CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) by BAYER HEALTHCARE, LLC

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 Description

The CONTOUR LINK Wireless Blood Glucose Monitoring System features the CONTOUR LINK Wireless Blood Glucose Monitor and the currently marketed CONTOUR Blood Glucose Test Strips, among other components (e.g., lancing device, lancets and control solution)

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance
Precision
Repeatability	Cpk values > 1.0 when compared to established accuracy requirements of ± 20% or ± 15mg/dL. (Internal acceptance criteria; no ISO criteria stated).	Cpk values are greater than 1.0 when compared to established accuracy requirements of ± 20% or ± 15mg/dL. (Mean, SD, and %CV provided for 5 glucose levels, e.g., 41.8 mg/dL with 3.02% CV, 125.7 mg/dL with 2.12% CV, 312.3 mg/dL with 1.60% CV).
Intermediate Precision	Cp value for 10 days > 1.0 when compared to established limits of + 11% or +5mg/dL.	Cp values are over 1.0 when compared to established limits of + 11% or + 5mg/dL. (Mean, SD, and %CV provided for Low, Normal, and High control levels, e.g., Low: 38.9 mg/dL with 1.41% CV, Normal: 121.7 mg/dL with 1.04% CV, High: 354.9 mg/dL with 1.26% CV).
Accuracy	A minimum of 95% of individual glucose results shall fall within ± 15 mg/dL of the results obtained on the YSI analyzer at glucose concentrations < 75 mg/dL, and within ± 20% at glucose concentrations ≥ 75 mg/dL (ISO 15197 Section 7.3). This is for self-test results and HCP-test results.	System Accuracy Evaluation (ISO 15197 Section 7.3): 98.7% of individual glucose results fell within ± 15 mg/dL of the YSI analyzer at glucose concentrations < 75 mg/dL. 98.5% fell within ± 20% at glucose concentrations ≥ 75 mg/dL.Clinical Study: 95.5% of self-test results and 99.4% of HCP-test results satisfy ISO 15197 accuracy specifications.
Linearity/Assay Reportable Range	In one study (K062058 data, for lower range), all results fell within ±10mg/dL of the YSI reference value. Additionally, all results fell within ±20% at glucose level of 75 mg/dL and above, and within ±15 mg/dL at glucose level below 75 mg/dL (for a separate linearity study for K062058 described).	Established in predicate submission (K062058). Two linearity studies are mentioned to cover 10-600 mg/dL. The results satisfy the acceptance criteria for both: for lower ranges (20-60 mg/dL), bias and CV provided; for extended linearity (26.4-551.0 mg/dL), bias and CV provided.
Detection Limit	Detection limit established as 10-600 mg/dL in predicate (K062058).	Stated in CONTOUR LINK specifications as 20-600 mg/dL (due to absence of neonatal claim). Confirmed by testing: 5 mg/dL samples displayed "Lo"; 900 mg/dL or greater displayed "Hi."
Analytical Specificity (Interferences)	Signal Change Criterion at 80 and 300 mg/dL glucose: ≤10% for Bilirubin, Acetaminophen, Uric Acid, Ascorbic Acid. ≤7% for Maltose, Galactose. (No specific criterion for Xylose, which interfered).	Bilirubin (>20 mg/dL): Passed (≤10%). Acetaminophen (>22 mg/dL): Passed (≤10%). Uric Acid (>18 mg/dL): Passed (≤10%). Ascorbic Acid (>30 mg/dL): Passed (≤10%). Maltose (>200 mg/dL): Passed (≤7%). Galactose (>200 mg/dL): Passed (≤7%). Xylose: Interferes with test.
Comparative Performance (New vs. Predicate device)	A proportionally weighted Deming regression of the CONTOUR sensor data: slope and 95% confidence interval around it shall include a 1.0; intercept and 95% confidence interval around it shall include 0.0. Bias of CONTOUR LINK system is not significantly larger (α=0.05) than predicate; 95% CI width for % difference within ±4% (±3 mg/dL if glucose <75mg/dL) and includes ±1% (or ±0.75mg/dL). Imprecision of CONTOUR® LINK not significantly larger (α=0.05) than predicate OR Cpk values > 1.33.	Linearity/assay reportable range: Slope: 0.989 (95% CI 0.989 to 1.008); Intercept: 0.49 (95% CI -0.4 to 1.38 mg/dL). Meets acceptance criteria.Comparison Study (new vs predicate meters): Bias of the CONTOUR LINK system is not significantly larger than the predicate CONTOUR system. System performance meets acceptance criteria.
Usability/Self-testing Performance	Probability exceeds 95% that a randomly selected person will successfully perform any of the tasks required for successful execution of the blood glucose testing procedure.	Statistical analysis indicates probability exceeds 95% that a randomly selected person will successfully perform any of the tasks required. 99% of subjects either needed no assistance or assistance comparable to a Customer Service call.

