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 Description

The Contour NEXT EZ Blood Glucose Monitoring System consists of:

Contour NEXT EZ Blood Glucose Meter
Contour NEXT Blood Glucose Test Strips
Contour NEXT Control Solutions

AI/ML Overview

Acceptance Criteria and Device Performance Study for Contour NEXT EZ Blood Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Accuracy	Non-clinical (ISO 15197 Section 7.3/7.4.1): A minimum of 95% of individual glucose results to fall within ±15 mg/dL of YSI analyzer results at glucose < 75 mg/dL, and within ±20% at glucose ≥ 75 mg/dL.	Non-clinical: 100% of data fell within ±20% or ±15 mg/dL. More precisely, 100% within ±10 mg/dL (<75mg/dL) and 99.2% within ±10% (≥ 75 mg/dL).

	Clinical (ISO 15197:2003 Section 8 internal criteria): 95% of individual glucose results to fall within ±15 mg/dL of manufacturer's method results at glucose < 75 mg/dL, and within ±20% at glucose ≥ 75 mg/dL.	Clinical: 100% of results meet the above accuracy requirements. More precisely, 100% within ±10 mg/dL (<75 mg/dL) and 96.3% within ±10% (≥ 75 mg/dL).
Precision (Repeatability)	Internal Acceptance Criterion: Repeatability test must perform within the established accuracy requirements of Cpk ≥ 0.65.	All Cpk values were greater than 0.65, ranging from 3.7 to 5.9 across different glucose intervals.
Linearity/Reportable Range	System Linearity: (1) At least 95% of assay results within ±10% for samples ≥100 mg/dL or within ±10 mg/dL for samples <100 mg/dL relative to YSI plasma glucose values. (2) Linear regression slope from 0.93 to 1.07, intercept from -8.9 to +9.4, correlation coefficient > 0.990.	100% of 717 data points were within ±10 mg/dL (<100mg/dL) or ±10% (≥100mg/dL) of YSI reference. Regression equation: y = 0.967(x) + 1.246 (slope and intercept within range), r = 0.998 (>0.990).
Detection Limit	For blood with extreme glucose levels, the meter must display "LO" or "HI" error messages.	All 72 readings at 5 mg/dL reported "LO", and all 288 readings at 900 mg/dL and higher reported "HI". Pass.
Analytical Specificity (Hematocrit)	Assay bias within 10 mg/dL (glucose <100mg/dL) or 10% (glucose ≥100mg/dL) compared to YSI references or 40% Hct whole blood samples. No trend of increasing imprecision or bias with increasing hematocrit.	Results indicate assay bias is within the specified limits. No trend of increasing imprecision or bias with increasing sample hematocrit.

2. Sample Size Used for the Test Set and Data Provenance

Non-clinical Accuracy Study:

Sample Size: 100 blood samples tested in replicates, resulting in 300 data points for the first replicate (6 meters x 3 lots x ~16 samples/lot, adjusted to 100 samples total).
Data Provenance: Not explicitly stated, but implies laboratory-controlled and prepared blood samples.

Clinical Accuracy Study:

Sample Size: 115 subjects.
Data Provenance: Clinical site, fresh fingertip capillary blood samples (prospective study).

Precision (Repeatability) Study:

Sample Size: Venous blood tested at five glucose concentration ranges. 10 meters, 10 replicates per meter for one test strip lot (n=100 for each blood sample level, total unknown but implies 500 data points across 5 intervals).
Data Provenance: Not explicitly stated, but implies laboratory-controlled venous blood.

Linearity/Reportable Range Study:

Sample Size: Eight aliquots of fresh venous blood, each at a different glucose concentration. 30 replicate data points per aliquot for each of three test strip lots (8 glucose levels * 30 replicates * 3 lots = 720 data points, with 717 used for analysis after removing data >600mg/dL).
Data Provenance: Laboratory-controlled fresh venous blood.

Detection Limit Study:

Sample Size: 8 Contour meters (3 readings per meter) with 3 test strip lots; 72 readings for low glucose (5 mg/dL) and 288 readings for high glucose (900-1800 mg/dL).
Data Provenance: Not explicitly stated, but implies laboratory-controlled blood samples.

