FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM

K050500 · Abbott Diabetes Care, Inc. · NBW · Jun 27, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050500
• Device Name: FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FreeStyle 600 Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle 600 Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle 600 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

Device Story

System comprises handheld meter, electrochemical biosensor test strips, quality control solution, and lancing device. User inserts test strip into meter; applies blood sample (capillary, venous, arterial, or neonatal) to strip target area via capillary action. Meter detects sample, emits audible tone, and performs electrochemical reaction using glucose dehydrogenase enzyme. Meter measures resulting electrical current, calculates glucose concentration, and displays result on LCD. Used in home and professional settings by patients or healthcare providers. Provides quantitative glucose readings to assist in blood glucose monitoring and clinical decision-making.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by healthcare professionals. Studies demonstrated that healthcare professionals obtained blood glucose results substantially equivalent to a comparative method.

Technological Characteristics

Electrochemical biosensor; glucose dehydrogenase enzyme reagent; capillary action sample intake; 0.3 microliter sample volume; LCD display; handheld form factor.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary, venous, arterial, and neonatal whole blood samples for home and professional use.

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)

Submission Summary (Full Text)

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## JUN 27 2005

## 510(k) SUMMARY

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This summary of 510(k) Safety and Effectiveness information is being submitted in This sunning of I 10(x) Satsy and Enectrical so the Manch 2008 and 2008 and 2008 and 2008
accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k

| Date Prepared: | February 23, 2005 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Kimberley Kline<br>Senior Regulatory Associate |
| | TheraSense, Inc.<br>1360 South Loop Road<br>Alameda, CA 94502 |
| | Phone: [phone]<br>Fax: [phone] |
| Device Name: | FreeStyle 600 Blood Glucose Monitoring System |
| Common Name: | Blood Glucose Meter and Reagent Test Strips |
| Classification: | Glucose Test System<br>Class II per 21 CFR 862.1345 |
| Predicate Devices: | FreeStyle Blood Glucose Monitoring System, K992684, K000582,<br>K012014, K031260<br>Precision PCx 2.2.1 Blood Glucose System, K022941 |
| Description: | The FreeStyle Blood Glucose Monitoring System comprises an<br>electrochemical biosensor glucose reagent test strip, a handheld<br>meter, a quality control solution, a complete Owner's Booklet and a<br>Quick Reference Guide. A lancing device, lancets and a logbook for<br>recording test results are also included with the system.<br><br>When the user inserts a test strip, the meter turns on. The user<br>acquires a blood sample (with the test strip in the meter) by picking<br>up the meter and touching the edge of the test strip at the blood target<br>area, filling the chamber on the strip by capillary action. The meter<br>sounds a tone (beeps) to let the user know that the sample chamber is<br>full and the reaction has begun. When the test is complete, the meter<br>displays the glucose reading on its liquid crystal display (LCD). |
| Intended Use: | The FreeStyle 600 Blood Glucose Monitoring System is intended for<br>in vitro diagnostic use for the quantitative measurement of glucose in<br>fresh capillary, venous, arterial and neonatal whole blood samples.<br>The FreeStyle 600 Blood Glucose Monitoring System is for testing<br>outside the body (in vitro diagnostic use). The FreeStyle 600 Blood<br>Glucose Monitoring System is intended for use in the home and in<br>professional settings to monitor blood glucose levels. |
| Principle of<br>Operation: | The user obtains a blood sample using a conventional lancing<br>technique on the finger, forearm, upper arm, hand, thigh, calf, or<br>palm. The user inserts a test strip into the meter, which turns the<br>meter on. When the strip is touched to the blood drop, the sample<br>chamber on the strip fills by capillary action in approximately 2<br>seconds. The blood sample volume required is approximately 0.3<br>microliters (300 nanoliters), which can be obtained from the finger,<br>forearm, upper arm, hand, thigh, calf, or palm. Test results are<br>displayed in about 15 seconds. The time required to display test<br>results varies depending on the blood glucose concentration<br>(approximately 15 to 45 seconds). |
| | The glucose in the blood sample reacts with the glucose<br>dehydrogenase enzyme to yield gluconolactone, and produces a small<br>electrical current. This current is measured by the FreeStyle meter<br>and displayed as a glucose level. |
| Comparison to<br>Predicate Device: | The FreeStyle 600 Blood Glucose Monitoring System has the same<br>technological characteristics as the predicate device, FreeStyle™<br>Blood Glucose Monitoring System, K992684, K000582, K012014,<br>K031260 and the same intended use as the Precision PCx 2.2.1 Blood<br>Glucose System, K022941. |
| Performance<br>Studies: | The performances of the FreeStyle 600 Blood Glucose Monitoring<br>System was studied in the laboratory and in clinical settings by<br>healthcare professionals. The studies demonstrated that healthcare<br>professionals could obtain blood glucose results that are substantially<br>equivalent to a comparative method. |
| Conclusion: | Results of laboratory and clinical testing demonstrates that the<br>performance of the FreeStyle 600 Blood Glucose Monitoring System<br>when used according to the intended use stated above is acceptable<br>and comparable to the performance to a comparative method.<br>Clinical test results support a determination of substantial<br>equivalence. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

2008 JUL 3

Abbott Diabetes Care, Inc. c/o Ms. Marv Edwards Interim Vice-President Regulatory Affairs 1320 South Loop Road Alameda, CA 94502

Re: k050500

Trade/Device Name: FreeStyle 600 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: May 24, 2005 Received: May 25, 2005

Dear Ms. Edwards:

This letter corrects our substantially equivalent letter of June 27, 2005.

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro 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/dsma/dsmamain.html

Sincerely vours.

Jean M. Cooper, M.S., R.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

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## Indications for Use

K050500 510(k) Number (if known):

Device Name: FreeStyle 600 Blood Glucose Monitoring System

Indications For Use:

The FreeStyle 600 Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle 600 Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle 600 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

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

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

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