FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23

K092638 · Abbott Diabetes Care, Inc. · NBW · Jun 15, 2010 · Clinical Chemistry

Device Facts

• Record ID: K092638
• Device Name: FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FreeStyle Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. 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

System comprises blood glucose meter, test strips, and control solutions. Input: 0.3 μL capillary or venous whole blood sample applied to test strip. Principle: Coulometric biosensor technology using FAD-dependent glucose dehydrogenase (GDH-FAD) enzyme; electrons from glucose reaction transferred via mediator to meter; electrical current measured over time proportional to glucose concentration. Output: Quantitative blood glucose level (20-500 mg/dL) displayed on meter. Used by healthcare professionals and patients at home. Output used to monitor diabetes control program effectiveness. Benefits: Rapid, quantitative glucose monitoring for diabetes management.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing of the modified test strip chemistry, including performance comparisons against predicate systems and verification of compatibility with existing meter algorithms.

Technological Characteristics

Electrochemical coulometric biosensor. Materials: Melinex, silver/silver chloride ink, DuPont carbon ink, polymer resin adhesive. Enzyme: GDH-FAD. Mediator: MAP (n-methyl pyridine). Sample volume: 0.3 microliters. Connectivity: Standalone test strip for handheld meter. Sterilization: Not specified.

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood (finger, upper arm, palm) for patients with diabetes mellitus. Intended for use by healthcare professionals and patients at home to monitor diabetes treatment effectiveness. Contraindicated for neonates, arterial blood, and 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 (k031260)
• FreeStyle Freedom Blood Glucose Monitoring System (k051839)

Submission Summary (Full Text)

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## 510(k) Summary

# JUN 1 5 2010

According to the requirements Per 21 CFR §807.92, the following information is 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<br>Name: | FreeStyle Blood Glucose Test Strips |
| Common Name: | Reagent Test Strips |
| Classification<br>Name: | Glucose Dehydrogenase, Glucose, Class II (21 CFR§ 862.1345)<br>Product codes: NBW, LFR;<br>Single Analyte Control Solution, Class I (21 CFR§ 862.1660)<br>Product code: JJX |
| Predicate<br>Device: | FreeStyle Blood Glucose Monitoring System (K992684, K000582, K012014,<br>and K031260), and FreeStyle Freedom Blood Glucose Monitoring System<br>(K051839) |
| Manufacturing<br>Site: | Establishment:<br>Abbott Diabetes Care Inc.<br>1360 South Loop Rd.<br>Alameda, CA 94502<br>Registration Number: 2954323<br>Establishment:<br>Abbott Ireland Diabetes Care<br>Donegal Town, Co. Donegal<br>Donegal Town, IRELAND Donegal<br>Registration Number: 3007031103 |

## Description of the Device:

A chemistry change has been made to the FreeStyle Blood Glucose Test Strip. The modified strip is to be marketed under the brand name, FreeStyle, and is intended for use with the following Blood Glucose Monitoring Systems:

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- FreeStyle 3 Blood Glucose Monitoring System 0
- . FreeStyle 5 Blood Glucose Monitoring System
- FreeStyle Flash Blood Glucose Monitoring System .
- FreeStyle Freedom Blood Glucose Monitoring System .

The meters and other system components contained within these systems have not been modified. Each of the aforementioned blood glucose monitoring systems are comprised of a handheld glucose meter, glucose reagent test strips, a quality control solution, a lancing device, lancets, lancing cap, and labeling for performing a blood glucose test. The intended uses and principles of operation for each of the systems remains the same as previously submitted and cleared for market entry. The systems utilize coulometric biosensor technology to quantitatively measure glucose concentration in whole blood samples. The systems are intended for selfmonitoring of glucose in capillary whole blood. The primary users are persons with diabetes. The systems are meant to aid in diabetes management and for healthcare professionals to aid in monitoring the effectiveness of diabetes treatment. The FreeStyle Blood Glucose Test Strip is an electrochemical biosensor that fits into a handheld meter. When the strip is touched to a blood drop, the sample chamber on the strip fills by capillary action. The blood sample volume is approximately 0.3 microliters (300 nanoliters), which can be obtained from the finger, or palm or upper arm. Test results display in accordance with the blood glucose meter's software algorithm (approximately 15 seconds, or 5 seconds). The internal volume of the test strip is precisely controlled, and a blood glucose result will not be displayed on the meter unless the internal sample chamber is filled. Once the measurement begins, the glucose is rapidly oxidized by the reagents that are present in the inside of the sample chamber. The electrochemical signal that results from this process depends only on the total amount of glucose present. The reagent chemistry enables electrolysis of glucose in the blood sample. A mediator molecule shuttles electrons rapidly between a glucose-oxidizing enzyme and the working electrode on the strip. The mediator is capable of reacting rapidly with both the electrode and the enzyme, resulting in a fast reaction time and minimizing the total amount of mediator required. The small mediator load results in high accuracy at the low end of the glucose measurement range.

