CONTOUR NEXT EZ BLOOD GLUCOSE METER

K130265 · Bayer Healthcare, LLC · NBW · Jun 23, 2014 · Clinical Chemistry

Device Facts

• Record ID: K130265
• Device Name: CONTOUR NEXT EZ BLOOD GLUCOSE METER
• Applicant: Bayer Healthcare, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CONTOUR®NEXT EZ blood glucose monitoring system is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single patient use only, and should not be shared. The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program. The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use for screening for diabetes mellitus and is not intended for use on neonates. The CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

Device Story

Handheld blood glucose meter; uses dry reagent test strips; measures capillary whole blood glucose via amperometric principle (FAD-GDH enzyme reaction). User applies blood to strip; meter calculates glucose concentration based on electrical current; displays result. Used at home by patients with diabetes. Modifications include: improved glucose calculation algorithm for low-temperature performance (<15°C); enhanced blood detection algorithm for 'second chance' sampling (re-application of blood if under-filled); and error detection for moisture-damaged test strips. Meter stores 480 results; connects to PC via serial-to-USB cable. Benefits include reduced error codes and improved accuracy during under-fill or low-temperature conditions.

Clinical Evidence

No clinical data. Bench testing only. Performance characteristics, precision, linearity, and method comparison were previously cleared under K111268. Studies were performed to validate the three specific algorithm modifications.

Technological Characteristics

Amperometric sensing; FAD-GDH enzyme reagent. ABS/AS plastic housing. Powered by two 3V lithium batteries (DL2032/CR2032). Segmented LCD display. Connectivity: Serial-to-USB. Operating range: 41-113°F, 10-93% RH. Autocoding. Software-based algorithms for temperature compensation, under-fill detection, and moisture-damage detection.

Indications for Use

Indicated for self-testing by persons with diabetes to quantitatively measure glucose in fresh fingertip capillary whole blood. Not for neonates, not for diabetes screening. Range: 20-600 mg/dL.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Contour Next EZ Blood Glucose Monitoring System (K111268)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCEDETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k130265

B. Purpose for Submission:
Modification of the Contour Next EZ Blood Glucose Meter with three changes made to the glucose measuring algorithm to enhance low temperature measurements, allow blood re-application, and enhance moisture detection.

C. Measurand:
Glucose in capillary whole blood from fingertip.

D. Type of Test:
Quantitative amperometric assay (FAD-glucose dehydrogenase)

E. Applicant:
Bayer Health Care LLC, Diabetes Care

F. Proprietary and Established Names:
CONTOUR® NEXT EZ Blood Glucose Monitoring System

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1345 Glucose Test System
2. Classification:
Class II
3. Product code:
LFR - Glucose dehydrogenase, glucose
NBW - Blood glucose test system, Over-the-Counter
4. Panel:
Clinical Chemistry - 75

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H. Intended Use:

1. Intended use(s):
Refer to indications for use below.

2. Indication(s) for use:
The CONTOUR® NEXT EZ blood glucose monitoring system is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared.

The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program.

The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

3. Special conditions for use statement(s):
For in vitro diagnostic use only.
For over the counter use.
Not for neonatal use.
Not for use in Critically Ill
Not for screening or diagnosis of diabetes mellitus.

Single-patient use systems are for use on single patients only and should not be shared.

The following Contraindications statement is included in the labeling:
Capillary blood glucose testing may not be clinically appropriate for persons with reduced peripheral blood flow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood.

4. Special instrument requirements:
CONTOUR® NEXT EZ Blood Glucose Meter

I. Device Description:
The CONTOUR® NEXT EZ Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. The modified device is capable of detecting low sample when sensor is either severely under-filled (less than half-full) or moderately under-filled (more than half-full), and allowing the user to re-apply more blood onto the same strip within 20 seconds.

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Liquid CONTOUR®NEXT Control Solution (level 1 and 2) and the CONTOUR®NEXT Test Strips were cleared under k111268. Contour®NEXT level 2 control solution is included in the kit.

## J. Substantial Equivalence Information:

1. Predicate device name:
CONTOUR®NEXT EZ Blood Glucose Monitoring System

2. Predicate 510(k) number:
K111268

3. Comparison with predicate:
| Item | CONTOUR® NEXT EZ Blood Glucose Monitoring System; Predicate Device (k111268) | CONTOUR® NEXT EZ Blood Glucose Monitoring System; Modified Device (k130265) |
| --- | --- | --- |
| Similarities with Predicate | | |
| Intended Use | Intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. | Same |
| Detection method | Quantitative amperometric assay (FAD-glucose dehydrogenase) | Same |
| Sample type | Capillary whole blood | Same |
| Sample sites | Fingertip | Same |
| Test Strip | CONTOUR®NEXT Test Strips | Same |
| Control Solution | CONTOUR®NEXT Control Solutions (Level 1 and 2) | Same |
| Test Strip Underfilled Detection | Yes | Same |
| Calibration | Autocoding (no coding for users) | Same |
| Measurement Range | 20-600 mg/dL | Same |
| Hematocrit Range | 15-65% | Same |
| Blood Sample Volume | 0.6 uL | Same |
| Reaction Time | 5 seconds | Same |
| Operating Conditions | 41-113°F / 10-93% RH | Same |
| Battery Type | Two 3-volt lithium batteries (CR2032 or DL2032) | Same |

