(157 days)
Not Found
No
The description details a standard electrochemical biosensor system with a meter displaying results. There is no mention of AI, ML, or any computational analysis beyond basic signal processing for glucose measurement.
No
This device is a blood glucose monitoring system, which is an in vitro diagnostic device used to measure glucose levels. It is not designed to directly treat or cure a medical condition, which is the primary function of a therapeutic device. It aids in monitoring a disease, but does not provide therapy.
Yes
The device is intended for "in vitro diagnostic use" and aids in "monitoring the effectiveness of diabetes control," which are diagnostic actions, even though it's explicitly stated it's "not intended for use in the diagnosis of or screening for diabetes mellitus."
No
The device description explicitly lists hardware components such as a handheld meter, test strips, and a lancing device, indicating it is a hardware-based system with some software functionality, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement explicitly states: "The FreeStyle System is intended for use outside the body (in vitro diagnostic use)..." and "The FreeStyle "" System is intended for use outside the body (in vitro diagnostic use)."
This clearly indicates that the device is designed to be used on samples taken from the body (blood) and analyzed outside of the body to provide diagnostic information (glucose levels).
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 fresh whole capillary blood. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The FreeStyle "" System is intended for use outside the body (in vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates (newborns) or arterial blood.
The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger or arm.
Product codes (comma separated list FDA assigned to the subject device)
LFR
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 a 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 (beeps) 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 liquid crystal display (LCD).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger or arm
Indicated Patient Age Range
Not intended for use on neonates (newborns)
Intended User / Care Setting
people with diabetes 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)
Performance testing of the FreeStyle Blood Glucose Monitoring System demonstrated that the system meets the performance requirements for its intended use. Laboratory testing was conducted in accordance with FDA draft guidance "Review Criteria for Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology. The results demonstrate that the FreeStyle Blood Glucose Monitoring System satisfies all performance requirements.
A multi-center controlled clinical study was conducted to demonstrate accuracy and precision of the FreeStyle System when used by lay users with diabetes mellitus and by experienced technicians. Blood glucose results obtained with FreeStyle and with the predicate device, FastTake were compared to a standard laboratory test for measuring blood glucose.
The clinical data demonstrate that the performance of FreeStyle correlates well with the laboratory method. When the blood glucose results were analyzed by the Clarke Error Grid Analysis, the System produced results within the range of clinical acceptable accuracy. The data also demonstrate that the FreeStyle performs equivalently to the predicate device, FastTake. The data also demonstrate that the system performs equivalently in the hands of the lay user and a trained technician.
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.
K970707, K930979, K980731, K982002, K982076
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
TheraSense Inc.
JAN 1 4 2000
Image /page/0/Picture/4 description: The image shows the logo for TheraSense. The logo features a stylized human figure with outstretched arms, forming the letter 'S'. To the right of the figure is the word "THERASENSE" in bold, sans-serif font. Below the company name is the tagline "The Technology of Caring" in a smaller, italicized font.
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
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 |
Legally Marketed Devices to which 2. Substantial Equivalence is Claimed:
| Predicate Device | 510(k) number |
|---|---|
| FastTake | K970707 |
| Accu-Chek Advantage with Comfort Curve Test | |
| Strips | K930979 |
| K980731 | |
| K982002 | |
| AtLast | K982076 |
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
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc..
1
TheraSense Inc.
Booklet and a 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 (beeps) 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 liquid crystal display (LCD).
4. Intended Use of the Device
The TheraSense FreeStyle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh whole capillary blood. The FreeStyle System is intended for use outside the body (in vitro diagnostic use) by health care professionals and people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and it is not intended for use on neonates or with arterial blood samples.
5. Principle of Operation
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 fills 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 display test results varies depending on the blood glucose concentration (approximately 15 to 45
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc..
2
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. Summary of Data Demonstrating Substantial Equivalence
Performance testing of the FreeStyle Blood Glucose Monitoring System demonstrated that the system meets the performance requirements for its intended use. Laboratory testing was conducted in accordance with FDA draft guidance "Review Criteria for Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology. The results demonstrate that the FreeStyle Blood Glucose Monitoring System satisfies all performance requirements.
A multi-center controlled clinical study was conducted to demonstrate accuracy and precision of the FreeStyle System when used by lay users with diabetes mellitus and by experienced technicians. Blood glucose results obtained with FreeStyle and with the predicate device, FastTake were compared to a standard laboratory test for measuring blood glucose.
The clinical data demonstrate that the performance of FreeStyle correlates well with the laboratory method. When the blood glucose results were analyzed by the Clarke Error Grid Analysis, the System produced results within the range of clinical acceptable accuracy. The data also demonstrate that the FreeStyle performs equivalently to the predicate device, FastTake. The data also demonstrate that the system performs equivalently in the hands of the lay user and a trained technician.
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7. Conclusions Drawn from Nonclinical and Clinical Tests
Laboratory and clinical studies demonstrate that the TheraSense FreeStyle Blood Glucose Monitoring System is equivalent to the FastTake Blood Glucose Monitoring System and is safe and effective for its intended use.
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc..
000368
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 4 2000
Eva A. Conner, Ph.D. Vice President, Ouality Assurance/Regulatory Affairs Therasense. Inc. 1360 South Loop Road Alameda, California 94502
Re: K992684
Trade Name: FreeStyle™ Blood Glucose Monitoring System Regulatory Class: II Product Code: LFR Dated: November 8, 1999 Received: November 9, 1999
Dear Dr. Connor:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895, A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number: K992684
Device Name: FreeStyle™ Blood Glucose Monitoring System
Indications for Use:
The TheraSense Inc. FreeStyle™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh whole capillary blood. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The FreeStyle "" System is intended for use outside the body (in vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates (newborns) or arterial blood.
The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger or arm.
Cospes
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992684
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Uses
unter Uses
(Per 21 CFR 801.109)