(242 days)
Not Found
No
The description focuses on electrochemical biosensing and basic meter functionality, with no mention of AI/ML terms or capabilities.
No.
The device is described as a "Blood Glucose Monitoring System" and "Diabetes Management System" which aids in monitoring and managing diabetes by measuring glucose levels, not directly treating a medical condition.
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 comprises a handheld meter, test strips, and other physical components, indicating it is a hardware-based system, not software-only.
Based on the provided text, the FreeStyle Blood Glucose Monitoring System and the FreeStyle Tracker Diabetes Management System are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: Both systems are intended for the "quantitative measurement of glucose in whole blood." This involves testing a biological sample (blood) outside of the body to obtain a quantitative result.
- Device Description: The description explicitly mentions an "electrochemical biosensor glucose reagent test strip" and a "blood sample." This confirms that the device interacts with a biological sample and uses a reagent to perform the measurement.
- Purpose: The intended use is to "aid in monitoring the effectiveness of diabetes control program," which is a diagnostic purpose related to managing a medical condition.
While the text states it's "not intended for the diagnosis of or screening for diabetes mellitus," this doesn't preclude it from being an IVD. IVDs encompass a wide range of tests performed on biological samples, including those used for monitoring and managing existing conditions, not just initial diagnosis.
N/A
Intended Use / Indications for Use
The TheraSense, Inc., FreeStyle Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Additionally, the TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in home and clinical setting to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program.
The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
Device Description
The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's Booklet and Quick Reference Guide. A lancing device, lancets and a logbook for recording test results are also included with the system.
When the user inserts a test strip, the meter turns on. The user acquires a blood sample (with the test strip in the meter) by picking up the meter and touching the edge of the test strip at the blood target area, filling the chamber on the strip by capillary action. The meter sounds a tone (bee) to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its liguid crystal display (LCD).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, forearm, upper arm, thigh, calf and hand.
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home, home and clinical setting
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)
The clinical study data demonstrate that during times of rapid glucose change, palm and fingertip glucose values are the same. This study confirms results in several published reports which show the equivalence of fingertip and palm glucose test results under conditions of rapid glucose change. The combination of TheraSense's confirmatory study and published support TheraSense's proposed labeling change to recommend the palm of the hand as an alternative test site even under conditions of rapidly changing blood glucose.
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.
K992684, K000582, K012014, K020866
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.
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DEC 1 9 2003
TheraSense Inc.
Premarket Notification Labeling Modification FreeStyle Blood Glucose Monitoring System April 17, 2003
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is
Not Assigned K03/260
1. Device Name
| Classification Name: | Glucose Test System (§ 862.1345) |
|---|---|
| Common/Usual Name: | Blood Glucose Meter and Reagent Test Strips |
| Proprietary Names: | Freestyle™Blood Glucose Monitoring System |
| And FreeStyle Tracker Diabetes Management System |
Legally Marketed Devices to which Substantial equivalence is Claimed: 2.
| Predicate Device | 510(k) Number |
|---|---|
| FreestyleTM Blood Glucose Monitoring System | K992684 |
| K000582 | |
| K012014 | |
| FreeStyle Tracker Diabetes Management System | K020866 |
3. Device Description
The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's Booklet and Quick Reference Guide. A lancing device, lancets and a logbook for recording test results are also included with the system.
When the user inserts a test strip, the meter turns on. The user acquires a blood sample (with the test strip in the meter) by picking up the meter and touching the edge of the test strip at the blood target area, filling the chamber on the strip by capillary action. The meter sounds a tone (bee) to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its liguid crystal display (LCD).
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc.
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TheraSense Inc.
4. Intended Use of the Device
FreeStyle Blood Glucose Monitoring System
The TheraSense, Inc., FreeStyle Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
FreeStyle Tracker Diabetes Management System
The TheraSense, Inc., FrecStyle Tracker Diabetes Management System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Additionally, the TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in home and clinical setting to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program.
The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
Principle of Operation న్.
The user obtains a blood sample using a conventional lancing technique on the finger or arm. The user inserts a test strip into the meter, which turns the meter on. When the strip is touched to the blood drop, the sample chamber on the strip tills by capillary action in approximately 2 seconds. The blood sample volume required is approximately 0.3 microliters (300 nanoliters), which can be obtained from the finger or other areas of the body such as the arm. Test results are displayed in about 15 seconds. The time required to
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc.
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TheraSense Inc.
Premarket Notification Labeling Modification FreeStyle Blood Glucose Monitoring System April 17, 2003
display test results varies depending on the blood glucose concentration (approximately 15 to 45 seconds).
The glucose in the blood sample reacts with the glucose Dehydrogenase enzyme to yield gluconolactone, and produces a small electrical current. This current is measured by the FreeStyle meter and displayed as a glucose level.
6. Conclusion Drawn from Clinical Test Demonstrating Substantial Equivalence
The clinical study data demonstrate that during times of rapid glucose change, palm and fingertip glucose values are the same. This study confirms results in several published reports which show the equivalence of fingertip and palm glucose test results under conditions of rapid glucose change. The combination of TheraSense's confirmatory study and published support TheraSense's proposed labeling change to recommend the palm of the hand as an alternative test site even under conditions of rapidly changing blood glucose.
Proprietary Data: This document and the information contained herein may not be reproduce used or disclosed without prior written consent of TheraSense, Inc.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 9 2003
Ms. Donna K. Templeman Director, Regulatory Affairs TheraSense, Inc. 1360 South Loop Road Alameda, CA 94502
K031260 Re:
Trade/Device Name: FreeStyle Blood Glucose Monitoring System and Tracker Diabetes Management System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: LFR; JJX Dated: September 16, 2003 Received: September 22, 2003
Dear Ms. Templeman:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin 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 information about the application of labeling requirements to your device: or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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TheraSense Inc.
Premarket Notification Labeling Modification FreeStyle Blood Glucose Monitoring System April 17, 2003
Intended Use Statement
510(k) Number (if known):
Device Name:
K03/260
FreeStyle Blood Glucose Monitoring System and Tracker Diabetes Management System
Indication for Use:
FreeStyle Blood Glucose Monitoring System
The TheraSense, Inc., FreeStyle Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
FreeStyle Tracker Diabetes Management System
The TheraSense, Inc., FreeStyle Tracker Diabetes Management System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Additionally, the TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in home and clinical setting to aid people with diabetes and healthcare professionals in the review, and evaluation of historical blood glucose test results to support an effective diabetes management program.
The TheraSensc, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use
Use
Carol C. Benson/s Jean Cooper, DVM
Division Sign-Off
(Optional Format 1-2-96)
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031260
Proprietary Data: This document and the information contained herein may not be reproduced used or disclosed without prior written consent of TheraSense, Inc.
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