(262 days)
Not Found
No
The description focuses on the electrochemical biosensor technology and a simple software algorithm for displaying results, with no mention of AI or ML.
No
The device is described as an aid in monitoring the effectiveness of a diabetes control program, not for therapeutic intervention directly. It measures glucose levels, which is for information and management, not direct treatment.
No
The "Intended Use / Indications for Use" section explicitly states: "It is not intended for the diagnosis of or screening for diabetes mellitus..."
No
The device description explicitly states that the system is comprised of a handheld glucose meter, glucose reagent test strips, quality control solution, lancing device, lancets, lancing cap, and labeling, in addition to the software algorithm. This indicates the presence of significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in capillary whole blood... and venous blood." This involves testing a biological sample (blood) outside of the body to obtain information about a person's health status (glucose levels).
- Device Description: The description details the components of the system, including "glucose reagent test strips" and the use of "coulometric biosensor technology" and "electrochemical biosensor" to measure glucose in blood samples. This further confirms it's designed for in vitro testing.
- Definition of IVD: An IVD is a medical device used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device fits this definition by measuring glucose in blood for monitoring diabetes.
N/A
Intended Use / Indications 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
Device Description
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.
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
capillary whole blood from the finger, upper arm and palm; and venous blood
Indicated Patient Age Range
Not Found. Not intended for use on neonates.
Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
FreeStyle Lite Blood Glucose Monitoring System (K070850)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 94502 | |
| Registration Number: 2954323 | |
| Establishment: | |
| Abbott Ireland Diabetes Care | |
| Donegal Town, Co. Donegal | |
| Donegal Town, IRELAND Donegal | |
| Registration Number: 3007031103 |
1
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
2
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.
3
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.
4
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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(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
6
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
7
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
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