GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK

K081403 · Bionostics, Inc. · JJX · Jul 25, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081403
• Device Name: GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
• Applicant: Bionostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

Glucose Meter-Check" Solution is intended to assess the performance of the following Roche ACCU-CHEK blood glucose test systems: Roche ACCU-CHEK Advantage using Comfort Curve® test strips, Roche ACCU-CHEK Active®, Roche ACCU-CHEK Aviva®, Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus®. The Meter-Check Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use

Device Story

Glucose Meter-Check Control Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution; used to verify performance of Roche ACCU-CHEK blood glucose monitoring systems. The solution contains D-glucose at a concentration simulating normal fasting blood glucose levels; packaged in plastic bottles with dropper tips for application to test strips. The solution is red-colored to aid visibility during dispensing. Used by healthcare professionals and patients with diabetes mellitus in clinical or home settings. The user applies the solution to a test strip; the meter reads the strip; the user compares the result to the assigned range to verify system accuracy. Benefits include ensuring reliable blood glucose monitoring performance.

Clinical Evidence

No clinical data. Bench testing only. Stability established via real-time and accelerated studies (24-month closed bottle, 90-day open bottle) with <5% glucose concentration change. Value assignment performed using YSI 2300 reference method; target ranges calculated as mean ± 15%.

Technological Characteristics

Viscosity-adjusted, aqueous liquid control solution containing D-glucose. Non-hazardous; contains no human or animal-derived materials. Packaged in plastic bottles with dropper tips. Designed to simulate whole blood response on Roche ACCU-CHEK systems.

Indications for Use

Indicated for use by healthcare professionals and people with diabetes mellitus to assess the performance of Roche ACCU-CHEK blood glucose test systems (Aviva, Active, Advantage, Compact, and Compact Plus).

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

• Accu-Chek AVIVA Control (K043474)
• Accu-Chek ACTIVE Control (K012324)
• Accu-Chek ADVANTAGE Control (K032552)
• Accu-Chek COMPACT Control (K022171)
• SMS Glucose Control (K070506)

Submission Summary (Full Text)

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

A. 510(k) Number:
k081403

B. Purpose for Submission:
New Device

C. Measurand:
Quality control materials for blood glucose monitoring systems

D. Type of Test:
Not applicable

E. Applicant:
Bionostics Quality Solutions

F. Proprietary and Established Names:
Glucose Meter-Check Control Solution for Roche ACCU-CHEK

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

H. Intended Use:
1. Intended use(s):
Glucose Meter Check™ Solution is intended to assess the performance of the following Roche ACCU-CHEK blood glucose test systems:
- Roche ACCU-CHEK Advantage using Comfort Curve® test strips
- Roche ACCU-CHEK Active®
- Roche ACCU-CHEK Aviva®
- Roche ACCU-CHEK Compact® and ACCU - CHEK Compact Plus®
The Meter Check Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro diagnostic use.
2. Indication(s) for use:

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See intended use section above.

3. Special conditions for use statement(s): Over-The-Counter Use
4. Special instrument requirements:

Roche ACCU-CHEK Advantage using Comfort Curve® test strips

Roche ACCU-CHEK Active®

Roche ACCU-CHEK Aviva®

Roche ACCU-CHEK Compact® and ACCU - CHEK Compact Plus®

I. Device Description:

Glucose Meter-Check™ Control Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Meter-Check™ Control Solution is intended for use to verify the performance of the Roche ACCU-CHEK brand blood glucose monitoring systems listed in the package insert at glucose levels within the normal fasting blood glucose range for non-diabetic persons. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Accu-Chek AVIV, ACTIVE, ADVANTAGE, COMPACT Control, SMS Glucose Control

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

k043474, k012324, k032552, k022171, k070506

3. Comparison with predicate:

| Product | Glucose Meter-Chek Solution | Accu-Chek AVIVA Control | Accu-Chek ACTIVE Control | Accu-Chek ADVANTAGE Control | Accu-Chek COMPACT Control | SMS Glucose Control |
| --- | --- | --- | --- | --- | --- | --- |
| 510(k), Date | | K043474 | K012324 | K032552 | K022171 | K070506 |
| | | 04.27.05 | 12.05.01 | 09.12.03 | 07.23.02 | 04.18.07 |
| Net Fill | 4 mL | 2.5 mL | 4 mL | 4 mL | 3 mL | 3.6 mL |
| Color | red | blue | clear | blue | dark blue | red |
| Analyte | glucose | glucose | glucose | glucose | glucose | glucose |
| Container | plastic vial | plastic vial | plastic vial | plastic vial | plastic vial | plastic vial |
| Matrix | aqueous | aqueous | aqueous | aqueous | aqueous | aqueous |
| Level | normal | low high | low high | low high | low high | normal |
| Mid Assigned Range* | 107 | 40 300 | 54 173 | 61 342 | 83 410 | 169 |

*Mid Assigned Range is mean of assigned ranges for each meter (Accu-Chek ACTIVE for Glucose Meter-Check and SMS Glucose Control)

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

ISO 15197 In-vitro diagnostic test systems – requirements for self-testing in managing diabetes
ISO 14971 Medical Devices, Application of risk management to medical devices

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ISO 13485 Medical Devices-Quality Management Systems – Requirements for regulatory purposes

## 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):
A reference lot of material is used to establish the targeted glucose value on the YSI 2300. Value assignment for subsequent lots is compared to the reference lot and is acceptable if within a specified range of values. After verifying that the meters and test strips are recovering within target ranges on the Roche-branded control solutions appropriate for each meter type, multiple samples of the Glucose Meter-Check solution are analyzed on each of 2 meters on each of 3 lots of test strips. Value assignment range is determined as the mean value of all measurements ± 15% of the mean value.

Product stability has been established based on real time and accelerated studies on products with equivalent formulation matrixes and packaging. Samples are analyzed at predetermined intervals with failure defined by the sponsor as ≤ 95% recovery of the most labile analyte, glucose.

**Close Bottle:** In these evaluations, the change in glucose concentration over 24 months at 31°C is less than 5%. Ongoing real-time studies continue under refrigerated, room and elevated temperature conditions to establish final product stability and to ensure performance to within specified tolerances over labeled shelf life.

**Open Bottle:** This testing demonstrated less than 5% change in glucose over the 90 day evaluation period.

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 expected range for each glucose monitoring system is printed in the labeling. When using this control material, users are to compare their control results to the range printed in the labeling for the system being used rather than the range printed on the test strip.

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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