CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
Device Facts
| Record ID | K110587 |
|---|---|
| Device Name | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) |
| Applicant | Bayer Healthcare, LLC |
| Product Code | LFR · Clinical Chemistry |
| Decision Date | Mar 28, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The CONTOUR® LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip only. CONTOUR® 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® LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps through use of radio frequency communication. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
Device Story
System consists of CONTOUR LINK meter, test strips, lancing device, and control solution; measures blood glucose via amperometric technology using FAD-glucose dehydrogenase enzyme. User applies capillary blood sample to test strip; meter provides quantitative glucose result in 5 seconds. Device features RF wireless transmission to compatible Medtronic MiniMed Paradigm insulin pumps. Used in home settings by patients for self-monitoring; output assists in insulin dosing decisions. Benefits include automated data transfer to insulin pump, reducing manual entry errors and facilitating diabetes management.
Clinical Evidence
Method comparison study performed with 100 diabetic subjects using 400 samples (fresh and manipulated capillary blood). Comparison against YSI 2300 STAT PLUS analyzer. Results showed 98.5% of readings met ISO 15197 accuracy criteria (within ±15 mg/dL for <75 mg/dL and ±20% for ≥75 mg/dL). Precision evaluated via within-run and between-day studies; %CV ranged from 1.5% to 4.2%.
Technological Characteristics
Amperometric glucose measurement using FAD-glucose dehydrogenase enzyme. Measurement range 20-600 mg/dL. Connectivity via RF wireless transmission to Medtronic insulin pumps. No coding required. Hematocrit range 20-65%. Sample type: capillary whole blood (fingertip only).
Indications for Use
Indicated for persons with diabetes (excluding neonates) for quantitative measurement of glucose in fresh capillary whole blood from the fingertip. Not for use on critically ill patients (e.g., severe hypotension, shock, DKA).
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
Submission Summary (Full Text)
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#### 510(k) SUMMARY
Summary of 510(k) safety and effectiveness in accordance with the requirements of 21 . CFR 807.92.
| Submitter Information | | |
|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Name | Bayer Healthcare | |
| Address | 555 White Plains Road<br>Tarrytown, NY 10591 | |
| Phone number | (914) 366-1800 | |
| Fax number | (914) 366-1899 | |
| Establishment<br>Registration<br>Number | 3003962513 | |
| Name of contact<br>person | Chuck Ryan | |
| Date prepared | March 27, 2012 | |
| Name of device | | |
| Trade or proprietary<br>name | CONTOUR® LINK | |
| Common or usual<br>name | Wireless 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 (System, Test, Blood Glucose, Over The Counter) | |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | CONTOUR Blood Glucose Meter (K062058)<br>OneTouch UltraLink Blood Glucose Meter (K073231) | |
| Reason for 510(k)<br>submission | Addition of RF wireless transmission capability | |
| Device description | The CONTOUR LINK Wireless Blood Glucose<br>Monitoring System features the CONTOUR LINK<br>Wireless Blood Glucose Monitor and the currently<br>marketed CONTOUR Blood Glucose Test Strips, among<br>other components (e.g., lancing device, lancets and<br>control solution) | |
| Intended use of the device | See Indications for Use below | |
| Indications for use | The CONTOUR® LINK Wireless Blood Glucose<br>Monitoring System is an over the counter (OTC) device<br>utilized by persons with diabetes in home settings for the<br>measurement of glucose in whole blood, and is for<br>single-patient use only and should not be shared. The<br>CONTOUR® LINK Wireless Blood Glucose Monitoring<br>System is indicated for use with fresh capillary whole<br>blood samples drawn from the fingertip only.<br>CONTOUR® test strips are intended for self-testing by<br>persons with diabetes for the quantitative measurement | |
