The CONTOUR® NEXT 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® NEXT LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The system consists of a Contour NEXT LINK Wireless Blood Glucose Meter, CONTOUR® NEXT Test Strips and CONTOUR® NEXT Control Solutions.

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 selftesting by people with diabetes as a quality control check.

The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit dlucose values to Medtronic MiniMed Paradigm Insulin pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed Paradigm® REAL-TIME Insulin Pumps or Guardian REAL-TIME Monitor and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication.

The CONTOUR® NEXT 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® NEXT LINK Wireless Blood Glucose Monitoring System consists of a small handheld electronic device is substantially equivalent in look and feel to the Contour® USB predicate system (K091820). The System also contains dry reagent strips and liquid controls to be used for the measurement of glucose in capillary whole blood by persons with diabetes. The System has the same automatic calibration as the predicate device. Blood glucose results are displayed on the meter window and stored in the meter's memory. The System is intended to transmit blood glucose results to compatible Medtronic Minimed insulin pumps. The RF function can also serve as a pass through for data being transmitted from Medtronic Minimed insulin pumps to Medtronic's Minimed PC based data management software.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Contour® NEXT LINK Wireless Blood Glucose Meter, extracted from the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Precision (Repeatability - ISO 15197 Section 7.2.2): Internal acceptance criteria are Cpk > 0.65 at all levels.	Pass: All Cpk's greater than 0.65.
Precision (Intermediate Precision - ISO 15197 Section 7.2.3): Internal acceptance criteria are Cp > 1.0 at all levels.	Pass: All Cp’s above 1.0.
Accuracy (System Accuracy - ISO 15197 Section 7.3): 95% of results within ±15 mg/dL for glucose < 75 mg/dL, and 95% of results within ±20% for glucose ≥ 75 mg/dL.	Pass for Contour NEXT reagent strips.- YSI Glucose < 75 mg/dL: 100% (51 of 51) within ±15 mg/dL.- YSI Glucose ≥ 75 mg/dL: 100% (249 of 249) within ±20%.
Linearity/Assay Reportable Range: Cpk ≥ 0.65 at all levels.	Pass: Values measured across the intended glucose measuring range.
Detection Limit (Extreme Glucose Levels): For blood with extreme glucose levels, the meter must display "Low" or "High" glucose error messages.	Pass: All extremely low and extremely high samples generated "Low" or "High" error messages as appropriate.
Analytical Specificity (Hematocrit): Mean difference from YSI reference values < 10 mg/dL or 10%.	Pass: At all Hct levels, the mean difference from the reference values met the acceptance criterion.
Analytical Specificity (Interfering Substances): Interfering substances should not have a significant effect on performance (except where noted, like ascorbic acid above 10 mg/dL causing +10% assay bias).	Pass: Interfering substances, except for ascorbic acid, did not have a significant effect. Ascorbic acid above 10 mg/dL can cause a +10% assay bias, but therapeutic range is lower.
RF Communication (BGM result to insulin pump): Medtronic pumps successfully receive values at 4 feet in 8 orientations; corrupted data recognized and not processed. Meter transmits BG values to receiving device at 4 feet at 916.5 MHz every 5 seconds for up to 12 attempts. Meter stops transmitting after receiving ACK or after 60 seconds without ACK. RF transmit feature can be turned On/Off. Meter has a 6-digit ID.	Pass: EMC testing confirmed no incorrect value was accepted or displayed by the pump per RF and product specifications.
Pass-through function (RF of pump data through BGM to PC): Meter, when connected to PC USB, enables communication between compatible Medtronic MiniMed device and PC for data/settings download to Medtronic data management software.	Pass: Data transfer and pass-through mode testing demonstrated successful operation.
Clinical Performance: 95% of results within ±20% (≥ 75 mg/dL) or within ±15 mg/dL (<75 mg/dL) of YSI results (for Contour NEXT LINK wireless meter using Contour NEXT reagent strips).	Pass.- Fingerstick: 100% (110 of 110) within ±15 mg/dL or 20%.- AST Palm: 97.3% (106 of 109) within ±15 mg/dL or 20%.

