CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM

K111268 · Bayer Healthcare · LFR · Mar 6, 2012 · Clinical Chemistry

Device Facts

• Record ID: K111268
• Device Name: CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Bayer Healthcare
• Product Code: LFR · Clinical Chemistry
• Decision Date: Mar 6, 2012
• 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 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. The CONTOUR®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.

Device Story

System measures glucose in capillary whole blood via amperometric assay using FAD-glucose dehydrogenase. User applies 0.6 uL blood sample to test strip; capillary action draws sample into strip; reaction generates electrical current proportional to glucose concentration. Meter displays result; no manual calculation required. Device features underfilled detection and allows sample re-application within 20 seconds. Used at home by patients with diabetes for monitoring glycemic control. Meter is factory-calibrated; requires no user calibration. System includes meter, test strips, and control solutions. Output aids patients and clinicians in monitoring diabetes management effectiveness. Device supports data transmission to computer via wired connection.

Clinical Evidence

Clinical study with 115 subjects compared Contour NEXT EZ results to YSI lab analyzer using fresh fingertip capillary blood. 100% of results met accuracy criteria (within ±15 mg/dL for <75 mg/dL and ±20% for ≥75 mg/dL). 96.5% of results fell within ±10 mg/dL or ±10% of reference.

Technological Characteristics

Amperometric glucose monitoring system. Uses FAD-glucose dehydrogenase reagent. Factory-calibrated. Dimensions/form factor: Hand-held meter. Connectivity: Wired data transmission to computer. Power: Two CR2032 or DL2032 batteries. Sterilization: Not applicable (IVD). Software: Embedded firmware for signal processing and underfilled detection.

Indications for Use

Indicated for self-testing by persons with diabetes at home for quantitative measurement of glucose in fresh fingertip capillary whole blood (20-600 mg/dL). Not for diagnosis/screening of diabetes or use on neonates. Single-patient use only.

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 Blood Glucose Monitoring System (K062058)

Submission Summary (Full Text)

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K11268

# 510(k) SUMMARY

Summary of 510(k) safety and effectiveness in accordance with the requirements of 21 CFR § 807.92.

MAR - 6 20吸

| Submitter Information. | | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Name | Bayer Healthcare LLC., Diabetes Care | |
| Address | 430 South Beiger Street<br>Mishawaka IN46544<br>USA | |
| Phone number | [phone] | |
| Fax number | [phone] | |
| Establishment<br>Registration<br>Number | 1826988 | |
| Name of contact<br>person | Weiping Zhong | |
| Date prepared | February 24 2012 | |
| Name of device | | |
| Trade or<br>proprietary name | Contour® NEXT EZ Blood Glucose Monitoring System | |
| Common or usual<br>name | Blood Glucose Monitoring System | |
| Classification name | Glucose Test System | |
| Classification panel | Clinical Chemistry and Clinical Toxicology | |
| Regulation | 21 CFR § 862.1345 | |
| Product Code(s) | LFR (Glucose Dehydrogenase, Glucose), NBW<br>(System, Test, Blood Glucose, Over The Counter) | |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | Contour Blood Glucose Monitoring System (K062058) | |
| Reason for 510(k)<br>submission | Modified test strips and measurement algorithm | |
| Device description | The Contour NEXT EZ Blood Glucose Monitoring<br>System consists of:<br>1. Contour NEXT EZ Blood Glucose Meter<br>2. Contour NEXT Blood Glucose Test Strips<br>3. Contour NEXT Control Solutions | |
| Intended use of the<br>device | The Contour NEXT EZ Blood Glucose Monitoring<br>System is intended to measure the glucose<br>concentration in whole blood. | |
| Indications for use | The CONTOUR NEXT EZ blood glucose monitoring<br>system is an over the counter (OTC) device utilized for<br>self-testing by persons with diabetes at home for the<br>quantitative measurement of glucose in whole blood, is<br>for single-patient use only, and should not be shared.<br>The CONTOUR NEXT EZ blood glucose monitoring<br>system is indicated for use with fresh fingertip capillary<br>whole blood samples. The clinical utility of this device<br>is to aid in monitoring the effectiveness of your diabetes<br>control program.<br>The CONTOUR NEXT EZ blood glucose monitoring<br>system is not intended for use for the diagnosis of or<br>screening for diabetes mellitus and is not intended for<br>use on neonates.<br>The CONTOUR NEXT test strips are intended for self-<br>testing by persons with diabetes for the quantitative<br>measurement of glucose in whole blood samples from<br>20 to 600 mg/dL.<br>The CONTOUR NEXT control solutions are aqueous<br>glucose solutions intended for use in self-testing by<br>people with diabetes as a quality control check. | |
| Summary of the Technological Characteristics of<br>the New Device Compared to Predicate | | |
| SIMILARITIES to Predicate | | |
| Characteristic | Predicate<br>Contour (K062058) | Contour NEXT EZ<br>(Candidate Device) |
| Blood Sample<br>Volume | $0.6\mu L$ | Same as predicate |
| Meal Markers | Yes | Same as predicate |
| Automatic Calibration | Yes | Same as predicate |
| Communication Port | Serial Interface | Same as predicate |
| User Interface | Alphanumeric, Iconic | Same as predicate |
| Display (Technology) | LCD | Same as predicate |
| Operational Buttons | 3 | Same as predicate |
| Battery Type | Two CR2032 (3-Volt each)<br>(or DL2032) | Same as predicate |
| Displayed Countdown<br>Time | 5 seconds | Same as predicate |
| Detection Technology | Amperometric measurement<br>of blood glucose | Same as predicate |
| Reference method | Plasma equivalent | Same as predicate |
| Test Strip enzyme | FAD-Glucose Dehydrogenase | Same as predicate |
| Calibration/Coding | Autocoding (no coding for users) | Same as predicate |
| <b>DIFFERENCES from Predicate</b> | | |
| Characteristic | Predicate<br>Contour (K062058) | Contour NEXT EZ<br>(Candidate Device) |
| Mediator in test strip | Potassium Ferricyanide | MLB Mediator |
| Control Solution buffer concentration | 50mM to 100 mM | 22 mM |
| Control Solution Levels and Ranges | Low / Normal / High | Low (Level 1) / Normal (Level 2) |
| Applied voltage during glucose measurement | Constant | Pulsed |
| Hematocrit range | 0%-70% | 15%-65% |
| Measurement range | 10-600mg/dL | 20-600 mg/dL |
| Measurement Reaction time | 5 seconds | 7 seconds |
| Sample type | • Fresh fingertip capillary whole blood samples<br>• Venous whole blood samples<br>• Arterial whole blood samples<br>• Neonatal blood samples | • Fresh fingertip capillary whole blood samples |
| Intended users | For home and professional uses | For home use, single user only |
| "Double Dip" function | No<br>Inadequate sample volume results in error message | Yes<br>System prompts for an additional application of blood in a certain time frame when a underfilled blood sample is detected |