#### Description of Modifications:

The modifications to the system are comprised of changes to the blood glucose test strip which include chemistry, materials, appearance, and modification of the meter turn-on bar.

### Chemistry:

The FreeStyle Blood Glucose Test Strip chemistry for the new enzyme test strip is changed from GDH-POO with nPBI mediator (Osmium complex with n-pentyl benzimidazole ligand), to GDH-FAD with MAP mediator (ligand of mediator has changed to n-methyl pyridine). GDH-FAD does not show intereference in the presence of carbohydrates such as maltose, lactose and galactose as compared with assays performed with GDH-PQQ. The n-pentyl benzimidazole

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ligand of the mediator has changed to n-methyl pyridine and a new source of carbon ink is used to make the new enzyme chemistry compatible with on-market meters.

#### Materials:

The modified FreeStyle Blood Glucose Test Strip will utilize the same materials as the current FreeStyle Blood Glucose Test Strip, with the exception of the spacer tape and source of carbon. A new adhesive system is utilized as the spacer tape. The new spacer tape uses the exact same base polymer resin as the current FreeStyle Test Strip adhesive coupled with a different crosslinking agent. Screen printed carbon electrodes are made using DuPont carbon ink instead of Ercon carbon. All other materials in the modified FreeStyle Blood Glucose Test Strip, (that is, the melinex and the silver/silver chloride ink) are exactly the same as those used in the FreeStyle Test Strip, currently being marketed.

#### Appearance:

The physical appearance of the test strip has been changed to aid customers in distinguishing visually between the new enzyme version of the product and the current on-market product.

#### Meter Turn On Bar:

Blood Glucose Test Strips that are branded, FreeStyle, will have a modified turn on bar but will continue to require the same user interface coding activities as those currently available in the market. Only those strips meeting the manufacturing calibration slope and intercept for current FreeStyle meters (Code 16) will enter the market.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN 15 2007

Abbott Diabetes Care, Inc. c/o Arul Sterlin Regulatory Affairs Associate 1360 South Loop Road Alameda, CA 94502

Re: k092638

> Trade/Device Name: FreeStyle 3 Blood Glucose Monitoring System, FreeStyle 5 Blood Glucose Monitoring System, FreeStyle Flash Blood Glucose Monitoring System, 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: June 05, 2009 Received: June 07, 2009

Dear Arul 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. Iisting 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

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/MedicalDevices/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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, 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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510(k) Number (if known): _ Ko92638

Device Name: FreeStyle 3 Blood Glucose Monitoring System

Indication For Use:

The FreeStyle 3 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. 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 (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)

Signature

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

510(k) K092638

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510(k) Number (if known): _Ko92638

Device Name: FreeStyle 5 Blood Glucose Monitoring System

Indication For Use:

The FreeStyle 5 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. 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 (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)

Ous

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

510(k) K092638

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510(k) Number (if known): 《092638

Device Name: FreeStyle Flash Blood Glucose Monitoring System

Indication For Use:

The FreeStyle Flash Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. 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 (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)

Signature

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

510(k) K092638

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510(k) Number (if known): _ K o 9 2 6 3 &

Device Name: FreeStyle Freedom Blood Glucose Monitoring System

Indication For Use:

The FreeStyle Freedom Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. 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 (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 (OVD)

signature

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

510(k) K092638

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