Study Information

Sample size used for the test set and the data provenance:
- Precision (Repeatability): Not explicitly stated as a "test set" in the context of patients, but involved 3 lots of Contour Next reagent strips and 10 Contour NEXT LINK wireless meters.
- Precision (Intermediate Precision): 3 levels of Contour NEXT control, 3 Contour NEXT strip lots, 10 Contour NEXT LINK wireless meters over 10 days.
- Accuracy (System Accuracy): 100 fresh capillary blood specimens. Data provenance is "Mishawaka site," implying an internal, likely prospective study.
- Linearity/Assay Reportable Range: Not explicitly stated as a patient "test set." Involved 3 lots of Contour Next reagent strips, 8 aliquots of venous blood pool, 24 replicates on eight meters for linearity. For low-end cutoff, blood adjusted to 15 mg/dL.
- Detection Limit: For low analytical range, 24 replicates on eight breadboard meters with glycolyzed 42% Hct whole blood samples at ~10, 15, and 20 mg/dL glucose. For extreme low/high, 8 meters tested with 72 reagent strips at 5 mg/dL, and 288 reagent strips at 900 mg/dL and above.
- Analytical Specificity (Hematocrit): Unspecified number of blood samples evaluated at 15, 20, 30, 42, 55, 65% Hct across various glucose concentrations, with 3 reagent strip lots on 5 Contour NEXT LINK wireless meters in triplicate. High altitude simulation used 2 reagent strip lots on 5 meters in duplicate.
- Analytical Specificity (Interfering Substances): Various substances tested, but no specific sample size for a "test set" is provided.
- RF Communication: N of 30 meter and pump pairs.
- Pass-through function: Not explicitly stated with a numerical sample size.
- Clinical Performance (Fingerstick): 110 adults (aged 19-86). Data provenance is a "clinical trial" which is typically prospective.
- Clinical Performance (AST Palm): 109 subjects. Data provenance is a "clinical trial" which is typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. For accuracy and clinical performance studies, the ground truth was established by a YSI™ glucose analyzer (Yellow Springs Instruments Stat Plus 2300 analyzer). The YSI is traceable to the hexokinase method, which is a recognized reference method. This is a laboratory instrument, not human experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth was established by a reference laboratory instrument (YSI glucose analyzer), not by human interpretation or consensus.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is a blood glucose meter, and its performance is evaluated against a reference standard (YSI glucose analyzer), not against human reader interpretations. There is no AI component mentioned in the context of human assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance of the device itself (the blood glucose meter system) was evaluated in standalone mode against the YSI reference method for accuracy and clinical performance. The results reported in the tables reflect the algorithm's performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for glucose measurements (Accuracy and Clinical Performance) was established by the YSI™ glucose analyzer, which is a laboratory reference method. For other technical aspects like detection limits and RF communication, ground truth or acceptance was based on predefined technical specifications and error messages.
The sample size for the training set:
- The document describes performance testing and clinical trials directly. It does not provide information about a separate "training set" in the context of machine learning. The studies described are for validation of the device's performance.
How the ground truth for the training set was established:
- Not applicable, as a machine learning "training set" is not mentioned or described in the provided regulatory summary.

Summary

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K110894

MAR 2 8 2012

510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements
of 21

Submitter Information
Name	Bayer Healthcare, Diabetes Care
Address	430 S Beiger StMishawaka IN 46544
Phone number	574-256-3441
Fax number	547-256-3519
Establishment Registration Number	1826988
Name of contact person	Roger Sonnenburg
Date prepared	3/26/2012
Trade or proprietary name	Contour® NEXT LINK Wireless Blood Glucose Meter
Common or usual name	Blood Glucose Meter
Classification name	75 LFR Glucose Dehydrogenase, Glucose
Classification panel	Clinical Chemistry and Toxicology
Regulation	21 CFR 862.1345
Product code(s)	LFR (Glucose Dehyrogenase, Glucose), NBW (System, Test, Blood Glucose, Over The Counter)
Legally marketed device(s) to which equivalence is claimed	Predicate 1 Contour USB (K091820), Predicate 2 One Touch Ultralink (K073231), Predicate 3 Care Link USB (K070438)
Reason for 510(k) submission	This submission reports a modification of the Contour USB meter (K091820). This modification includes the ability to read a new reagent strip and wireless transmission capabilities with compatible Medtronic Minimed devices
Device description	The Contour® NEXT LINK Wireless Blood Glucose Monitoring System consists of a small handheld electronic device is substantially equivalent in look and feel to the Contour® USB predicate system (K091820). The System also contains dry reagent strips and liquid controls to be used for the measurement of glucose in capillary whole blood by persons with diabetes. The System has the same automatic calibration as the predicate device. Blood glucose results are displayed on the meter window and stored in the meter's memory. The

