K Number
K110587
Device Name
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
Date Cleared
2012-03-28

(393 days)

Product Code
Regulation Number
862.1345
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CONTOUR® LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip only. CONTOUR® test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps through use of radio frequency communication. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
Device 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)
More Information

Not Found

No
The document describes a standard blood glucose monitoring system that measures glucose levels and transmits the data. There is no mention of AI or ML in the intended use, device description, or performance studies. The studies focus on analytical accuracy and user performance, not on algorithmic learning or prediction.

No
The device is a diagnostic tool for measuring blood glucose, not a therapeutic device that directly treats a condition.

No

The "Intended Use / Indications for Use" section explicitly states, "The CONTOUR® LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus." It is used for measurement of glucose in whole blood for persons with diabetes, which is for monitoring, not diagnosis.

No

The device description explicitly states that the system features a "CONTOUR LINK Wireless Blood Glucose Monitor" and "CONTOUR Blood Glucose Test Strips," which are hardware components. The software is part of a larger system that includes physical hardware for measuring glucose.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The primary intended use is "for the measurement of glucose in whole blood". This is a diagnostic measurement performed in vitro (outside the body) on a biological sample (whole blood).
  • Sample Type: It uses "fresh capillary whole blood samples drawn from the fingertip". This is a biological specimen.
  • Measurement: It performs a "quantitative measurement of glucose". This is a diagnostic test.
  • Device Description: It is a "Blood Glucose Monitoring System" which includes a meter and test strips, components specifically designed for in vitro diagnostic testing of blood glucose.

While it's not intended for diagnosis or screening of diabetes, the act of measuring glucose in a blood sample for monitoring purposes in individuals with diabetes falls squarely under the definition of an In Vitro Diagnostic device. The fact that it transmits data to an insulin pump doesn't change its fundamental function as a blood glucose measurement device.

N/A

Intended Use / Indications for Use

The CONTOUR® LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip only. CONTOUR® test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.
The CONTOUR® LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps through use of radio frequency communication.
The CONTOUR® LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Product codes (comma separated list FDA assigned to the subject device)

LFR, NBW

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)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertip

Indicated Patient Age Range

Not intended for use on neonates.

Intended User / Care Setting

persons with diabetes in home settings

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Precision
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).
Intermediate Precision
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.
Accuracy
Protocol: Fresh capillary blood was collected in the glucose range distribution specified by ISO 15197 Section 7.3. One hundred blood samples were tested using each of two CONTOUR test strip lots on two CONTOUR LINK meters for a total of 400 readings. Samples were also tested in parallel on a YSI 2300 STAT PLUS glucose analyzer.
Linearity/assay reportable range
Two studies were conducted to establish the linearity of the CONTOUR system throughout the entire reportable range of 10 to 600 mg/dL. In one study, blood with a hematocrit level of 40% was adjusted to plasma glucose concentrations of 20, 30, 40, 50, and 60 mg/dL and tested with three CONTOUR lots, 24 sensors per lot.
Eight meters were used, with three sensors per lot tested on each.
Detection limit
The low glucose concentration testing conducted as part of the Linearity/Assay Reportable Range above confirmed detection limit. In addition, three production lots of CONTOUR sensors were tested with whole blood samples manipulated to have glucose concentrations of 5, 900, 1200, 1500 and 1800 mg/dL, 24 sensors per samples.
Method comparison with predicate device (K062058)
Protocol: The CONTOUR and CONTOUR LINK meters were tested in a comprehensive fingerstick study using fresh capillary blood samples. In this study, the RF function of the CONTOUR LINK was left on to simulate real-world usage.
Materials and Method: Samples from 111 subjects were collected by fingerstick and tested using two lots of CONTOUR sensors. Four CONTOUR meters were used, with disinfection between each subject. Plasma samples were tested in duplicate on the YSI reference method, with the average value used for the comparison. Hematocrit values also were measured. All measurements were performed at 23°C + 5°C. In most cases, samples were tested fresh from the finger without any modification. However, samples at very low and very high glucose concentrations were created by either glycolyzing a specimen to lower the glucose concentration or supplementing a specimen with a concentrated glucose solution to increase the glucose level.
Clinical study (subject device)
Protocol: The subject pool included 77 adults aged 20 through 85, for use for self-testing, and the resulting accuracy of results, were assessed.
Clinical study (predicate device 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision
Study Type: Repeatability
Sample Size: 100 (10 meters, 10 replicates each)
Key Results: Cpk values are greater than 1.0 when compared to established accuracy requirements of ± 20% or ± 15mg/dL. Mean, SD and %CV results were provided.
Intermediate Precision
Study Type: Intermediate Precision
Sample Size: Not explicitly stated, but involved 10 meters over 10 days with three control levels.
Key Results: Cp values are over 1.0 when compared to established limits of + 11% or + 5mg/dL. Mean, SD and %CV results were provided for each control level.
Accuracy
Study Type: System Accuracy Evaluation
Sample Size: 400 readings (100 blood samples, 2 test strip lots, 2 meters)
Key Results: 98.7 % of the individual glucose results fell within ± 15 mg/dL of the results obtained on the YSI analyzer at glucose concentrations 75 mg/dL). All control solution test performed by subjects (77) generated in-range glucose values, and all were marked as controls by the meters.
Clinical study (predicate device K062058)
Study Type: Clinical Accuracy (self-testing)
Sample Size: 109 adults
Key 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy:
98.7 % of the individual glucose results fell within ± 15 mg/dL of the results obtained on the YSI analyzer at glucose concentrations 75 mg/dL).
Clinical Study (Predicate Device):
More than 96% were within the limits of ±15 mg/dL or ±20% of the laboratory glucose method.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

