Contour Next Control Solution

K151742 · Bayer Healthcare · JJX · Sep 23, 2015 · Clinical Chemistry

Device Facts

• Record ID: K151742
• Device Name: Contour Next Control Solution
• Applicant: Bayer Healthcare
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Contour Next Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check to ensure that the Contour Next Blood Glucose Monitoring Systems are working properly.

Device Story

Contour Next Control Solution is an aqueous quality control material used to verify the accuracy of Contour Next Blood Glucose Monitoring Systems. The device consists of two levels (Level 1 and Level 2) containing controlled amounts of glucose, preservatives, and a surfactant. The surfactant was added to the reformulated version to reduce solution adherence to the bottle neck, preventing out-of-range results and misidentification of control results by the meter. Users apply the solution to the blood glucose monitoring system; the system reads the glucose concentration. If the result falls within the acceptable range printed on the test strip vial label, the system is functioning correctly. The device is intended for home use by patients with diabetes.

Clinical Evidence

No clinical data. Bench testing only. Stability testing confirmed 18-month shelf life and 6-month open-vial stability at 9–30°C. Value assignment is based on replicate readings across 36 instruments with ranges set at ±11% of the calculated mean.

Technological Characteristics

Aqueous glucose solution containing preservatives and a surfactant. Traceable to NIST SRM #917. Two levels (Level 1 and Level 2). Storage temperature 9–30°C. Shelf life 18 months (closed), 6 months (open).

Indications for Use

Indicated for use by people with diabetes as a quality control check for Contour Next Blood Glucose Monitoring Systems.

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

• Contour Next Control Solution (K111268)

Submission Summary (Full Text)

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

A. 510(k) Number:
k151742

B. Purpose for Submission:
Device modification resulting from a recall

C. Measurand:
Glucose

D. Type of Test:
Quality control solution

E. Applicant:
Bayer Healthcare LLC, Diabetes Care

F. Proprietary and Established Names:
Contour Next Control Solution

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

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H. Intended Use:

1. Intended use(s):

See Indication(s) for use below.

2. Indication(s) for use:

Contour Next Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check to ensure that the Contour Next Blood Glucose Monitoring Systems are working properly.

3. Special conditions for use statement(s):

For in vitro diagnostic use only

4. Special instrument requirements:

To be used with Contour Next Blood Glucose Monitoring Systems

I. Device Description:

The Contour Next Control Solution is an aqueous quality control material, used as a quality control check to ensure that the Bayer Contour Next Blood Glucose Monitoring Systems are reading accurately. Two levels are available (Level 1 and Level 2). Each level contains a controlled amount of glucose, preservatives and other non-reactive ingredients. The range of acceptable values is printed on the test strip vial labels.

The candidate device has been reformulated by the addition of a surfactant to reduce adherence of the solution to the inside of the neck of the bottle which can result in out-of-range results and results not marked as control results by the meter.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Contour Next Control Solution

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

K111268

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3. Comparison with predicate:

| Similarities/Differences | | |
| --- | --- | --- |
| Item | Candidate Device Contour Next Control Solution | Predicate Device Contour Next Control Solution (k111268) |
| Indications for use | Contour Next Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check to ensure that the Contour Next Blood Glucose Monitoring Systems are working properly. | Same |
| Levels | Level 1 and Level 2 | Same |
| Surfactant | Yes | No |
| Glucose concentration | 0.025% Level 1
0.067% Level 2 | 0.03% Level 1
0.07% Level 2 |
| Storage temperature | 9 – 30° C (18 month closed vial, 6 month open vial) | Same |

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

Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material

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

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

The Contour Next Control Solution is traceable to NIST SRM #917

**Control Solution Value Assignment:**

Value assignment for the control solutions is the same as the predicate, and is based on replicate reading on each of thirty-six instruments and the range is assigned as $\pm 11\%$ relative to the calculated mean.

**Control Solution Stability:**

Stability testing protocols and acceptance criteria for the reformulated glucose control solutions were reviewed and found to be acceptable. The manufacturer claims a shelf life stability of 18 months and an open-vial stability of 6 months at the recommended storage temperatures of $9^{\circ}\mathrm{C}$ to $30^{\circ}\mathrm{C}$, which is unchanged from the predicate device.

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

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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:
The acceptable range for each control solution level is printed on the test strip vial label. Users ensure that the results they obtain when using the control material are within those ranges.

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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