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	software.	results to compatible Medtronic Minimed insulin pumps. The RF function canalso serve as a pass through for data being transmitted from MedtronicMinimed insulin pumps to Medtronic's Minimed PC based data management
Intended use of thedevice	See indications for use below
Indications for use		The CONTOUR® NEXT LINK wireless blood glucose monitoring system is an over thecounter (OTC) device utilized by persons with diabetes in home settings for themeasurement of glucose in whole blood, and is for single-patient use only and shouldnot be shared. The CONTOUR® NEXT LINK wireless blood glucose monitoring systemis indicated for use with fresh capillary whole blood samples drawn from the fingertipand palm only. The system consists of a Contour NEXT LINK wireless blood glucosemeter, CONTOUR® NEXT test strips and CONTOUR® NEXT control solutions.
	CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes forthe quantitative measurement of glucose in whole blood samples from 20 to 600mg/dl
	The CONTOUR® NEXT control solutions are aqueous glucose solutions intended foruse in self-testing by people with diabetes as a quality control check.
	use of radio frequency communication.	The CONTOUR® NEXT LINK wireless blood glucose monitoring system is intended tobe used to transmit glucose values to Medtronic MiniMed Paradigm Insulin pumps orMedtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMedParadigm® REAL-TIME Insulin Pumps or Guardian REAL-TIME and facilitate transferof information to Medtronic MiniMed Carelink Therapy Management Software through
	neonates.	The CONTOUR® NEXT LINK wireless blood glucose monitoring system is not intendedfor the diagnosis of or screening for diabetes mellitus and is not intended for use on
	1. 13. 2. 13. 1	nological Characteristics of the New Device Compared to Pre
	Similarities to Predicate 1
Characteristic	Predicate 1	New Device
	Contour USB K091820	Contour NEXT LINK Wireless
Blood sample volumeMeal markers	0.6ul	Same as predicate
Automatic calibration	YesYes	Same as predicateSame as predicate
Communication port	USB	Same as predicate
User interface	Alphanumeric, Iconic, NativeLanguage	Same as predicate
Display (technology)	Graphical (OLED)	Same as predicate
Display visibility	Day & Night	Same as predicate
Illuminated strip port	Yes	Same as predicate
Operational buttons	4	Same as predicate
Battery type	Rechargeable (3.4-4.2V)	Same as predicate

Communication Link toComputerDisplayed countdown	Direct USB Connection oroptional USB Cable5 seconds	Same as predicateSame as predicate
Characteristic	Predicate 1Contour USB K091820	New DeviceContour NEXT LINK Wireless
Control solution ranges	Low/Normal/High	Level 1/Level 2
Control solution bufferconcentration	50-100 mM	22 mM
Reagent stripcompatibility	Only compatible with Contourreagent strip	Only compatible with Contour NEXTreagent strip
Total test time ContourNEXT reagent strip	N/A	7 Seconds
Software systemrequirements	Windows:XP,SP3,Vista SP2, 7;MAC OS 10.6.3,10.5.8;Java 1.6.0_07 or higher, Highpower USB port	High power USB port
Double dip functionContour NEXT reagentstrip	N/A	Yes
Indications for Use	Cleared for home andprofessional use and fingertip,palm and forearm sampling.	Intended for home use, single patient useonly fingertip and palm sampling only.RF Capability to communicate withcompatible insulin pumps and act as adata pass through between insulin pumpsand data management software (seeIndications for Use section).
Test memory	2000 results	1000 results
User accessible datastorage	Yes (500MB)	No
Data managementsoftware application on-	Yes	No

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. . . . . . .

the contraction of the country of

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Summary of the Technological Characteristics of the New Device Compared to Predicate 2 (One Touch Ultralink K073231) - - - - - - -Similarities to Predicate 2 Predicate 2 New Device

Characteristic	One Touch Ultralink	Contour NEXT LINK Wireless
Communication	Ability to communicate withcompatible insulin pump via RF	Same as predicate
Frequency	916.5 MHz	Same as predicate
Differences from Predicate 2
Characteristic	Predicate 2One Touch Ultralink	New DeviceContour NEXT LINK Wireless
Userconfirmationregardingsending via RFof BGM result	RF on, RF off	RF on, RF off and RF prompt

Summary of the Technological Characteristics of the New Device Compared to Predicate 3 (Care Link USB K070438) - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1

Characteristic	Predicate 3Care Link USB	New DeviceContour NEXT LINK Wireless
Pass throughfunction	Yes	Same as predicate

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Performance Test Summary-New Device