| | of glucose in whole blood samples from 20 to 600<br>mg/dL. | |
| | The CONTOUR® LINK Wireless Blood Glucose<br>Monitoring System is intended to be used to transmit<br>glucose values to Medtronic MiniMed Paradigm Insulin<br>Pumps or Medtronic MiniMed Paradigm REAL-Time<br>Revel Insulin Pumps through use of radio frequency<br>communication. | |
| | The CONTOUR® LINK Wireless Blood Glucose<br>Monitoring System is not intended for the diagnosis of or<br>screening for diabetes mellitus and is not intended for<br>use on neonates. | |
| Summary of the Technological Characteristics of the New Device Compared to<br>Predicate 1 | | |
| SIMILARITIES to Predicate 1 | | |
| Characteristic | New Device<br>Bayer's CONTOUR LINK<br>meter | Predicate 1<br>Bayer's CONTOUR meter<br>K062058 |
| Detection<br>Technology | Amperometric measurement of<br>blood glucose | same |
| Reference method | Plasma equivalent | same |
| Test strip | CONTOUR test strip | same |
| Test Strip enzyme | Glucose Dehydrogenase FAD | same |
| Calibration/Coding | No coding needed | same |
| Accuracy | Meets ISO 15197 requirements | same |
| Reaction time | 5 seconds | same |
| <b>DIFFERENCES from Predicate 1</b> | | |
| RF<br>Communication<br>Protocol | Transmits glucose values to<br>compatible MiniMed Paradigm<br>and Guardian REAL Time<br>devices. | No RF capability |
| Alternative site<br>testing | Fingertip only | Fingertip, palm or forearm |
| Measurement<br>range | 20-600 mg/dL | 10-600 mg/dL |
| Sample type | Capillary whole blood samples<br>only. Not for use on neonates. | Capillary, venous, and<br>arterial whole blood<br>samples and neonatal blood<br>samples |
| Hct range | 20-65% | 0-70% |
| <b>Summary of the Technological Characteristics of the New Device Compared to Predicate 2</b> | | |
| <b>SIMILARITIES to Predicate 2</b> | | |
| Characteristic | New Device<br>Bayer's CONTOUR LINK<br>meter | Predicate 2<br>LifeScan OneTouch<br>UltraLink meter<br>K073231 |
| Detection<br>Technology | Amperometric measurement of<br>blood glucose | same |
| Reference method | Plasma equivalent | same |
| Accuracy | Meets ISO 15197 requirements | same |
| Sample type | Capillary whole blood samples only. Not for use on neonates. | same |
| Reaction time | 5 seconds | same |
| Measurement range | 20-600 mg/dL | same |
| RF Communication Protocol | Transmits glucose values to compatible Medtronic MiniMed devices. | same |
| DIFFERENCES from Predicate 2 | | |
| Test Strip | CONTOUR test strip | OneTouch Ultra test strip |
| Test Strip enzyme | Glucose Dehydrogenase FAD | Glucose Oxidase |
| Alternative site testing | Fingertip only | Fingertip, palm or forearm |
| Calibration/Coding | No coding needed | Manual coding required |
| Hct range | 20-65% | 30-55% |
| PERFORMANCE DATA<br>SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR<br>DETERMINATION OF SUBSTANTIAL EQUIVALENCE | | |
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Performance Test Summary-New Device
Characteristic
Results Summary
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| Precision | Repeatability (ISO 15197 Section 7.2.2) | | | |
|-----------|---------------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------|-------|
| | Reference: 510(k) submission, Section 018-4 | | | |
| | | | | |
| | | | Protocol: Venous blood was tested at five glucose | |
| | | | concentration ranges: 30 - 50, 51 - 110, 111 - 150, 151 - 250 and | |
| | | | 251 - 400mg/dL. One lot of test strips was tested on 10 meters with | |
| | | 10 replicates per meter (n=100). | | |
| | | | | |
| | | | Acceptance criteria: No ISO acceptance criteria stated. Internal | |
| | | | acceptance criteria: Repeatability test must perform within the | |
| | | established accuracy requirements. | | |
| | | | (Cpk values > 1.0 when compared to established accuracy | |
| | | requirements of ± 20% or ± 15mg/dL.). | | |
| | | | | |
| | | | Results: Cpk values are greater than 1.0 when compared to | |
| | | | established accuracy requirements of ± 20% or ± 15mg/dL. | |
| | | Mean, SD and %CV were as follows: | | |
| | Mean, mg/dL | | SD,mg/dL | CV% |
| | 41.8 | | 1.26 | |
| | 78.1 | | 1.99 | 3.02% |
| | 125.7 | | | 2.55% |
| | 198.0 | | 2.67 | 2.12% |
