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.

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.

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.

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.

Device Description

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: FreeStyle 3 Blood Glucose Monitoring System, 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.

AI/ML Overview

Regulatory Submission Type: 510(k) Premarket Notification

Device: FreeStyle Blood Glucose Test Strips (chemistry change) for use with FreeStyle 3, FreeStyle 5, FreeStyle Flash, and FreeStyle Freedom Blood Glucose Monitoring Systems.

Acceptance Criteria and Device Performance:

The provided document describes modifications to the FreeStyle Blood Glucose Test Strip, specifically a chemistry change. However, it does not explicitly state acceptance criteria or present a table of device performance against such criteria. The document focuses on describing the technical changes to the test strip and the regulatory approval process (510(k) clearance) based on substantial equivalence to predicate devices.

Therefore, the requested table cannot be created from the provided text. The submission implies that the performance of the modified strips, in conjunction with the existing meters, is intended to be substantially equivalent to the predicate devices, which would have met specific accuracy and precision standards for blood glucose monitoring systems.

Information Not Present in the Document:

The following information, relevant to a study proving device meets acceptance criteria, is not provided in the given 510(k) summary:

A table of acceptance criteria and the reported device performance.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance. (This is generally not applicable to a blood glucose meter, which is a standalone measurement device rather than an AI-assisted diagnostic imaging tool).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (Again, not directly applicable in the sense of an AI algorithm, but the device itself is a standalone measurement system).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any performance studies.
The sample size for the training set. (Training sets are not typically discussed for this type of device unless there's a machine learning component for a novel analytical method, which isn't detailed here beyond the biosensor chemistry).
How the ground truth for the training set was established.

Summary of Device and Changes:

The submission details a chemistry change to the FreeStyle Blood Glucose Test Strips. The enzyme has been changed from GDH-PQQ with nPBI mediator to GDH-FAD with MAP mediator. This change is noted to address potential interference from carbohydrates like maltose, lactose, and galactose, which could be an issue with GDH-PQQ. Other modifications include a new adhesive system for the spacer tape, a change in the source of carbon ink, and an altered physical appearance of the test strip for visual distinction. The meters themselves, and their underlying software algorithms, have not been modified.

Conclusion:

This 510(k) summary focuses on demonstrating substantial equivalence based on technical modifications to a component (the test strip) of an existing cleared system. It describes the changes to the device but does not include the detailed performance data or study design elements requested, which would typically be found in a separate section of a full regulatory submission. The clearance indicates that the FDA found the modified device to be as safe and effective as the predicate devices, implying that any necessary performance testing would have been conducted and met established standards, even if not explicitly detailed in this summary.

Summary

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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;Tel No. 510-864-4310;Fax No. 510-864-4791;arul.sterlin@abbott.com
ProprietaryName:	FreeStyle Blood Glucose Test Strips
Common Name:	Reagent Test Strips
ClassificationName:	Glucose Dehydrogenase, Glucose, Class II (21 CFR§ 862.1345)Product codes: NBW, LFR;Single Analyte Control Solution, Class I (21 CFR§ 862.1660)Product code: JJX
PredicateDevice:	FreeStyle Blood Glucose Monitoring System (K992684, K000582, K012014,and K031260), and FreeStyle Freedom Blood Glucose Monitoring System(K051839)
ManufacturingSite:	Establishment:Abbott Diabetes Care Inc.1360 South Loop Rd.Alameda, CA 94502Registration Number: 2954323Establishment:Abbott Ireland Diabetes CareDonegal Town, Co. DonegalDonegal Town, IRELAND DonegalRegistration Number: 3007031103

Description of the Device:

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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 (301) 796-5450: 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 (301) 796-5760. 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 (800) 638-2041 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:

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:

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:

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:

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

Paget of 4

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.