Performance Test Summary-New Device
Characteristic	Results Summary
Precision	Repeatability (ISO 15197 Section 7.2.2)Reference: 510(k) submission, Section Labeled Performance Testing BenchProtocol: The repeatability of the CONTOUR NEXT LINK wireless blood glucose monitoringsystem was tested at glucose levels of 38, 78, 122, 204 and 326 mg/dL. Three lots of ContourNext reagent strips were tested across 10 Contour NEXT LINK wireless meters.Acceptance Criteria: No ISO criteria stated. Internal acceptance criteria are $Cpk > 0.65$ at alllevels. (Cpk is difference between the mean result and the nearest limit, divided by 3 standarddeviations.)Results: Pass, All Cpk's greater than 0.65.
	Intermediate Precision (ISO 15197 Section 7.2.3)Reference: 510(k) submission, Section Labeled Performance Testing BenchProtocol: The intermediate precision of the CONTOUR® NEXT LINK wireless blood glucosemonitoring system was determined using three levels of Contour NEXT control on threeContour NEXT strip lots on 10 Contour NEXT LINK wireless meters over the course of 10days.Acceptance Criteria for Contour reagent strips: No ISO criteria stated. Internal acceptancecriteria are $Cp > 1.0$ at all levels. (Cp is the tolerance range divided by 6 standard deviations.)Acceptance Criteria for Contour NEXT reagent strips: Internal acceptance criteria are $Cp > $1.0 at all levelsResults: Pass. All Cp’s above 1.0

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Accuracy	System Accuracy Evaluation (ISO 15197 Section 7.3)Reference: 510(k) submission, Section Labeled Performance Testing BenchProtocol: The accuracy of the CONTOUR®NEXT LINK wireless blood glucose monitoringsystem was assessed using 100 fresh capillary blood specimens that were collected during afingerstick study at the Mishawaka site. The blood samples were tested using threeCONTOUR® NEXT reagent lots, 10 vials per lot to yield 300 results. The referencemeasurement was done on a YSI™ glucose analyzer.Acceptance Criteria: 95% ± 15 mg/dL < 75 mg/dL, 95% ± 20% ≥ 75 mg/dLResults: Pass for Contour NEXT reagent strips.

	Summary of Results for Contour Next reagent strips on Contour Next Link Wireless Meter:
	Results within:	±5mg/dL	±10mg/dL	±15mg/dL
	YSI Glucose <75 mg/dL	48 of 51 (94.1%)	51 of 51 (100%)	51 of 51 (100%)
	Results within:	±5%	±10%	±15%	±20%
	YSI Glucose ≥75 mg/dL	212 of 249 (85.1%)	247 of 249 (99.2%)	249 of 249 (100%)	249 of 249 (100%)
Linearity/assay reportable range	For Contour reagent strip, established in current Predicate (K091820) and previous Contour systemsReference: 510(k) submission, Section Labeled Performance Testing BenchProtocol: A linearity study was performed with three lots of Contour Next reagent strips. Afresh venous blood pool was divided into eight aliquots and glycolyzed at room temperature orsupplemented with a glucose stock solution to produce whole blood samples with plasmaacross the intended glucose measuring range. The evaluation included 24 replicates on eightmeters. In addition, all three reagent strip lots were tested with a blood pool adjusted to 15mg/dL per the YSI reference, using meters with the low-end cutoff disabled.Acceptance Criteria: Cpk ≥ 0.65 at all levelsResults: Pass, Values measured across the intended glucose measuring range
Traceability	The Yellow Springs Instruments Stat Plus 2300 analyzer (YSI) is traceable to the hexokinasemethod developed collaboratively by the FDA, CDC, NIST and AACC. The hexokinasemethod utilizes NIST Standard Reference Material 917b, dry D-glucose. For the YSIqualification, six-level serum controls were assayed on six different YSI analyzers over a one-month period. Each day that YSI instruments were used as the reference method, the serumcontrols were analyzed to ensure that the instruments were in control.Summary of Results: Pass, Results within limits