Analytical Specificity (Hematocrit) Study:

Sample Size: Fresh venous blood samples (15% to 65% hematocrit), adjusted to two plasma glucose concentrations (40 mg/dL and 550 mg/dL). 12 replicates per sample collected on six Contour NEXT meters for each of three test strip lots.
Data Provenance: Laboratory-controlled fresh venous blood samples.

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

Ground Truth Method: The ground truth for all performance studies (Accuracy, Precision, Linearity, Detection Limit, Analytical Specificity) was established by comparison to the YSI 2300 STAT PLUS glucose analyzer.
Expert involvement: The document does not specify direct involvement of human "experts" to establish the ground truth for individual test set samples. Instead, the YSI appliance serves as the reference standard. The traceability section states the YSI analyzer is traceable to the hexokinase method, which was developed collaboratively by the FDA, CDC, NIST, and AACC. This implies expert validation of the reference method, rather than individual sample adjudication by experts.

4. Adjudication Method for the Test Set

None specified for individual samples. The YSI 2300 STAT PLUS glucose analyzer provided a single reference value for each blood sample, acting as the definitive ground truth. There was no mention of multiple expert reads or an adjudication process for discrepancy resolution for the test samples themselves.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was described. The studies focused on the performance of the device itself against a reference standard or internal criteria. The clinical study involved users self-testing, but it was not designed as an MRMC study to compare human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance was done. The "Accuracy" section under "Performance Data" describes "System Accuracy Evaluation" where "Six Contour NEXT EZ meters, three lots of test strips and 100 blood samples were tested in replicates." The reported results are directly from the device's measurement compared to the YSI reference, indicating standalone algorithm performance. Similarly, all other non-clinical studies (Precision, Linearity, Detection Limit, Analytical Specificity) evaluate the inherent performance of the device's system and algorithm.

7. Type of Ground Truth Used

YSI 2300 STAT PLUS glucose analyzer results. This is stated to be traceable to the hexokinase method, which is a recognized laboratory reference method for glucose measurement. The hexokinase method itself is "incorporated in a Bayer procedure that utilizes NIST Standard Reference Material 917, dry D-glucose." This indicates a highly accurate and standardized laboratory reference.

8. Sample Size for the Training Set

Not explicitly stated. The document is a 510(k) summary for a blood glucose monitoring system, which typically relies on established electrochemical principles rather than machine learning algorithms that require large training sets in the same way AI-powered image analysis tools do. The "measurement algorithm" was modified, but the detail on its development and any associated "training set" (in the sense of machine learning) is not provided in this summary. Instead, the focus is on verification and validation studies using test sets.

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

Not applicable/Not explicitly stated in the context of machine learning training data. As mentioned above, the device likely relies on a deterministic algorithm for glucose measurement based on electrochemical detection. Therefore, the concept of a "training set" with established ground truth as used in machine learning is not directly addressed. The device is verified and validated against established laboratory reference methods and internal criteria.

