(307 days)
For the quantitative measurement of glucose levels in human whole blood by people with diabetes at home and by health care workers in a professional setting.
Not Found
I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria, study details, and performance of the HMD Biomedical GlucoLeader™ Blood Glucose Test System. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device but does not include the specifics of the performance study or clinical trial results.
To answer your request, I would need a document such as a clinical study report, a detailed summary of safety and effectiveness, or the full 510(k) submission which would typically contain such information. This current document only states that the device is cleared for marketing based on substantial equivalence.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract image. The abstract image resembles an eagle or bird-like figure. The logo is black and white.
AUG - 4 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
HMD Biomedical, Inc. c/o Jeffrey Fleishman Immunostics, Inc. 3505 Sunset Avenue Ocean, New Jersey 07712
Re: K023279
Trade/Device Name: HMD Biomedical GlucoLeader™ Blood Glucose Test System Regulation Number: 21 CFR § 862.1345 Regulation Name: System, Test, Blood Glucose, Over-the-Counter Regulatory Class: II Product Code: NBW, CGA Dated: May 2, 2003 Received: May 30, 2003
Dear Mr. Fleishman:
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). 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.
{1}------------------------------------------------
Page 2 -
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
{2}------------------------------------------------
510(k) Number (if known): K023279
HMD Biomedical's GlucoLeader™ Value Device Name:
Indications for Use: For the quantitative measurement of glucose levels in human multations for USe. For the qualifishing and by health care workers in a professional setting.
(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
Sean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safet
510(k) K023279
§ 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.