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Detection limit	Established in current Predicate (K091820) and previous Contour systemsReference: 510(k) submission, Section Labeled Performance Testing Bench
	Protocol: To ensure that the performance of Contour NEXT LINK wireless blood glucosesystem is acceptable at glucose concentrations near the low end of the analytical range, thethree clinical trial lots were evaluated with glycolyzed 42% Hct whole blood samples atapproximately 10, 15, and 20mg/dL glucose. The study was done by collecting 24 replicateson eight breadboard meters which did not have the low limit set.
	In addition, the system was tested with blood adjusted to extremely low and extremelyhigh glucose levels of 5, 900, 1200, 1500 and 1800 mg/dL. Eight meters were tested with atotal of 72 reagent strips at 5 mg/dL, and 288 reagent strips at 900 mg/dL and above.Acceptance Criteria:
	For blood with extreme glucose levels, the acceptance criterion is for the meter to display"Low" or "High" glucose error messages.
	Results: Pass. All extremely low and extremely high samples generated "Low" or "High"error messages as appropriate.
Analyticalspecificity	The effect of changing hematocrit was evaluated at 15, 20, 30, 42, 55 and 65% Hct at bloodglucose concentrations of 40, 90, 127 and 329 and 450 mg/dL for three reagent strip lots on 5Contour NEXT LINK wireless meters in triplicate.
	A high altitude simulation study was also performed which evaluated 15, 41 and 65 % Hct atblood glucose concentrations of 40, 90 and 450 mg/dL for two reagent strip lots on 5 ContourNEXT LINK wireless meters in duplicate.
	The acceptance criterion was <10 mg/dL or 10% mean difference from the YSI referencevalues.
	The following interfering substances were tested: hematocrit, ascorbic acid, bilirubin, uric acid,maltose, galactose
	Other exogenous interfering substances were also tested, such as cholesterol, creatinine,dopamine, etc.
	Summary of Results for hematocrit (Contour NEXT reagent) :
	At all Hct levels, the mean difference from the reference values met the acceptance criterion.
	Summary of Results for interfering substances (Contour NEXT reagent) :
	Interfering substances, except for ascorbic acid, did not have a significant effect onperformance.
	Ascorbic acid above 10 mg/dL can cause a +10% assay bias. The high end of the therapeuticrange for ascorbic acid is 2 mg/dL.
Assay cut-off	Not applicable

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RF of BGMresult toinsulin pump	Protocol: Electromagnetic compatibility testing was performed that included interferences; cellphone, metal detectors, EAS immunity and household emitter immunity. (N of 30 meter andpump pairs)Acceptance criteria: Medtronic pumps were required to successfully receive the valuestransmitted by the Contour NEXT LINK wireless system at a distance of 4 feet with the pump ineight different orientations. In the event there is interruption of RF Communication, anycorrupted data shall be recognized and not processed. Testing was performed against RFspecifications(ES9411) and product specifications (ES10255). This included the following:Assuring the meter transmitted blood glucose values in the mg/dL to the receivingdevice at 4 feet at 916.5 MHz every 5 seconds for up to 12 attemptsMeter stopped transmitting after it successfully received ACK from the receivingdevice, and the meter stopped transmitting after 60 seconds if an ACK was notreceived.Meter is capable to turn RF transmit feature On or OFF and if RF transmit featureOFF, meter will still display BG value but does not transmit BG value.Meter has a 6 digit ID numberResults: EMC testing with various interferences confirmed that in no case was an incorrectvalue accepted or displayed by the pump per RF and product specifications.
Pass throughfunction (RF ofpump datathrough BGMto PC baseddatamanagementsoftware whenconnected toPC USB port)	Protocol: Testing was performed that assured the Contour NEXT LINK wireless meter, whenconnected to a PC USB port, enabled communications between the compatible MedtronicMiniMed device and a PC for the purpose of allowing meter data and settings to bedownloaded to Medtronic data management software.Acceptance criteria: Testing was performed against RF specifications (ES9411) and productspecifications (ES10255).Results: Data transfer and pass-through mode testing demonstrated successful data transferoperation for the pass through mode.

RF of BGMresult toinsulin pump

Protocol: Electromagnetic compatibility testing was performed that included interferences; cellphone, metal detectors, EAS immunity and household emitter immunity. (N of 30 meter andpump pairs)Acceptance criteria: Medtronic pumps were required to successfully receive the valuestransmitted by the Contour NEXT LINK wireless system at a distance of 4 feet with the pump ineight different orientations. In the event there is interruption of RF Communication, anycorrupted data shall be recognized and not processed. Testing was performed against RFspecifications(ES9411) and product specifications (ES10255). This included the following:Assuring the meter transmitted blood glucose values in the mg/dL to the receivingdevice at 4 feet at 916.5 MHz every 5 seconds for up to 12 attemptsMeter stopped transmitting after it successfully received ACK from the receivingdevice, and the meter stopped transmitting after 60 seconds if an ACK was notreceived.Meter is capable to turn RF transmit feature On or OFF and if RF transmit featureOFF, meter will still display BG value but does not transmit BG value.Meter has a 6 digit ID numberResults: EMC testing with various interferences confirmed that in no case was an incorrectvalue accepted or displayed by the pump per RF and product specifications.

