FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM

K120568 · Abbott Diabetes Care, Inc. · NBW · Mar 29, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120568
• Device Name: FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 29, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

Device Story

System uses coulometric biosensor technology to measure glucose in capillary whole blood. Meter reacts glucose with Glucose Dehydrogenase (GDH) on test strip; electrochemical mediation generates electrical current proportional to glucose concentration. Device features touch screen, automated logbook, and 'plug and play' software for PC-based reporting. Patients/HCPs set reminders and target ranges. Software generates reports (Snapshot, Modal Day, Logbook, Statistics, Meal Averages) to facilitate therapy management. Used by patients at home for self-monitoring; data reviewed by HCPs to assess diabetes control. Modification adds lancing device and lancets to kit.

Clinical Evidence

No clinical data presented. Substantial equivalence established via bench testing and comparison of technical specifications to the predicate device.

Technological Characteristics

Coulometric biosensor; GDH-FAD enzyme; 0.3 µL sample volume; 5-second measurement time; 20-500 mg/dL range; 15-65% hematocrit range. Connectivity via USB. No coding required. Software resides on meter.

Indications for Use

Indicated for single-patient use for blood glucose monitoring.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• FreeStyle InsuLinx Blood Glucose Monitoring System (k111874)

Submission Summary (Full Text)

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MAR 2 9 2012

120568

## 510(k) Summary

According to the requirements of 21 CFR §807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

| Company: | Abbott Laboratories |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Division: | Abbott Diabetes Care, Inc. |
| Street Address: | 1360 South Loop Road |
| City, State Zip: | Alameda, CA 94502 |
| Telephone No: | 510-749-5400 |
| Fax No: | 510-864-4791 |
| Contact Person: | Arul Sterlin;<br>Tel No. 510-864-4310;<br>Fax No. 510-864-4791;<br>[e-mail] |
| Proprietary Name: | FreeStyle InsuLinx Blood Glucose Monitoring System |
| Common Name: | Glucose Test System |
| Classification Name: | System, test, blood glucose, over the counter, Glucose, Class II (21 CFR§ 862.1345)<br>Product codes: NBW;<br>Glucose Dehydrogenase, Glucose, Class II (21 CFR§ 862.1345)<br>Product codes: LFR; |
| Predicate Device: | FreeStyle InsuLinx Blood Glucose Monitoring System (k111874) |
| Legal Manufacturer: | Establishment:<br>Abbott Diabetes Care Inc.<br>1360 South Loop Rd.<br>Alameda, CA 94502<br>Registration Number: 2954323 |

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#### Indications For Use:

The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.

The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

#### Description of the Device:

The FreeStyle InsuLinx Meter, in conjunction with the FreeStyle InsuLinx Test Strips works on the principal of coulometric biosensor technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrochemical mediation.

The device automatically logs blood glucose results and other events to create a customized logbook. The FreeStyle InsuLinx System has a large touch screen and a user interface designed for an easy user experience.

Patient and Healthcare Professionals can pre-program audible and visual reminders for blood glucose testing, or other individual needs.

Weekly messages feature assist the patient in identifying patterns in their blood glucose results. Using a rolling report, the measured glucose values are summarized according to the proportion within, above. or below the predetermined target range entered by the patient or HCP. These

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results are displayed in a simple graphical format and include a count of the tests performed. An additional algorithm compares the prevailing blood glucose levels during the preceding week with simple messages relating to achievement versus target glucose levels.

The FreeStyle InsuLinx System has 'plug and play' software that automatically installs on a computer without the need for a CD or internet access (via the meter's USB port and a provided cable). It also provides access to the structured reports for both the healthcare professionals and patients.

The FreeStyle Auto-Assist software produces six different reports to facilitate discussion between patients and their health care professionals in the review, and evaluation of historical blood glucose test results to support an effective diabetes management program. The software also shows trends in blood glucose data in both graphical and text format for guided interpretation.

The Snapshot Report is a general summary of the data for a specified date range.

The Modal Day Report shows the daily patterns of blood glucose levels over a specified date range

The Logbook Report is a table of blood glucose for each day in the specified date range.

