(262 days)
The FreeStyle Lite 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; and venous 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.
The FreeStyle Freedom Lite 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; and venous 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.
A chemistry change has been made to the FreeStyle Lite Blood Glucose Test Strip. The modified strip is to be marketed under the brand name. FreeStyle Lite, and is intended for use with the following Blood Glucose Monitoring Systems: FreeStyle Lite Blood Glucose Monitoring System, FreeStyle Freedom Lite 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 and venous 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 control program. The FreeStyle Lite Blood Glucose Test Strip is an electrochemical biosensor that fits into a handheld meter. The blood sample volume is approximately 0.3 microliters (300 nanoliters), which can be obtained from the finger, upper arm, or palm. Test results display in accordance with the blood glucose meter's software algorithm (approximately 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 rapid 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.
The provided text describes a 510(k) summary for the FreeStyle Lite Blood Glucose Test Strips, which are part of the FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Monitoring Systems. The submission is for modifications to the test strip chemistry, materials, appearance, and meter turn-on bar.
Here's an analysis of the requested information based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabulated format or provide a direct comparison to "reported device performance." Instead, it describes modifications to existing, cleared devices and indicates that the "intended uses and principles of operation for each of the systems remains the same as previously submitted and cleared for market entry." This implies that the new strips are expected to meet the performance standards of the previously cleared systems.
However, the text indicates the reason for modification and implicitly, the performance benefit:
| Category | Original System Chemistry | Modified System Chemistry (Expected Benefit) |
|---|---|---|
| Chemistry | GDH-PQQ with nPBI mediator | GDH-FAD with MAP mediator |
| Interference | Susceptible to interference from carbohydrates (maltose, lactose, galactose) with GDH-PQQ | Does not show interference in the presence of carbohydrates such as maltose, lactose, and galactose with GDH-FAD (Improved accuracy/reliability in patients consuming these carbohydrates) |
Note: The document does not provide quantitative performance data (e.g., accuracy percentages, bias, precision) for either the original or modified device in this summary. It focuses on the change and its expected benefits regarding carbohydrate interference.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The provided text does not contain information about the number of experts used to establish ground truth or their qualifications. This type of information is typically associated with studies involving diagnostic image interpretation or complex clinical assessments, not typically for glucose monitor performance data as described here.
4. Adjudication Method for the Test Set
The provided text does not contain information about any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more relevant to diagnostic imaging interpretation by human readers.
6. Standalone (Algorithm Only) Performance Study
The text describes an electrochemical biosensor system. The "algorithm" here refers to the software within the meter that interprets the electrochemical signal to display a glucose reading. The entire system (strip + meter) is designed for direct measurement. The text states: "Test results display in accordance with the blood glucose meter's software algorithm (approximately 5 seconds)." While the meter processes the signal algorithmically, the concept of a "standalone algorithm" performance, separate from the physical measurement, isn't directly applicable in the same way it would be for an AI diagnostic imaging algorithm. The performance of the device (strip + meter) is what would be evaluated. The provided text does not present a standalone performance study with specific metrics.
7. Type of Ground Truth Used
The ground truth for blood glucose monitoring systems like this would typically be established by a reference method (e.g., laboratory-grade glucose analyzer, YSI 2300 STAT Plus Glucose & Lactate Analyzer) measuring the glucose concentration in the same blood sample. The provided text does not explicitly state the type of ground truth used, but this is the standard for glucose meter validation.
8. Sample Size for the Training Set
The provided text does not mention a "training set" or its sample size. For traditional medical devices like blood glucose monitors, there isn't typically a "training set" in the machine learning sense. Performance is generally validated through clinical studies and laboratory testing.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the machine learning context, the provided text does not describe how ground truth for a training set was established.
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109260 2
MAY 1 4 2010
510(k) Summary
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 |
| Proprietary Name: | FreeStyle Lite Blood Glucose Test Strips |
| Common Name: | Reagent Test Strips |
| Classification Name: | 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 |
| Predicate Device: | FreeStyle Lite Blood Glucose Monitoring System (K070850) |
| Manufacturing Site: | 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 |
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Description of the Device:
A chemistry change has been made to the FreeStyle Lite Blood Glucose Test Strip. The modified strip is to be marketed under the brand name. FreeStyle Lite, and is intended for use with the following Blood Glucose Monitoring Systems:
- FreeStyle Lite Blood Glucose Monitoring System ●
- FreeStyle Freedom Lite 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 and venous 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 control program. The FreeStyle Lite Blood Glucose Test Strip is an electrochemical biosensor that fits into a handheld meter. The blood sample volume is approximately 0.3 microliters (300 nanoliters), which can be obtained from the finger, upper arm, or palm. Test results display in accordance with the blood glucose meter's software algorithm (approximately 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 rapid 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 Lite Blood Glucose Test Strip chemistry for the new enzyme test strip is changed from GDH-PQQ 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 interference 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.
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Materials:
The modified FreeStyle Lite Blood Glucose Test Strip will utilize the same materials as the current FreeStyle Lite 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 Lite 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 Lite Blood Glucose Test Strip, (that is, the melinex and the silver/silver chloride ink) are exactly the same as those used in the FreeStyle Lite Test Strip, currently being marketed.
Appearance:
The physical appearance of the test strip has been changed to aid customers to distinguish visually between the new enzyme version of the product from the current on-market product.
Meter Turn On Bar:
Blood Glucose Test Strips that are branded as FreeStyle Lite will have a modified turn-on bar but will continue to require the same user interface no coding activities as those currently available in the market.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, resembling a bird in flight. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Abbott Diabetes Care Inc. c/o Arul Sterlin Regulatory Affairs Associate 1360 South Loop Road Alameda, CA 94502
FEB - 1 2011
Re: K092602
Trade Name: Freestyle Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System. Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, LFR Dated: May 08, 2010 Received: May 10, 2010
Dear Arul Sterlin:
This letter corrects our substantially equivalent letter of May 14, 2010.
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); medical device reporting (reporting of medical device-related adverse events)
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Page 2
(21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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 vours.
Signature
Courthey C. Harper, Ph.D. Acting 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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Indication for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: FreeStyle Lite Blood Glucose Monitoring System
Indication For Use:
The FreeStyle Lite 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; and venous 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 X (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) k092602
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Indication for Use
510(k) Number (if known): _ K 092602
Device Name: FreeStyle Freedom Lite Blood Glucose Monitoring System
Indication For Use:
The FreeStyle Freedom Lite 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; and venous 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 _ X (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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092602
page 2 of 2
§ 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.