Pass throughfunction (RF ofpump datathrough BGMto PC baseddatamanagementsoftware whenconnected toPC USB port)

Protocol: Testing was performed that assured the Contour NEXT LINK wireless meter, whenconnected to a PC USB port, enabled communications between the compatible MedtronicMiniMed device and a PC for the purpose of allowing meter data and settings to bedownloaded to Medtronic data management software.Acceptance criteria: Testing was performed against RF specifications (ES9411) and productspecifications (ES10255).Results: Data transfer and pass-through mode testing demonstrated successful data transferoperation for the pass through mode.

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SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION
ClinicalPerformanceData/Information	Reference: 510(k) submission, Section Labeled Clinical TrialsProtocol for Contour NEXT LINK wireless meters using Contour NEXT reagent strips:The Contour NEXT wireless blood glucose monitoring system clinical trial included 110 adultsaged 19-86. 88% of the subjects managed their diabetes at home with insulin.Three lots of reagent were tested in the study with each subject randomized to one lot. Eachsubject performed one fingerstick self test, followed by testing of the subject's blood by the studystaff. Subjects also performed AST self tests on the palm. All meter results were compared tothe YSI reference results.Acceptance Criteria for Contour NEXT LINK wireless meter using Contour NEXT reagentstrips:95% of results within ±20% (≥ 75 mg/dL) or within ±15 mg/dL (<75 mg/dL) of YSI results
Clinical trial results for Contour®Next Link Wireless System
Clinical Trial Results for Contour®Next Link Wireless - Contour®Next Strips:Fingerstick 110 results: 110 subjects, 1 lot per subject, 3 lots overall
	Resultswithin:	±5 mg/dL	±10 mg/dL	±15 mg/dL	±20 mg/dL
	YSI Glucose<75 mg/dL	8 of 8 (100%)	8 of 8 (100%)	8 of 8(100%)	8 of 8 (100%)
	Resultswithin:	±5%	±10%	±15%	±20%
	YSI Glucose≥75 mg/dL	82 of 102(80.4%)	101 of 102(99.0%)	101 of 102(99.0%)	102 of 102 (100%)
	Resultswithin:	±5 mg/dL or5%	±10 mg/dL or10%	±15 mg/dLor 15%	±15 mg/dL or 20%
	Total	90 of 110(81.8%)	109 of 110(99.1%)	109 of 110(99.1%)	110 of 110(100%)
Clinical Trial Results for Contour®Next Link Wireless - Contour®Next Strips: AST Palm109 results: 109 subjects, 1 lot per subject, 3 lots overall
	Resultswithin:	±5 mg/dL	±10 mg/dL	±15 mg/dL	±20 mg/dL
	YSI Glucose<75 mg/dL	6 of 7 (85.7%)	7 of 7 (100%)	7 of 7(100%)	7 of 7 (100%)
	Resultswithin:	±5%	±10%	±15%	±20%
	YSI Glucose≥75 mg/dL	61 of 102(59.8%)	90 of 102(88.2%)	98 of 102(96.1%)	99 of 102(97.1%)
	Resultswithin:	±5 mg/dL or5%	±10 mg/dL or10%	±15 mg/dLor 15%	±15 mg/dL or 20%
	Total	67 of 109(61.5%)	97 of 109(89.0%)	105 of 109(96.3%)	106 of 109(97.3%)

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The performance of the Contour NEXT LINK Wireless Blood Glucose Monitoring System is substantially equivalent to the performance of the previously cleared Contour USB Blood Glucose Monitoring System (K091820), One Touch Ultralink (K073231) and Care Link USB (K070438).

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three human figures, representing the department's focus on people and their well-being.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Bayer HealthCare LLC, Diabetes Care c/o Roger Sonnenburg 430 South Beiger St Mishawaka, IN 46544

MAR 2 8 2012

K110894 Re:

Trade Name: CONTOUR® NEXT 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,JJX Dated: March 27, 2012 Received: March 28, 2012

Dear Mr. Sonnenburg:

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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Page 2

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 K110894:

Device Name: Contour® NEXT LINK Wireless Blood Glucose Monitoring System

Indications for Use:

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 selftesting by people with diabetes as a quality control check.

The CONTOUR® NEXT 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 × (21 CFR Part 801 Subpart D) And/Or

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

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

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

510(k) K110844

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.