FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM

K070850 · Abbott Diabetes Care, Inc. · NBW · Apr 10, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070850
• Device Name: FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FreeStyle Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand. The FreeStyle Lite 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 Lite Blood Glucose Monitoring System (BGMS) uses coulometric biosensor technology to measure glucose concentration in whole blood. Device employs glucose dehydrogenase (GDH) enzyme on test strips to recognize glucose; electrochemical measurement occurs via coulometry. System designed for use by healthcare professionals and patients at home to monitor diabetes control programs. Input is whole blood sample (0.3 microliter); output is quantitative glucose concentration (mg/dL) displayed on monitor. Key features include 400-result memory and 7-, 14-, and 30-day averages. Device eliminates manual calibration code entry required by predicate. Powered by 3V coin cell battery; includes serial port for communication. Provides patients with actionable data for diabetes management.

Clinical Evidence

Bench testing only; design control activities and verification/validation testing performed to confirm that modifications met predetermined acceptance criteria; no clinical data provided.

Technological Characteristics

Electrochemical glucose monitoring system; features backlight and test light; includes 7 and 30-day moving average calculation capability; increased data storage; no-code calibration; fundamental sensing technology consistent with predicate.

Indications for Use

Indicated for quantitative glucose measurement in whole blood for patients with diabetes mellitus. Suitable for use by healthcare professionals and patients at home. Sites include finger, forearm, upper arm, thigh, calf, and hand. Contraindicated for neonates and arterial blood samples.

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 Freedom™ Blood Glucose Monitoring System (K051839)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" on the left, followed by the words "Abbott" and "Diabetes Care" stacked on top of each other. The text is in a bold, sans-serif font.

Abbott Diabetes Care Inc 1360 South Loop Road Alameda, CA 94502

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LO70850

APR 1 0 2007

# 510(k) Summary

Per 21 CFR §807.92

| Date Prepared: | March 27, 2007 | |
|----------------------|---------------------------------------------------------------------------------------|--|
| 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: | Dhruma Shah<br>Tel No. 510-749-6475<br>Fax No. 510-864-4791<br>[e-mail] | |
| Proprietary Name: | FreeStyle™ Lite Blood Glucose Monitoring System | |
| Common Name: | Blood Glucose Testing System, Glucose<br>Dehydrogenase | |
| Classification Name: | Glucose Test System (21 CFR §862.1345, Product<br>code NBW, LFR) | |
| Predicate Device: | FreeStyle Freedom™ Blood Glucose Monitoring<br>System (K051839) | |

# Description of the Device:

The FreeStyle™ Lite Blood Glucose Monitoring System (BGMS) utilizes coulometric biosensor technology found in the FreeStyle Lite test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Lite 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 Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

The FreeStyle Lite Blood Glucose Monitoring System is intended for use in the

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Image /page/1/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of two parts: a stylized letter 'A' on the left and the text 'Abbott Diabetes Care' on the right. The text is in a bold, sans-serif font, with 'Abbott' on the top line and 'Diabetes Care' on the bottom line.

Abbott Diabetes Care Inc 1360 South Loop Road Alameda, CA 94502

t [phone] f [phone]

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.

| | Predicate Device<br>(K051839) | Subject (modified)<br>Device |
|--------------------------------|----------------------------------------|----------------------------------------------|
| Enzyme | PQQ dependent glucose<br>dehydrogenase | Same |
| Reagent Form | Test Strip | Same |
| Analyte | D-Glucose | Same |
| Detection Method | Electrochemical-(Coulometric) | Same |
| Recommended<br>Sample | Venous or capillary whole<br>blood | Same |
| Calibration | Manual calibration code entry | No manual calibration code<br>entry required |
| Minimum Sample<br>Size | 0.3 microliter (300 nanoliter) | Same |
| Measurement Range | 20-500 mg/dL | Same |
| Measurement Time | 5 seconds (average) | Same |
| Hematocrit Range | 15% to 65% | Same |
| Humidity Range | 5% to 90% | Same |
| Operating<br>Temperature Range | 40°-104° F | Same |
| Monitor Memory | 250 test results | 400 test results |
| Day averages | 14-day average | 7-, 14- & 30-day averages |
| Date/Time | Yes | Same |
| Communication | Serial Port | Same |
| Power Source | 3V Coin Cell Battery | Same |

## Comparison to Predicate Device:

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Image /page/2/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of the Abbott "A" symbol on the left, followed by the text "Abbott" on the top line and "Diabetes Care" on the bottom line. The text is in a sans-serif font and is black.

Abbott Diabetes Care Inc 1360 South Loop Road Alameda, CA 94502

t [phone] f [phone]

#### Assessment of Non-Clinical Performance Data:

The performance of the FreeStyle Lite Blood Glucose Monitoring System was studied in The results obtained during these studies demonstrated that the the laboratory. FreeStyle Lite Blood Glucose Monitoring System is substantially equivalent to the predicate device.

#### Conclusion:

Results of laboratory testing demonstrated that the performance of the FreeStyle™ Lite Blood Glucose Monitoring System is acceptable and comparable in terms of safety and effectiveness to the performance of the predicate device for blood glucose testing when used according to its intended use.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 0 2007

Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502-7000 ATTN: Dhruma Shah

Re: k070850

> Trade/Device Name: FreeStyle™ Lite Blood Glucose Monitoring System Regulation Number: 21 CFR \$862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 28, 2007 Received: March 29, 2007

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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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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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 : (if known)

K070850

#### FreeStyle™ Lite Blood Glucose Monitoring System Device Name:

Indications for Use:

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

The FreeStyle™ Lite 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 X (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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