Summary

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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 StreetMishawaka IN46544USA
Phone number	(574) 257-3075
Fax number	(574) 256-3519
EstablishmentRegistrationNumber	1826988
Name of contactperson	Weiping Zhong
Date prepared	February 24 2012
Name of device
Trade orproprietary name	Contour® NEXT EZ Blood Glucose Monitoring System
Common or usualname	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 Monitoring System (K062058)
Reason for 510(k)submission	Modified test strips and measurement algorithm
Device description	The Contour NEXT EZ Blood Glucose MonitoringSystem consists of:1. Contour NEXT EZ Blood Glucose Meter2. Contour NEXT Blood Glucose Test Strips3. Contour NEXT Control Solutions
Intended use of thedevice	The Contour NEXT EZ Blood Glucose MonitoringSystem is intended to measure the glucoseconcentration in whole blood.
Indications for use	The CONTOUR NEXT EZ blood glucose monitoringsystem is an over the counter (OTC) device utilized forself-testing by persons with diabetes at home for thequantitative measurement of glucose in whole blood, isfor single-patient use only, and should not be shared.The CONTOUR NEXT EZ blood glucose monitoringsystem is indicated for use with fresh fingertip capillarywhole blood samples. The clinical utility of this deviceis to aid in monitoring the effectiveness of your diabetescontrol program.The CONTOUR NEXT EZ blood glucose monitoringsystem is not intended for use for the diagnosis of orscreening for diabetes mellitus and is not intended foruse on neonates.The CONTOUR NEXT test strips are intended for self-testing by persons with diabetes for the quantitativemeasurement of glucose in whole blood samples from20 to 600 mg/dL.The CONTOUR NEXT control solutions are aqueousglucose solutions intended for use in self-testing bypeople with diabetes as a quality control check.
Summary of the Technological Characteristics ofthe New Device Compared to Predicate
SIMILARITIES to Predicate
Characteristic	PredicateContour (K062058)	Contour NEXT EZ(Candidate Device)
Blood SampleVolume	$0.6\mu L$	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)(or DL2032)	Same as predicate
Displayed CountdownTime	5 seconds	Same as predicate
Detection Technology	Amperometric measurementof 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
DIFFERENCES from Predicate
Characteristic	PredicateContour (K062058)	Contour NEXT EZ(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• Venous whole blood samples• Arterial whole blood samples• 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	NoInadequate sample volume results in error message	YesSystem 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 FORDETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
Characteristic	Results Summary
Accuracy	System Accuracy Evaluation (ISO 15197 Section 7.3/7.4.1)Reference: 510(k) submission, Section – 001_015 SystemAccuracy (Book Additional Information 2)Protocol: Six Contour NEXT EZ meters, three lots of test strips and100 blood samples were tested in replicates. The first replicate (atotal of three hundred data points) was analyzed. Samples were alsotested in parallel on a YSI 2300 STAT PLUS glucose analyzer asreference valuesAcceptance Criteria: A minimum of 95 % of the individual glucoseresults shall fall within ± 15 mg/dL of the results obtained on the YSIanalyzer at glucose concentrations < 75 mg/dL, and within ± 20 % atglucose concentrations ≥75 mg/dL.Results: All data (100%) fell within ±20% or ±15 mg/dL of thelaboratory comparison method. Further, the data show an improvedaccuracy in that 100% of test results fall within ±10 mg/dL(<75mg/dL) and 99.2% fall within ±10% (≥ 75 mg/dL) of thelaboratory comparison method.
	Resultswithin:	±5 mg/dL	±10 mg/dL	±15 mg/dL
	YSI Glucose<75 mg/dL	49 of 51(96.1%)	51 of 51(100%)	51 of 51(100%)
	Resultswithin:	±5%	±10%	±15%	±20%
	YSI Glucose ≥75 mg/dL	203 of 249(81.5%)	247 of 249(99.2%)	249 of 249(100%)	249 of 249(100%)
	Resultswithin:Total	±5 mg/dLor 5%252 of 300(84%)	±10 mg/dLor 10%298 of 300(99.3%)	±15 mg/dLor 15%300 of 300(100%)	±15 mg/dLor 20%300 of 300(100%)
Precision	Repeatability (ISO 15197 Section 7.2.2)Reference: 510(k) submission, Section Labeled PerformanceTesting - BenchProtocol: Venous blood was tested at five glucose concentrationranges: 30-50, 51-110, 111-150, 151-250 and 251-400mg/dL. Twooperators tested one lot of test strips on 10 meters with 10 replicates per

. . .

