FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001

K051839 · Abbott Diabetes Care, Inc. · NBW · Mar 9, 2006 · Clinical Chemistry

Device Facts

• Record ID: K051839
• Device Name: FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FreeStyle Freedom™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand. The FreeStyle Freedom™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

Device Story

FreeStyle Freedom BGMS measures glucose in whole blood samples using coulometric biosensor technology. Device utilizes test strips containing glucose dehydrogenase (GDH) enzyme to recognize glucose; electrochemical measurement occurs via biosensor. System provides quantitative glucose concentration readings. Used by healthcare professionals and patients at home for diabetes management. Features include 4 programmable alarms and LCD display. Output allows patients/providers to monitor diabetes control program effectiveness. Differences from predicate include modified LCD size, addition of alarm modes, factory-set measurement units, and reduced assay time (average 5 seconds).

Clinical Evidence

Performance evaluated via laboratory studies and clinical accuracy studies with lay users. Clinical data demonstrates that lay users obtain results correlating well with laboratory reference glucose values. No specific sensitivity/specificity metrics provided in summary.

Technological Characteristics

Coulometric electrochemical biosensor. PQQ-dependent glucose dehydrogenase enzyme. Operating range: 5-40°C, 5-90% humidity, 15-65% hematocrit. Concentration range: 20-500 mg/dL. Sample size: 0.3 uL. Connectivity: PC download via interface cable. Calibration: Lot-specific code entry. Software: Internal algorithm for charge-to-concentration conversion based on temperature and enzyme activity.

Indications for Use

Indicated for quantitative blood glucose measurement in people with diabetes mellitus (home use) and healthcare professionals. Sites: finger, forearm, upper arm, thigh, calf, hand. Contraindications: neonates, arterial blood, diagnosis or screening of diabetes.

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 Blood Glucose Monitoring System (K992684, K000582, K012014, K031260, K050500)

Submission Summary (Full Text)

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#### 2006 MAR 9

## 510(k) Summary

This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. The assigned 510(k) number is K051839.

| Company | Abbott Diabetes Care Inc. |
|------------------------|-------------------------------------------------------|
| Street Address | 1360 South Loop Road |
| City, State Zip | Alameda, CA 94502 |
| Phone | 510-749-6475 |
| Contact Person: | Dhruma Shah<br>[e-mail] |
| Proprietary Name: | FreeStyle Freedom™ Blood Glucose Monitoring<br>System |
| Common Name: | Blood Glucose Testing System |
| Classification Number: | 21 CFR §862.1345 |
| Predicate Device: | FreeStyle Blood Glucose Monitoring System |
| Date Prepared: | July 1, 2005 |

#### Description of the Device:

The FreeStyle Freedom™ monitor utilizes coulometric biosensor technology found in the FreeStyle Freedom test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Freedom BGMS measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip.

#### Intended Use of the Device:

The FreeStyle Freedom Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

The FreeStyle Freedom Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

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#### Comparison to Predicate Device:

| | Predicate Device | Subject (modified) Device |
|------------------------|-------------------------------------------------------------|--------------------------------------------------------|
| Company | Abbott Diabetes Care Inc | Same |
| 510(k) Reference | K992684, K000582, K012014,<br>K031260, K050500 | Current Submission |
| Proprietary Name: | FreeStyle Blood Glucose<br>Monitoring System | FreeStyle FreedomTM Blood<br>Glucose Monitoring System |
| Common Name: | Blood Glucose Testing System | Same |
| Classification Number: | 21 CFR §862.1345 | Same |
| Intended Use | Quantitative measurement of<br>blood glucose concentrations | Same |
| Single Use? | No | Same |
| Sterilized? | No | Same |

### Differences from Predicate Device

| Modification<br>Description | FreeStyle | FreeStyle<br>Freedom |
|------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------|
| LCD size change | 30.5 mm Width<br>27.5 mm Height | 28.5 mm Width<br>34.5 mm Height |
| Alarm mode | Not included | 4 programmable alarm<br>settings |
| Lock unit of<br>measure for<br>Glucose reading | User selectable unit<br>of measure (mg/dL<br>or mmol/L) | Unit of measure set to<br>either mg/dL or mmol/L<br>at manufacturer |
| Glucose<br>Measurement<br>Assay Time | Average 7 seconds | Average 5 seconds |

#### Performance Studies:

The performance of the FreeStyle Freedom Blood Glucose Monitoring System was evaluated in laboratory studies as well as accuracy and lay user clinical studies. Data from the clinical studies demonstrates that lay users can obtain results from the FreeStyle Freedom Blood Glucose Monitoring System that correlate well with the laboratory reference glucose values.

#### Conclusion:

Results of laboratory and clinical testing demonstrate that the performance of the FreeStyle Freedom™ Blood Glucose Monitoring System is substantially equivalent to the performance of the predicate devices for blood glucose testing and suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

MAR 9

2006

Dhruma Shah Regulatory Affairs Associate Abbott Laboratories/TheraSense Inc. Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502

Re: k051839

Trade/Device Name: FreeStyle Freedom™ Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR Dated: January 20, 2006 Received: January 23, 2006

Dear Ms. Shah:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 --

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

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

Enclosure

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# Indications for Use Statement

510(k) Number : K051839

Device Name: FreeStyle Freedom™ Blood Glucose Monitoring System

Indications for Use:

The FreeStyle Freedom™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

The FreeStyle Freedom™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use V (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Alberto S
Division Sign-Off

Office of In Vitro Diagn Device Evaluation and

510(k) K051839