(176 days)
The TheraSense Inc. FreeStyle™ Blood Glucose Monitoring System is intended for use in 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.
The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
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, a Quick Reference Guide and a "Getting Started" 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 sample 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).
This document does not contain the information required to fulfill the request. The provided text is a 510(k) summary for the FreeStyle Blood Glucose Monitoring System, detailing its intended use and principle of operation, and stating that changes were made to product labeling regarding alternative site testing. However, it does not include a table of acceptance criteria, reported device performance data, information about sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), or a standalone algorithm performance study. It also lacks specifics on how ground truth was established beyond stating its intended use for "quantitative measurement of glucose."
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DEC 0 5 2001
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: K012014
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 |
2. Legally Marketed Devices to which Substantial Equivalence is Claimed:
| Predicate Device | 510(k) number |
|---|---|
| FreeStyle Blood Glucose Monitoring System | K992684, K994433 |
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, a Quick Reference Guide and a "Getting Started" 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 sample target area, filling the chamber on the strip by capillary action. The meter sounds a tone
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(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 from the forearm, upper arm, finger, hand, calf or thigh. 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, thigh, and hand. 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 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
This 510(k) included changes to the product labeling to add precautions and information about alternative site testing. There are no changes to the product or the intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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DEC 0 5 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Eve A. Conner, Ph. D. Vice President, Quality Assurance and Regulatory Affairs Therasense, Inc. 1360 South Loop Road Alameda, CA 94502
Re: K012014
Trade/Device Name: FreeStyle™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR Dated: November 5, 2001 Received: November 6, 2001
Dear Dr. Conner:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I nus lotter will and h you ding of substantial equivalence of your device to a legally marketed notheation. The I Drivinently sification 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 1 additionally 809.10 for 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers 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/odrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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: 012014
Device Name: FreeStyle Blood Glucose Monitoring System
Indications for Use:
The TheraSense Inc. FreeStyle™ Blood Glucose Monitoring System is intended for use I he TheraSellse Inc. Freebire - Broom in whole blood. It is intended for use by in the qualitiative measurement of grith diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the montoning the enectiveness of a classes mellitus, and it is not intended for use on neonates or arterial blood.
The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand. 114 "
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K12014 |
(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
(Per 21 CFR 801.10)
§ 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.