The Daily Statistics Report provides an overview of blood glucose over the date range in a series of charts and tables.

The Meal Event Averages Report compares the before and after meal blood glucose level averages for the morning, mid-day and evening times over the specified date range.

The Meter Settings Report shows current meter settings.

These reports provide detailed information on glucose monitoring, and are designed to enable healthcare professionals and patients to assess the effectiveness of diabetes management and then plan appropriate changes to therapy regimens.

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#### Principles of Operation:

The FreeStyle InsuLinx Meter (in conjunction with FreeStyle InsuLinx blood glucose test strips) utilizes coulometric biosensor technology to quantitatively measure the glucose concentration in whole blood samples and in FreeStyle Control Solutions.

The FreeStyle InsuLinx Meter measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood or control solutions by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip. The electrons liberated by this reaction are transferred via a co-factor and mediator to the meter where they are read as a small electrical current is integrated over the analysis time to generate charge which is directly proportional to the level of the glucose in the applied sample.

The FreeStyle InsuLinx Meter does not require calibration prior to use with the FreeStyle InsuLinx Test Strips. The device is prepared for use by inserting a FreeStyle InsuLinx test strip in the test strip port. Upon strip insertion, the meter will turn on automatically and perform a display check. The 'apply blood' message is displayed for the user to apply blood to the test strip until the meter begins the test. Blood detect will occur when the meter detects trigger current from the test strip, when enough blood has covered the strip electrodes. Following the blood detect, the meter performs the glucose assay measurement.

#### Description of Modification:

The basis for this submission, is to include the FreeStyle Lancing Device and Lancets in the FreeStyle InsuLinx System Kit, which is packaged with the following components and accessories listed below.

(A) FreeStyle InsuLinx Meter

- (B) 10 count vial of FreeStyle InsuLinx Test Strips (may be sold separately)
- (C) FreeStyle Auto-Assist software (resides in the FreeStyle InsuLinx Meter)

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- (D) Carrying Case
- (E) Owner's Booklet
- (F) Quick Start Guide
- (G) USB Cable
- (H) FreeStyle Control Solutions (mạy be obtained by contacting Customer Service)

### Comparison to Predicate Device:

The similarities between the modified FreeStyle InsuLinx System and the predicate are highlighted below:

| PRODUCT NAME | FreeStyle InsuLinx Blood Glucose Monitoring System (k111874) | Modified FreeStyle InsuLinx Blood Glucose Monitoring System |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| CHARACTERISTICS | | |
| Indications for Use | The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FreeStyle InsuLinx Blood Glucose Monitoring System | Same |