2. Sample Sizes Used for the Test Set(s) and Data Provenance

Repeatability Test: 10 meters, 10 replicates per meter. Total n=100.
- Data Provenance: Not explicitly stated, but likely in-house lab testing (prospective).
Intermediate Precision Test: 10 meters tested over 10 days, one measurement per meter per lot per control solution per day.
- Data Provenance: Not explicitly stated, but likely in-house lab testing (prospective).
System Accuracy Evaluation (ISO 15197): 100 fresh capillary blood samples tested using 2 test strip lots on 2 CONTOUR LINK meters. Total of 400 readings.
- Data Provenance: Fresh capillary blood samples (prospective). Country of origin not specified, but typically conducted in the submitting company's R&D facilities or contracted labs.
Linearity/Assay Reportable Range (Predicate K062058 data cited):
- Study 1: Blood with 40% hematocrit, 5 glucose concentrations, 3 CONTOUR lots, 24 sensors per lot.
- Study 2: 8 meters, 3 sensors per lot tested on each.
- Data Provenance: Unspecified, but derived from the predicate device's 510(k) submission (K062058), so likely both in-house lab testing (prospective) and potentially some clinical data.
Detection Limit: 3 production lots of CONTOUR sensors, 24 sensors per sample for manipulated blood samples.
- Data Provenance: Not explicitly stated, likely in-house lab testing (prospective).
Analytical Specificity (Interferences): Not explicitly stated how many samples or replicates were performed for each compound.
- Data Provenance: Not explicitly stated, likely in-house lab testing (prospective).
Method Comparison with Predicate Device (Linearity/Assay Reportable Range comparison): 444 paired readings collected.
- Data Provenance: Fresh venous blood; likely prospective in-house lab testing.
Method Comparison with Predicate Device (CONTOUR LINK vs. CONTOUR meters): 111 subjects (fingerstick study). Two lots of CONTOUR sensors, four CONTOUR meters. RF function of CONTOUR LINK left on.
- Data Provenance: Fresh capillary blood samples from 111 subjects. Likely prospective clinical or usability study. Country unspecified.
Clinical Study (Usability and Accuracy - New Device): 77 adults.
- Data Provenance: Adults aged 20-85 (fresh capillary blood, self-test and HCP-test results). Likely prospective clinical or usability study. Country unspecified.
Clinical Study (Usability and Accuracy - Predicate K062058 cited): 109 adults.
- Data Provenance: Adults aged 20-75 (self-testing). Derived from predicate device's 510(k) submission (K062058). Likely prospective clinical or usability study. Country unspecified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

No human experts were used for establishing ground truth. The ground truth in these studies was established using a high-precision laboratory reference method.

4. Adjudication Method for the Test Set

Not applicable. Since the ground truth was established by a laboratory reference instrument (YSI 2300 STAT PLUS glucose analyzer) rather than human experts, there was no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done in the context of comparing human readers (interpreting images/cases) with and without AI assistance. This device is a blood glucose meter, and its performance is assessed against a laboratory reference standard, not against human interpretation of images.
A comparative performance study was done between the new device (CONTOUR LINK) and the predicate device (CONTOUR) using blood samples, showing equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the device's accuracy tests (Precision, System Accuracy, Linearity, Detection Limit, Analytical Specificity) represent standalone performance, as these evaluate the device's ability to measure glucose values compared to a reference method, without human intervention in the measurement process itself beyond standard operation. The clinical study also included "HCP-test results" which implies professional use, which would also be standalone.
The clinical usability studies involved human users (self-testers and HCPs) operating the device, but the accuracy assessment within these studies is still primarily evaluating the device's standalone measurement capability under real-world usage conditions.