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| PERFORMANCE DATA | | | | | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|----------------------------------------------|---------------------------------------------|---------------------------------------------|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR<br>DETERMINATION OF SUBSTANTIAL EQUIVALENCE | | | | | |
| Performance Test Summary-New Device | | | | | |
| Characteristic | Results Summary | | | | |
| Accuracy | System Accuracy Evaluation (ISO 15197 Section 7.3/7.4.1)<br>Reference: 510(k) submission, Section – 001_015 System<br>Accuracy (Book Additional Information 2)<br>Protocol: Six Contour NEXT EZ meters, three lots of test strips and<br>100 blood samples were tested in replicates. The first replicate (a<br>total of three hundred data points) was analyzed. Samples were also<br>tested in parallel on a YSI 2300 STAT PLUS glucose analyzer as<br>reference values<br>Acceptance Criteria: A minimum of 95 % of the individual glucose<br>results shall fall within ± 15 mg/dL of the results obtained on the YSI<br>analyzer at glucose concentrations < 75 mg/dL, and within ± 20 % at<br>glucose concentrations ≥75 mg/dL.<br>Results: All data (100%) fell within ±20% or ±15 mg/dL of the<br>laboratory comparison method. Further, the data show an improved<br>accuracy in that 100% of test results fall within ±10 mg/dL<br>(<75mg/dL) and 99.2% fall within ±10% (≥ 75 mg/dL) of the<br>laboratory comparison method. | | | | |
| | Results<br>within: | ±5 mg/dL | ±10 mg/dL | ±15 mg/dL | |
| | YSI Glucose<br><75 mg/dL | 49 of 51<br>(96.1%) | 51 of 51<br>(100%) | 51 of 51<br>(100%) | |
| | Results<br>within: | ±5% | ±10% | ±15% | ±20% |
| | YSI Glucose ≥<br>75 mg/dL | 203 of 249<br>(81.5%) | 247 of 249<br>(99.2%) | 249 of 249<br>(100%) | 249 of 249<br>(100%) |
| | Results<br>within:<br>Total | ±5 mg/dL<br>or 5%<br>252 of 300<br>(84%) | ±10 mg/dL<br>or 10%<br>298 of 300<br>(99.3%) | ±15 mg/dL<br>or 15%<br>300 of 300<br>(100%) | ±15 mg/dL<br>or 20%<br>300 of 300<br>(100%) |
| Precision | Repeatability (ISO 15197 Section 7.2.2)<br>Reference: 510(k) submission, Section Labeled Performance<br>Testing - Bench<br>Protocol: Venous blood was tested at five glucose concentration<br>ranges: 30-50, 51-110, 111-150, 151-250 and 251-400mg/dL. Two<br>operators tested one lot of test strips on 10 meters with 10 replicates per | | | | |

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| | meter (n=100). | | | | |…