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| PRODUCT NAME | FreeStyle InsuLinx Blood<br>Glucose Monitoring System<br>(k111874) | Modified FreeStyle InsuLinx<br>Blood Glucose Monitoring<br>System | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|
| | should not be used for the<br>diagnosis of or screening for<br>diabetes or for neonatal use.<br><br>The FreeStyle InsuLinx Blood<br>Glucose Test Strips are for<br>use with the FreeStyle<br>InsuLinx Blood Glucose<br>Meter to quantitatively<br>measure glucose in capillary<br>whole blood samples drawn<br>from the fingertip. | | |
| Classification Product<br>Code | NBW, LFR | Same | |
| Fundamental<br>Technology | The FreeStyle InsuLinx Meter<br>(in conjunction with blood<br>glucose test strips) utilizes<br>coulometric biosensor<br>technology to quantitatively<br>measure the glucose<br>concentration in whole blood<br>samples and in FreeStyle<br>Control Solutions | Same | |
| Enzyme | GDH - FAD | Same | |
| Sample Type | Whole blood & capillary | Same | |
| Test Sites | Finger | Same | |
| Sample Volume | 0.3 µL | Same | |
| Measurement Glucose<br>Range | 20 to 500 mg/dL | Same | |
| Meter Operating<br>Humidity | 5 to 90% Relative Humidity,<br>Non-Condensing | Same | |
| Storage Operating<br>Temperature | -4°F to 140°F (-20°C to<br>+60°C) | Same | |
| Precision | At glucose levels below<br>75mg/dL average SD is ≤<br>5mg/dL and at glucose levels<br>≥ 75mg/dL average CV is ≤<br>5% | Same | |
| Accuracy | 95% of results should fall<br>within ± 15mg/dL of the<br>comparative method results at<br>glucose concentrations < | Same | |
| PRODUCT NAME | FreeStyle InsuLinx Blood<br>Glucose Monitoring System<br>(k111874) | Modified FreeStyle InsuLinx<br>Blood Glucose Monitoring<br>System | |
| | 75mg/dL and within ±20% at<br>glucose concentrations ≥ 75<br>mg/dL | | |
| Measurement Module | FreeStyle Super Speedy<br>Algorithm (5 seconds) | Same | |
| Double Application | 60 seconds | Same | |
| Meter Operating<br>Temperature | 40°F to 104°F (4°C to 40°C) | Same | |
| Meter Operating<br>Pressure | Up to 10000 feet (3048<br>meters) | Same | |
| Hematocrit | 15% - 65% | Same | |
| Data Management | FreeStyle Auto-Assist<br>software | Same | |
| Application Software | Software running on the meter<br>provides the User with an<br>Electronic Logbook, Data<br>Management and Diabetes<br>Management Tools | Same | |
| Measurement Time | average 5 seconds | Same | |
| Coding | No coding required | Same | |
| Microprocessor | ST | Same | |
| User Preferences | The device lets the user set:<br>• Time and Date Changes<br>• Time and Date Formats<br>• Audible Alert<br>• Personalized test screen<br>• Weekly Message glucose<br>ranges<br>• Personalized notes and<br>reminders | Same | |
| Summary Statistic<br>Elements | • Snapshot Report<br>• Modal Day Report<br>• Logbook Report<br>• Daily Statistics Report<br>• Meal Event Averages<br>Report<br>• Meter Settings Report<br>• Weekly messages | Same | |
| | PRODUCT NAME | FreeStyle InsuLinx Blood<br>Glucose Monitoring System<br>(k111874) | Modified FreeStyle InsuLinx<br>Blood Glucose Monitoring<br>System |
| | | screen that enables<br>configuration of the device<br>through the PC | |

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The differences between the modified FreeStyle InsuLinx System and the predicate are highlighted below:

| PRODUCT NAME | FreeStyle InsuLinx Blood<br>Glucose Monitoring System<br>(k111874) | Modified FreeStyle InsuLinx<br>Blood Glucose Monitoring<br>System |
|-----------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| CHARACTERISTICS | | |
| Accessories | (A) FreeStyle InsuLinx<br>Meter | (A) Same |
| | (B) 10 count vial of<br>FreeStyle InsuLinx Test Strips<br>(may be sold separately) | (B) Same |
| | (C) FreeStyle Auto-Assist<br>software (resides in the<br>FreeStyle InsuLinx Meter) | (C) Same |
| | (D) Carrying Case | (D) Same |
| | (E) Owner's Booklet | (E) Same |
| | (F) Quick Start Guide | (F) Same |
| | (G) USB Cable | (G) Same |
| | (H) FreeStyle Control<br>Solutions (may be obtained by<br>contacting Customer Service) | (H) Same |
| | | (I) FreeStyle Lancing Device |
| | | (J) FreeStyle Lancets |

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10903 New Hampshire Avenue Silver Spring, MD 20993

Abbott Diabetes Care Inc. c/o Arul Sterlin 1360 South Loop Rd. Alameda, California 94502

MAR 2 9 2012

Re: k120568

Trade Name: FreeStyle InsuLinx Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR Dated: February 24, 2012 Received: February 29, 2012

Dear Mr. Sterlin:

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 [phone]. 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

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): ____________________________________________________________________________________________________________________________________________________

Device Name: FreeStyle InsuLinx Blood Glucose Monitoring System

Indications For Use:

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The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood The I recorre Insultin Drood Criese glucose in capillary whole blood samples drawn from the fingertip.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

And/Or

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

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

510(k) K120568