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| Illuminated Strip Port | No | Same |
| --- | --- | --- |
| Operational Buttons | Two button - choice selection and menu/power button | Same |
| Sound | A beep sounds when the meter is turned on, a test strip is inserted, when a test strip is filled with blood, or when a test result appears on the display. Two beeps sound when the meter turns off or to indicate an error. Twenty beeps sound for a programmed reminder. | Same |
| Meter life | Five years | Same |
| Validated Product Used for Cleaning & Disinfection | Clorox Germicidal wipes | Same |
| Test Reminder | Yes | Same |
| Display (technology) | Segmented (LCD), Alphanumeric characters and icons | Same |
| Display visibility | Daylight only | Same |
| Error Message Displays | No, but error codes and symbols are displayed and their meanings are provided in the system’s User Guide | Same |
| Communication Link to Computer | Via serial to USB cable | Same |
| Test Results in Memory | 480 Results | Same |
| Meter Materials | Case Top/Bottom: ABS Buttons: AS | Same |
| Before and After Meal Marker | Yes, when used in advanced setting | Same |

## Differences from Predicate

| Characteristic | CONTOUR® NEXT EZ Blood Glucose Monitoring System; Predicate (k111268) | CONTOUR® NEXT EZ Blood Glucose Monitoring System; Modified Device (k130265) |
| --- | --- | --- |
| Glucose Calculation Algorithm that ensures consistent performance at low temperatures (<15°C) | No | Yes |

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| Improved blood detection algorithm to allow blood reapplication when sensor is either severely under-filled (less than half-full) or moderately under-filled (more than half-full) | No | Yes |
| --- | --- | --- |
| Error detection algorithm to detect test strips that have been damaged by exposure to excessive moisture | No | Yes |

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

ISO 15197: 1n vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.

ISO 14971: Medical Devices - Application of risk management to devices.

IEC 61326-1, IEC 61326-2-6: Electrical equipment for measurement, control and laboratory use - EMC requirements.

IEC 61010-1, IEC 61010-2-101: Safety requirements for electrical equipment for measurement, control and laboratory use.

L. Test Principle:

CONTOUR NEXT EZ blood glucose test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the strip. The blood sample is drawn into the tip of the test strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) and the mediator. Electrons are generated, producing a current that is proportional to the glucose in the sample. After the reaction time, the glucose concentration in the sample is displayed. No calculation is required.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Previously cleared under k111268.

b. Linearity/assay reportable range:

Previously cleared under k111268.

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

Previously cleared under k111268.

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d. Detection limit:
Previously cleared under k111268.

e. Analytical specificity:
Previously cleared under k111268.

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Previously cleared under k111268.
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:
The product labeling contains the following statement: "Non diabetic plasma glucose concentrations should be &lt;100 mg/dL in the fasting state and &lt;140 mg/dL in the post-prandial state.* You should consult with your healthcare professional for glucose values specific to your needs."

*Reference: American Diabetes Association: Standards of Medical Care in Diabetes – 2013. Diabetes Care 2013; volume 36, supplement 1: S13.

N. Instrument Name:
CONTOUR NEXT EZ glucose meter

O. System Descriptions:
1. Modes of Operation:
Amperometric.
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?

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Yes ☐ X or No ☐

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?:

Yes ☐ or No ☐ X

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ☐ X or No ☐

3. Specimen Identification:

There is no sample identification function with this device. Samples are applied directly to the test strip as they are collected.

4. Specimen Sampling and Handling:

This device is intended for use with fingertip capillary whole blood which is applied directly to the test strip.

5. Calibration:

The device is factory calibrated and requires no additional calibration by the user.

6. Quality Control:

The sponsor recommends the use of Level 1 and Level 2 CONTOUR NEXT control solutions with this system. Control solution level 2 is included in the kit. These controls can be purchased using the contact information provided in the user manual. When the test strip is inserted into the glucose meter, control material can be measured by following the instructions for “Control Solution Testing” provided in the user guide for the meter. The CONTOUR NEXT EZ meter will automatically recognize and mark the control result. Control results will not be included in blood glucose averages.

P. The “Performance Characteristics” Section above:

The studies performed to mitigate the risks associated with the three modifications to the glucose measuring algorithm, support the algorithm changes.

Other:

1) Altitude Study:

Previously cleared under k111268.

2) Sample Volume

Previously cleared under k111268.

3) Usability Study

Previously cleared under k111268.

4) Readability Assessment

Previously cleared under k111268.

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5) Customer Service Telephone Number

Customer service is available 24 hours a day, 7 days a week. The toll free phone number is 1-800-348-8100 for customer support.

6) EMC Testing

Previously cleared under k111268.

7) Cleaning and Disinfection

Previously cleared under k111268.

Q. Proposed Labeling:

There were no labeling changes made to all the labeling cleared under k111268.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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