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	meter (n=100).
	Acceptance criteria: No ISO acceptance criterion established. Theinternal acceptance criterion was: Repeatability test must performwithin the established accuracy requirements of Cpk ≥ 0.65 (Cpk isdifference between the mean result and the nearest limit, divided by3 standard deviations.)
	Results: The following results show that all the Cpk values are greaterthan 0.65.
	Interval1 (30-20)2 (51-110)3 (111-150)4 (151-250)5 (251-400	GrandMean47.384.2138.5201.5326.3	PooledSD0.81.12.12.65.0	95% Cl ofSD0.7-0.91.0-1.21.9-2.32.4-2.94.6-5.5	PooledVariance0.61.34.37.025.1	Pooled%CV1.71.31.51.31.5	СрК5.94.64.14.53.7
Linearity/assay	Reference: 510(k) submission, Section 001_003 Linearity withTruncated Data (Book Additional Information 2)
reportablerange	Protocol: Eight Contour NEXT EZ meters and three lots of ContourNEXT sensors (CT1, CT2, and CT3) are used to demonstrate theanalytical range of the assay from 20 to 600mg/dL glucose. A freshvenous blood pool at 42% Hct was divided into eight aliquots andadjusted to plasma glucose concentrations at 21, 31, 104, 157, 312,449, 574 and 607 mg/dL. The precision and linearity evaluation wasdone by collecting 30 replicate data points. Results from the ContourNEXT EZ System were compared to the YSI testing results. The dataabove 600mg/dL was removed from analysis.Acceptance criteria: The acceptance criteria used for systemlinearity specify that (1) at least 95% of the assay results fall within±10% for samples with glucose ≥100mg/dL or within ±10mg/dL forsamples with glucose <100mg/dL relative to YSI plasma glucosevalues, and (2) the linear regression slope ranges from 0.93 to 1.07and intercept ranges from -8.9 to +9.4 with correlation coefficientgreater than 0.990.
	Results: The linear regression analysis shows the acceptance criteriaare met. Out of the 717 data points, 717 data points (100%) arewithin ±10mg/dL (for samples with glucose <100mg/dL) or within±10% (for samples with glucose ≥100mg/dL) of the YSI reference.There is a good fit between the Contour NEXT EZ and the YSItesting and the slope and interception are within the specified ranges.
	Regression equation95% Confidence Interval of Slope95% Confidence Interval of InterceptrSyx			તે 86	y = 0.967(x) + 1.2460.964 to 0.9700.084 to 2.4080.998

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Traceability	Reference: 510(k) submission, Section Labeled PerformanceTesting - Bench
	Contour NEXT EZ System are referenced to the Yellow SpringsInstruments Stat Plus 2300 analyzer (YSI), which is traceable to thehexokinase method developed collaboratively by the FDA, CDC,NIST and AACC. The hexokinase method is incorporated in aBayer procedure that utilizes NIST Standard Reference Material 917,dry D-glucose. Glucose serum controls from an outside supplierwere characterized by Bayer using the hexokinase method as areference. For each day that Bayer's YSI instruments were used asthe reference method, the serum controls were analyzed to ensurethat the instruments were in control.
Detectionlimit	Reference: 510(k) submission, Section Labeled PerformanceTesting - Bench
	In addition to the linearity study demonstrating that accurate readingsare obtained throughout the reportable range between 20 and 600mg/dL, the system was also tested with extremely low glucose (5mg/dL) and extremely high glucose (900, 1200, 1500, and 1800mg/dL) to ensure that the Contour NEXT meter correctly reports"LO" and "HI" messages. Eight Contour meters (3 readings permeter) were tested with three test strip lots. All 72 readings obtainedwith blood adjusted to 5 mg/dL glucose reported "LO", and all 288readings obtained with blood adjusted to 900 mg/dL and higherreported "HI".
	Acceptance Criteria: For blood with extreme glucose levels, theacceptance criterion is for the meter to display "LO" or "HI" glucoseerror messages.
	Results: Pass. All extremely low and extremely high samplesgenerated "LO" or "HI" error messages as appropriate.
Analyticalspecificity	Reference: 510(k) submission, Section Labeled PerformanceTesting - Bench
	The hematocrit sensitivity of the Contour NEXT EZ System wasevaluated with fresh venous blood samples ranging from 15% to65% hematocrit. The plasma glucose concentrations were adjusted to40 mg/dL and 550 mg/dL glucose. Twelve replicates per samplewere collected on six Contour NEXT meters for each of the three lotsof sensors. The results indicate that the assay bias is within 10mg/dL(when sample glucose values <100mg/dL) or 10% (when sampleglucose values ≥100mg/dL) when compared to YSI references or to40% Hct whole blood samples.
	The results indicate that there is no trend of increasing assay.
	imprecision or bias by increasing sample hematocrit.
	Other potential interference substances were tested: Acetaminophen,Ascorbic Acid, Bilirubin, Cholesterol, Creatinine HCl, DopamineHCl, Galactose, Na Gentisate, Glutathione, Hemoglobin (g/dL),Ibuprofen (Na salt), L-Dopa, Maltose, Methyl Dopa, Na Salicylate,Tolazamide, Tolbutamide, Triglycerides, Uric Acid, XyloseIcodextrin, Caffeine, Ephedrine, and Tetracycline.
	It is shown that in the above substances, only xylose has a significanteffect over the range tested. Therefore, in the instruction for use, itindicates “Do not use during or soon after xylose absorption testing.Xylose in the blood will cause an interference.”
Assay cut-off	Not applicable

