the expected range printed on the control vial label. This process verifies the performance of the meter and test strip system, ensuring accurate glucose monitoring for the patient.

Clinical Evidence

No clinical data. Bench testing only. Stability established via accelerated shelf-life and open-vial studies (90 days). Traceability established via NIST SRM 917b. Expected values determined using reference clinical chemistry analyzers and TRUEresult monitors with TRUEtest strips.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifiers, salts, dyes, and preservatives. Non-sterile, non-hazardous. Packaged in plastic dropper-tipped bottles. No human or animal-derived materials. Standard: CLSI EP5-A2 for precision evaluation.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to assess the performance of TRUEresult and TRUE2go meters and TRUEtest test strips.

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

• TRUEtest Glucose Controls Levels 1, 2, 3 (k080641)

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
k091460

B. Purpose for Submission:
New device

C. Measurand:
Control materials for glucose test systems

D. Type of Test:
Quantitative

E. Applicant:
American Biological Technologies, Inc.

F. Proprietary and Established Names:
AbT Glucose Control Solutions Levels 1, 2, 3

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:

{1}

Clinical Chemistry

## H. Intended Use:

1. Intended use(s):

Refer to indications 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 TRUEresult™ and TRUE2go™ Meters and TRUEtest™ Test Strips.

3. Special conditions for use statement(s):

For *in vitro* diagnostic use (for external use only). For over the counter use.

4. Special instrument requirements:

TRUEresult and TRUE2go blood glucose test systems

## I. Device Description:

The AbT Glucose Control Solutions consist of buffered aqueous solutions of D-Glucose, a viscosity modifier, preservatives, red dye, and other non-reactive ingredients. The devices are non-sterile, non-hazardous, and contain no human or animal derived materials. The product is packaged in plastic dropper tipped bottles for easy application to the test strip and contains a red coloration to aid the user to visually confirm application of the control.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

TRUEtest Glucose Controls Levels 1, 2, 3

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

k080641

3. Comparison with predicate:

| Comparison Table | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Name | AbT Glucose Control | TRUEtest Glucose |

{2}

| Comparison Table | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | Control |
| Number of Levels | 3 | 3 |
| Analyte | Glucose | Glucose |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Color | Red | Red |
| Fill Volume | 3.0 mL | 3.6 mL |
| Matrix | Water, D-glucose, buffers, viscosity enhancing agents, salts, dyes, and preservatives | Buffered aqueous solution of D-glucose, a viscosity modifier, preservatives, and other non-reactive ingredients |
| Intended Use | The AbT Glucose Control Solution is intended for use with TRUEresult™ and TRUE2go™ blood glucose systems using TRUEtest™ test strips. It is used to check their performance. | TRUEtest Glucose Control is a red liquid containing a known amount of glucose. Use Control with TRUE2go™ and TRUEresult™ Meters and TRUEtest™ Test Strips. |
| Target Population | Prescription and home use | Prescription and home use |

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

CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods, Second Edition 08/2004

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

{3}

Not applicable

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

**Traceability**

The D-glucose used in these controls is traceable to an in-house standard prepared from NIST Standard Reference Material 917b. The control material is analyzed on the sponsor’s reference analyzer and recovered values must fall within acceptance criteria based on the target value of the NIST standard.

**Expected Values**

Glucose controls expected values were determined by repeat analyses using the sponsor’s reference clinical chemistry analyzer. Pre-determined acceptance criteria for glucose recovery must be met for each control lot. Acceptable ranges for the glucose values were determined using a TRUEresult monitor and three different lots of TRUEtest strips, ten replicates per strip lot, over three days. Glucose control value ranges are lot dependent and are listed in the control vial label for each lot. Test results must fall within the range printed on the control vial. These ranges may differ from the range printed on the test strip vial.

**Stability**

Stability characteristics of the AbT Glucose Control Solutions were determined using accelerated shelf-life studies and open vial studies. An unopened shelf-life of 24 months is expected at the recommended storage temperature of 36°F to 86°F. Open vial stability of 90 days was demonstrated when controls were stored at room temperature.

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:

{4}

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:

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.