(129 days)
The Excelsior blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX blood glucose meters. Excelsior test strips, when used with the Home Diagnostics, Inc. Prestige LX blood glucose meters, quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.
Excelsior blood glucose test strips for use with the Home Diagnostics, Inc. Prestige LX Dood glucose system, and Prestige IQ blood glucose system.
The provided document is an FDA 510(k) clearance letter for a medical device (Excelsior Blood Glucose Test Strips). It states that the device is substantially equivalent to a legally marketed predicate device.
This document does not contain the specific information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
FDA 510(k) clearance letters primarily focus on the determination of substantial equivalence, not a detailed breakdown of clinical study results or technical performance metrics used in the study submitted to support the 510(k). The detailed performance data would typically be found within the 510(k) submission itself, which is not provided here.
Therefore, I cannot provide the requested information based on the given text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters, encircling the eagle symbol. The eagle is drawn in a simple, bold line style, and the overall design is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 5 2002
Mr. Stephen C. Pearson Program Manager Chay Medical, LLC 3257 Route 128 Calistoga, CA 94515
K013342 Re:
Trade/Device Name: Excelsior Blood Glucose Test Strips for use with the Home Diagnostics. Inc. Prestige LX Blood Glucose System, and Prestige IO Blood Glucose System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: October 8, 2001 Received: October 9, 2001
Dear Mr. Pearson:
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 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/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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510(k) Number (if known): KO13342
Device Name: Excelsior blood glucose test strips for use with the Home Diagnostics, Inc. Prestige LX Dood glucose system, and Prestige IQ blood glucose system.
Indications For Use:
The Excelsior blood glucose test strips are intended for both professional and home use when used with The Excelsior blood glucose test suips are incoluse Incose meters. Excelsior test strips, when whole blood the Home Diagnostics, Inc. I resuge DX of 110stitistively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.
Dean Coogn
(Division Sign-Off)
Division of Clinical Laboratory Devices
$10(k) Number K013342
(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
(Optional Format 1-2-96)
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§ 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.