| | 312.3 | | 4.32 | 2.18% |
| | | | 5.01 | 1.60% |
| | | | | |
| | | | Intermediate Precision (ISO 15197 Section 7.2.3) | |
| | | Reference: 510(k) submission, Section 018-4 | | |
| | | | | |
| | | | Protocol: Three levels of control solutions (Low, Normal and High) | |
| | | | were tested on 10 meters over the course of 10 days. One | |
| | | | measurement was taken per meter per lot per control solution per | |
| | day. | | | |
| | Acceptance criteria: Cp value for 10 days> 1.0 when compared to | | | |
| | established limits of + 11% or +5mg/dL. | | | |
| | Results: Cp values are over 1.0 when compared to established limits | | | |
| | of + 11% or + 5mg/dL. | | | |
| | | | | |
| | Mean, SD and %CV were as follows: | | | |
| | Control | Mean, | SD,mg/dL | CV% |
| | Level | mg/dL | | |
| | Low | 38.9 | 0.55 | 1.41 |
| | Normal | 121.7 | 1.26 | 1.04 |
| | High | 354.9 | 4.49 | 1.26 |
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| Accuracy | System Accuracy Evaluation (ISO 15197 Section 7.3)<br>Reference: 510(k) submission, Section 018-5 | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------|-------|
| | Protocol: Fresh capillary blood was collected in the glucose<br>range distribution specified by ISO 15197 Section 7.3. One<br>hundred blood samples were tested using each of two CONTOUR<br>test strip lots on two CONTOUR LINK meters for a total of 400<br>readings. Samples were also tested in parallel on a YSI 2300<br>STAT PLUS glucose analyzer. | | | |
| | Acceptance Criteria: A minimum of 95 % of the individual<br>glucose results shall fall within ± 15 mg/dL of the results<br>obtained on the YSI analyzer at glucose concentrations < 75<br>mg/dL, and within ± 20 % at glucose concentrations ≥75 mg/dL. | | | |
| | Results: 98.7 % of the individual glucose results fell within ± 15<br>mg/dL of the results obtained on the YSI analyzer at glucose<br>concentrations < 75 mg/dL. 98.5% fell within ± 20 % at glucose<br>concentrations ≥75 mg/dL. | | | |
| Linearity/assay<br>reportable range | Established in predicate submission (k062058). | | | |
| | Reference: 510(k) submission, Section 018-7<br>Two studies were conducted to establish the linearity of the<br>CONTOUR system throughout the entire reportable range of 10 to<br>600 mg/dL. In one study, blood with a hematocrit level of 40% was<br>adjusted to plasma glucose concentrations of 20, 30, 40, 50, and 60<br>mg/dL and tested with three CONTOUR lots, 24 sensors per lot. All<br>results fell within ±10mg/dL of the YSI reference value, satisfying<br>the acceptance criteria. | | | |
| | Reference Level,<br>mg/dL | Mean,<br>mg/dL | Bias,<br>mg/dL | CV, % |
| | 29.5 | 25.5 | -4.0 | 3.2 |
| | 40.6 | 35.3 | -5.3 | 4.2 |
| | 50.6 | 45.5 | -5.0 | 2.1 |
| Eight meters were used, with three sensors per lot tested on each.<br>All results fell within ±20% at glucose level of 75 mg/dL and<br>above, and within ±15 mg/dL at glucose level below 75 mg/dL.<br>This met the acceptance criteria. | | | | |
| Reference Level,<br>mg/dL | Mean,<br>mg/dL | Bias | CV, % | |
| 26.4 | 25.8 | -0.5 mg/dL | 3.5 | |
| 51.1 | 47.2 | -3.9 mg/dL | 2.2 | |
| 77.6 | 74.8 | -3.5% | 2.1 | |
| 118.1 | 115.2 | -2.5% | 2.7 | |
| 195.8 | 194.7 | -0.5% | 2.3 | |
| 300.0 | 304.9 | 1.6% | 2.3 | |
| 394.5 | 398.3 | 1.0% | 1.5 | |
| 551.0 | 530.5 | -3.7% | 1.7 | |
| Traceability | The Yellow Springs Instruments Stat Plus 2300 analyzer (YSI) is<br>traceable to the hexokinase method developed collaboratively by<br>the FDA, CDC, NIST and AACC. The hexokinase method is<br>incorporated in a Bayer procedure that utilizes NIST Standard<br>Reference Material 917, dry D-glucose. Glucose serum controls<br>from an outside supplier were characterized by Bayer using the<br>hexokinase method as a reference. For each day that Bayer's YSI<br>instruments were used as the reference method, the serum<br>controls were analyzed to ensure that the instruments were in<br>control. | | | |
| Detection limit | Established in predicate submission (k062058) as 10-600 mg/dL;<br>stated in CONTOUR LINK specifications as 20-600 mg/dL due<br>to absence of neonatal claim. | | | |
| Reference: 510(k) submission, Section 018-7<br>The low glucose concentrati…
