(127 days)
The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
Not Found
The provided document is an FDA 510(k) clearance letter for the TrueTrack Smart System Blood Glucose Monitoring System dated July 11, 2003. This document confirms the device's substantial equivalence to a legally marketed predicate device but does not contain the detailed study information needed to answer the questions about acceptance criteria and device performance.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This indicates that the detailed study results and performance data would have been part of the original 510(k) submission, not typically included in the clearance letter itself.
Therefore, I cannot provide the requested information based on the given input. To answer these questions, the actual 510(k) submission document or a summary of its contents would be required.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 1 2003
Ms. Karen DeVincent Director of Regulatory Affairs/Quality Assurance Home Diagnostics, Inc. 2400 N.W. 55th Court Fort Lauderdale, FL 33309
Re: K030703
Trade/Device Name: TrueTrack Smart System Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: May 15, 2003 Received: May 19, 2003
Dear Ms. DeVincent:
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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Page _________________________________________________________________________________________________________________________________________________________________________
15030703 510(k) Number (if known):
Device Name: TrueTrack Smart System Blood Glucose Monitoring System
Indications For Use:
The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
Division Sign-Off for Jean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K030703
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUÉ ON ANOTHER PAGE IF NEEDED)
Prescription Use (Oer 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96) .
§ 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.