CONTOUR Blood Glucose Meter (K062058), OneTouch UltraLink Blood Glucose Meter (K073231)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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
NameBayer Healthcare
Address555 White Plains Road
Tarrytown, NY 10591
Phone number(914) 366-1800
Fax number(914) 366-1899
Establishment
Registration
Number3003962513
Name of contact
personChuck Ryan
Date preparedMarch 27, 2012
Name of device
Trade or proprietary
nameCONTOUR® LINK
Common or usual
nameWireless Blood Glucose Monitoring System
Classification nameGlucose Test System
Classification panelClinical Chemistry and Clinical Toxicology
Regulation21 CFR 862.1345
Product Code(s)LFR (Glucose Dehydrogenase, Glucose), NBW (System, Test, Blood Glucose, Over The Counter)
Legally marketed
device(s) to which
equivalence is claimedCONTOUR Blood Glucose Meter (K062058)
OneTouch UltraLink Blood Glucose Meter (K073231)
Reason for 510(k)
submissionAddition of RF wireless transmission capability
Device descriptionThe 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)
Intended use of the deviceSee Indications for Use below
Indications for useThe 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.
Summary of the Technological Characteristics of the New Device Compared to
Predicate 1
SIMILARITIES to Predicate 1
CharacteristicNew Device
Bayer's CONTOUR LINK
meterPredicate 1
Bayer's CONTOUR meter
K062058
Detection
TechnologyAmperometric measurement of
blood glucosesame
Reference methodPlasma equivalentsame
Test stripCONTOUR test stripsame
Test Strip enzymeGlucose Dehydrogenase FADsame
Calibration/CodingNo coding neededsame
AccuracyMeets ISO 15197 requirementssame
Reaction time5 secondssame
DIFFERENCES from Predicate 1
RF
Communication
ProtocolTransmits glucose values to
compatible MiniMed Paradigm
and Guardian REAL Time
devices.No RF capability
Alternative site
testingFingertip onlyFingertip, palm or forearm
Measurement
range20-600 mg/dL10-600 mg/dL
Sample typeCapillary whole blood samples
only. Not for use on neonates.Capillary, venous, and
arterial whole blood
samples and neonatal blood
samples
Hct range20-65%0-70%
Summary of the Technological Characteristics of the New Device Compared to Predicate 2
SIMILARITIES to Predicate 2
CharacteristicNew Device
Bayer's CONTOUR LINK
meterPredicate 2
LifeScan OneTouch
UltraLink meter
K073231
Detection
TechnologyAmperometric measurement of
blood glucosesame
Reference methodPlasma equivalentsame
AccuracyMeets ISO 15197 requirementssame
Sample typeCapillary whole blood samples only. Not for use on neonates.same
Reaction time5 secondssame
Measurement range20-600 mg/dLsame
RF Communication ProtocolTransmits glucose values to compatible Medtronic MiniMed devices.same
DIFFERENCES from Predicate 2
Test StripCONTOUR test stripOneTouch Ultra test strip
Test Strip enzymeGlucose Dehydrogenase FADGlucose Oxidase
Alternative site testingFingertip onlyFingertip, palm or forearm
Calibration/CodingNo coding neededManual coding required
Hct range20-65%30-55%
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR
DETERMINATION OF SUBSTANTIAL EQUIVALENCE

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Performance Test Summary-New Device

Characteristic

Results Summary

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PrecisionRepeatability (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/dLSD,mg/dLCV%
41.81.26
78.11.993.02%
125.72.55%
198.02.672.12%
312.34.322.18%
5.011.60%
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:
ControlMean,SD,mg/dLCV%
Levelmg/dL
Low38.90.551.41
Normal121.71.261.04
High354.94.491.26

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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 glucose
range distribution specified by ISO 15197 Section 7.3. One
hundred blood samples were tested using each of two CONTOUR
test strip lots on two CONTOUR LINK meters for a total of 400
readings. Samples were also tested in parallel on a YSI 2300
STAT PLUS glucose analyzer. | | | |
| | Acceptance Criteria: A minimum of 95 % of the individual
glucose results shall fall within ± 15 mg/dL of the results
obtained on the YSI analyzer at glucose concentrations 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 | >200
mg/dL | ≤7% | Passed |
| | Galactose | >200
mg/dL | ≤7% | Passed |
| | Xylose | Interferes with test | | |
| Assay cut-off | Not applicable | | | |
| COMPARATIVE PERFORMANCE INFORMATION SUMMARY | | | | |
| Method
comparison with
predicate device
(K062058) | Reference: 510(k) submission, Section 018-3
Protocol: The CONTOUR and CONTOUR LINK meters were
tested in a comprehensive fingerstick study using fresh capillary
blood samples. In this study, the RF function of the CONTOUR
LINK was left on to simulate real-world usage.
Materials and Method
Samples from 111 subjects were collected by fingerstick and
tested using two lots of CONTOUR sensors. Four CONTOUR
meters were used, with disinfection between each subject.
Plasma samples were tested in duplicate on the YSI reference
method, with the average value used for the comparison.
Hematocrit values also were measured. All measurements were
performed at 23°C + 5°C.
In most cases, samples were tested fresh from the finger without
any modification. However, samples at very low and very high
glucose concentrations were created by either glycolyzing a
specimen to lower the glucose concentration or supplementing a
specimen with a concentrated glucose solution to increase the
glucose 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 1.008
Intercept: 0.49, confidence interval = -0.4 to 1.38 mg/dL

Reference: 510(k) submission, Section 018-2

Protocol: 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 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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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

12

Indications for Use

510(k) Number K110587:

Device Name: CONTOUR® LINK Wireless Blood Glucose Monitoring System

Indications for Use:

The CONTOUR® LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip only.

CONTOUR® test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The CONTOUR® LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps through use of radio frequency communication.

The CONTOUR® LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

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