7. The Type of Ground Truth Used

Laboratory Reference Method: The primary and most frequently cited ground truth was the YSI 2300 STAT PLUS glucose analyzer.
Traceability: The YSI analyzer is traceable to the hexokinase method, which was developed collaboratively by the FDA, CDC, NIST, and AACC. This method utilizes NIST Standard Reference Material 917, dry D-glucose.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. Blood glucose meters typically do not involve "training sets" in the same way AI algorithms do unless specific machine learning components are involved (which is not described here). The development and calibration of such devices usually rely on extensive internal R&D test data and validated chemical/electrical principles, rather than a publicly reported "training set."

9. How the Ground Truth for the Training Set Was Established

As the document does not explicitly mention a training set in the context of an AI/ML model, it also does not describe how ground truth for such a set was established. Device calibration and internal validation would rely on the same laboratory reference methods described for the performance studies (e.g., YSI 2300 STAT PLUS traceable to hexokinase method).

Summary

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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 RoadTarrytown, NY 10591
Phone number	(914) 366-1800
Fax number	(914) 366-1899
EstablishmentRegistrationNumber	3003962513
Name of contactperson	Chuck Ryan
Date prepared	March 27, 2012
Name of device
Trade or proprietaryname	CONTOUR® LINK
Common or usualname	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 marketeddevice(s) to whichequivalence is claimed	CONTOUR Blood Glucose Meter (K062058)OneTouch UltraLink Blood Glucose Meter (K073231)
Reason for 510(k)submission	Addition of RF wireless transmission capability
Device description	The CONTOUR LINK Wireless Blood GlucoseMonitoring System features the CONTOUR LINKWireless Blood Glucose Monitor and the currentlymarketed CONTOUR Blood Glucose Test Strips, amongother components (e.g., lancing device, lancets andcontrol solution)
Intended use of the device	See Indications for Use below
Indications for use	The CONTOUR® LINK Wireless Blood GlucoseMonitoring System is an over the counter (OTC) deviceutilized by persons with diabetes in home settings for themeasurement of glucose in whole blood, and is forsingle-patient use only and should not be shared. TheCONTOUR® LINK Wireless Blood Glucose MonitoringSystem is indicated for use with fresh capillary wholeblood samples drawn from the fingertip only.CONTOUR® test strips are intended for self-testing bypersons with diabetes for the quantitative measurement
	of glucose in whole blood samples from 20 to 600mg/dL.
	The CONTOUR® LINK Wireless Blood GlucoseMonitoring System is intended to be used to transmitglucose values to Medtronic MiniMed Paradigm InsulinPumps or Medtronic MiniMed Paradigm REAL-TimeRevel Insulin Pumps through use of radio frequencycommunication.
	The CONTOUR® LINK Wireless Blood GlucoseMonitoring System is not intended for the diagnosis of orscreening for diabetes mellitus and is not intended foruse on neonates.
Summary of the Technological Characteristics of the New Device Compared toPredicate 1
SIMILARITIES to Predicate 1
Characteristic	New DeviceBayer's CONTOUR LINKmeter	Predicate 1Bayer's CONTOUR meterK062058
DetectionTechnology	Amperometric measurement ofblood 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
DIFFERENCES from Predicate 1
RFCommunicationProtocol	Transmits glucose values tocompatible MiniMed Paradigmand Guardian REAL Timedevices.	No RF capability
Alternative sitetesting	Fingertip only	Fingertip, palm or forearm
Measurementrange	20-600 mg/dL	10-600 mg/dL
Sample type	Capillary whole blood samplesonly. Not for use on neonates.	Capillary, venous, andarterial whole bloodsamples and neonatal bloodsamples
Hct range	20-65%	0-70%
Summary of the Technological Characteristics of the New Device Compared to Predicate 2
SIMILARITIES to Predicate 2
Characteristic	New DeviceBayer's CONTOUR LINKmeter	Predicate 2LifeScan OneTouchUltraLink meterK073231
DetectionTechnology	Amperometric measurement ofblood 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 DATASUMMARY OF NON-CLINICAL TESTS CONDUCTED FORDETERMINATION OF SUBSTANTIAL EQUIVALENCE