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SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Clinical study	Reference: 510(k) submission, Section -001_004 Clinical TrialsBook Additional Information 2)
	Protocol: A clinical study was conducted at a clinical site with 115subjects. Three lots of test strips were randomly assigned to thesubjects. The clinical performance of the Contour NEXT EZ Systemhas been demonstrated by comparing the results from the YSI labanalyzer and the HCP/User test results on the same fresh finger tipcapillary blood sample.
	Criteria: ISO 15197:2003 Section 8 does not establish the clinicaltrials acceptance criteria. The internal acceptance criteria are thatninety-five percent (95%) of the individual glucose results shall fallwithin $\pm$ 15 mg/dL of the results of the manufacturer's measurementprocedure at glucose concentrations < 75 mg/dL and within $\pm$ 20 %at glucose concentrations ≥ 75 mg/dL.
	Results: All (100%) Contour NEXT results meet the above accuracyrequirements. Moreover, Contour NEXT results show that 100% ofresults fall within $\pm$ 10 mg/dL at <75 mg/dL and 96.3% fall within$\pm$ 10% at ≥ 75 mg/dL when tested by users on the same freshfingertip capillary blood sample, as shown in the following table.

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Results within:	±5mg/dL	±10mg/dL	±15mg/dL
YSI Glucose <75 mg/dL	6 of 7(85.7%)	7 of 7(100.0%)	7 of 7(100.0%)
Results within:	±5%	±10%	±15%	±20%
YSI Glucose ≥75 mg/dL	83 of 108(76.9%)	104 of108(96.3%)	107 of108(99.1%)	108 of 108(100.0%)
Combinedresults within:	±5mg/dL or5%	±10mg/dL or10%	±15mg/dL or15%	±15 mg/dLor 20%
Total	89 of 115(77.4%)	111/115(96.5%)	114 of115(99.1%)	115 of 115(100.0%)

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The performance of the Contour NEXT EZ Blood Glucose Monitoring System is substantially equivalent to the performance of the previously cleared Contour Blood Glucose Monitoring System (K062058).

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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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized image of an eagle or other bird with its wings spread. The bird is drawn with thick, black lines and has a modern, abstract design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Bayer Health Care LLC, Diabetes Care c/o Weiping Zhong Regulatory Affairs Specialist 430 South Beiger Street Mishawaka, IN 46544, USA

10903 New Hampshire Avenue Silver Spring, MD 20993

MAR - 6 2012

Re: K111268

Contour NEXT EZ Blood Glucose Monitoring System Trade/Device Name: Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: February 24, 2012 Received: February 27, 2012

Dear Sir/Madam:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w o no re reviews of 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 do not require approvisions 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 I least of 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket r mis four will anony you to of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific ad 1700 - 10 yourse Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 production total regulations regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of Darremance and sale of 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 I ou may 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 vours,

signature

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 (if known): K111268

Device Name: Contour NEXT EZ Blood Glucose Monitoring System

Indications For Use:

Intended Use

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.

x Prescription Use And/Or (21 CFR Part 801 Subpart D)

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)

Sutto chine

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

KIII268 510(k)

Page 1 of 1

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.