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Performance Test Summary-New Device

Characteristic

Results Summary

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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)Reference: 510(k) submission, Section 018-5
	Protocol: Fresh capillary blood was collected in the glucoserange distribution specified by ISO 15197 Section 7.3. Onehundred blood samples were tested using each of two CONTOURtest strip lots on two CONTOUR LINK meters for a total of 400readings. Samples were also tested in parallel on a YSI 2300STAT PLUS glucose analyzer.
	Acceptance Criteria: A minimum of 95 % of the individualglucose results shall fall within ± 15 mg/dL of the resultsobtained on the YSI analyzer at glucose concentrations < 75mg/dL, and within ± 20 % at glucose concentrations ≥75 mg/dL.
	Results: 98.7 % of the individual glucose results fell within ± 15mg/dL of the results obtained on the YSI analyzer at glucoseconcentrations < 75 mg/dL. 98.5% fell within ± 20 % at glucoseconcentrations ≥75 mg/dL.
Linearity/assayreportable range	Established in predicate submission (K062058).
	Reference: 510(k) submission, Section 018-7Two studies were conducted to establish the linearity of theCONTOUR system throughout the entire reportable range of 10 to600 mg/dL. In one study, blood with a hematocrit level of 40% wasadjusted to plasma glucose concentrations of 20, 30, 40, 50, and 60mg/dL and tested with three CONTOUR lots, 24 sensors per lot. Allresults fell within ±10mg/dL of the YSI reference value, satisfyingthe acceptance criteria.
	Reference Level,mg/dL	Mean,mg/dL	Bias,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.All results fell within ±20% at glucose level of 75 mg/dL andabove, and within ±15 mg/dL at glucose level below 75 mg/dL.This met the acceptance criteria.
Reference Level,mg/dL	Mean,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) istraceable to the hexokinase method developed collaboratively bythe FDA, CDC, NIST and AACC. The hexokinase method isincorporated in a Bayer procedure that utilizes NIST StandardReference Material 917, dry D-glucose. Glucose serum controlsfrom an outside supplier were characterized by Bayer using thehexokinase method as a reference. For each day that Bayer's YSIinstruments were used as the reference method, the serumcontrols were analyzed to ensure that the instruments were incontrol.
Detection limit	Established in predicate submission (K062058) as 10-600 mg/dL;stated in CONTOUR LINK specifications as 20-600 mg/dL dueto absence of neonatal claim.
Reference: 510(k) submission, Section 018-7The low glucose concentration testing conducted as part of theLinearity/Assay Reportable Range above confirmed detectionlimit. In addition, three production lots of CONTOUR sensorswere tested with whole blood samples manipulated to haveglucose concentrations of 5, 900, 1200, 1500 and 1800 mg/dL, 24sensors per samples. All readings of the 5 mg/dL samplesdisplayed "Lo" and all readings of 900 mg/dL or greaterdisplayed "Hi".
Analytical	Reference: 510(k) submission, Section 018-8; Response to

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specificity	First Additional Information Request
	The interference effects of several substances were evaluated perthe table below.
	Compound	AddedAmount	Signal ChangeCriterion at 80 and300 mg/dL glucose	Result
	Bilirubin	>20 mg/dL	≤10%	Passed
	Acetaminophen	>22 mg/dL	≤10%	Passed
	Uric Acid	>18 mg/dL	≤10%	Passed
	Ascorbic Acid	>30 mg/dL	≤10%	Passed
	Maltose	>200mg/dL	≤7%	Passed
	Galactose	>200mg/dL	≤7%	Passed
	Xylose	Interferes with test
Assay cut-off	Not applicable
COMPARATIVE PERFORMANCE INFORMATION SUMMARY
Methodcomparison withpredicate device(K062058)	Reference: 510(k) submission, Section 018-3Protocol: The CONTOUR and CONTOUR LINK meters weretested in a comprehensive fingerstick study using fresh capillaryblood samples. In this study, the RF function of the CONTOURLINK was left on to simulate real-world usage.Materials and MethodSamples from 111 subjects were collected by fingerstick andtested using two lots of CONTOUR sensors. Four CONTOURmeters were used, with disinfection between each subject.Plasma samples were tested in duplicate on the YSI referencemethod, with the average value used for the comparison.Hematocrit values also were measured. All measurements wereperformed at 23°C + 5°C.In most cases, samples were tested fresh from the finger withoutany modification. However, samples at very low and very highglucose concentrations were created by either glycolyzing aspecimen to lower the glucose concentration or supplementing aspecimen with a concentrated glucose solution to increase theglucose level.Acceptance Criteria:

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Image: Bayer logo
	Linearity/assay reportable range - comparison with predicate device (K062058)	A proportionally weighted Deming regression of the CONTOUR sensor data was used to calculate slope, intercept, and the 95% confidence interval around the slope and intercept estimates shall include a 1.0 and 0.0, respectively.Results:A total of 444 paired readings were collected. The plasma glucose range was 23 to 468 mg/dL, and the hematocrit range was 25% to 51.5%. A proportionally weighted Deming regression model was used to calculate slope and intercept estimates. The system performance meets the acceptance criteria.Slope: 0.989, confidence interval = 0.989 to 1.008Intercept: 0.49, confidence interval = -0.4 to 1.38 mg/dLReference: 510(k) submission, Section 018-2Protocol: Pooled fresh venous blood at plasma glucose concentrations of approximately 10, 45, 67, 134, 336, and 600 mg/dL were tested on eight CONTOUR LINK meters and eight CONTOUR meters with one lot of test strips. Each sample was tested three times on each meter, and a total of 24 readings were collected per system.Acceptance criteria:95% confidence interval width for the percent difference between CONTOUR LINK mean and CONTOUR mean is within ± 4% (± 3 mg/dL if glucose <75mg/dL) and includes ±1% (or ±0.75mg/dL). Imprecision of the CONTOUR® LINK system is not significantly larger (α = 0.05) than imprecision of the 5-second CONTOUR system or Cpk values are greater than 1.33. Results: Bias of the CONTOUR LINK system is not significantly larger than bias of the predicate CONTOUR system (K062058)
	SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
	Clinical study	Reference: 510(k) submission, Section 020,Protocol: The subject pool included 77 adults aged 20 through 85,

. .

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for use for self-testing, and the resulting accuracy of results, were assessed.

Results:

Statistical analysis of the data indicates that the probability exceeds 95% that a randomly selected person will successfully perform any of the tasks required for successful execution of the blood glucose testing procedure.

The accuracy study component of the protocol demonstrated that 95,5% of self-test results and 99.4% of HCP-test results satisfy ISO 15197 accuracy specifications (at least 95% of results must be within ±15 mg/dL at <75 mg/dL and ±20% at >75 mg/dL). All control solution test performed by subjects (77) generated inrange glucose values, and all were marked as controls by the meters.

Reference: Predicate 510(k) K062058

Protocol: The subject device is equivalent to the predicate CONTOUR® device with RF transmission capability added. The subject pool included 109 adults aged 20 through 75, each diagnosed with diabetes. The ability to follow instructions for use for self-testing, and the resulting accuracy of results, were assessed.

Results:

Ninety-nine percent of the subjects either did not require any assistance or required answers to questions in an interaction that was comparable to a Customer Service call.

Analytical accuracy of the subjects' self-testing was statistically indistinguishable from the laboratory glucose method. More than 96% were within the limits of ±15 mg/dL or ±20% of the laboratory glucose method, thus meeting the established performance criteria.

CONCLUSIONS/DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The performance of the CONTOUR® LINK Blood Glucose Monitoring System is equivalent to the performance of the previously cleared CONTOUR® Blood Glucose Monitoring System (K062058).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Bayer HealthCare LLC, Diabetes Care c/o Charles Ryan 777 Old Saw Mill River Road Tarrytown, NY 10591

MAR 2 8 2012

Re: K110587

Trade Name: CONTOUR® Link Wireless Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: LFR, NBW Dated: March 27, 2012 Received: March 28, 2012

Dear Mr. Ryan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number K110587:

Device Name: CONTOUR® LINK Wireless Blood Glucose Monitoring System

Indications for Use:

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 not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

ARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k1101587

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.