(21 days)
The Prestige LX 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
This document is a 510(k) clearance letter for the Prestige LX Blood Glucose Test System from the FDA, dated September 24, 1999. It states that the device is substantially equivalent to legally marketed predicate devices. Unfortunately, this document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.
Here's why and what information is missing:
- Acceptance Criteria and Device Performance: The letter confirms substantial equivalence but does not list specific performance metrics (e.g., accuracy, precision) or their corresponding acceptance criteria for the Prestige LX system.
- Study Details: There is no mention of the study design, sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any testing performed. This type of information would typically be found in the 510(k) submission itself, not the FDA's clearance letter.
- MRMC, Standalone, Training Set: These are specific types of studies or data points related to performance evaluation, none of which are discussed in this document.
In summary, based only on the provided FDA clearance letter (K992988) for the Prestige LX Blood Glucose Test System:
I cannot provide the requested information about acceptance criteria and the detailed study that proves the device meets those criteria. This document is a regulatory approval notice and does not contain the technical performance data or study methodology. To obtain that information, one would typically need to review the original 510(k) submission documentation, which is not provided here.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 4 1999
Ms. Karen DeVincent Director of Regulatory Affairs Home Diagnostics, Inc. 2400 N.W. 55th Court Fort Lauderdale, Florida 33309
Re: K992988
Trade Name: Prestige LX Blood Glucose Test System Regulatory Class: II Product Code: CGA Dated: September 3, 1999 Received: September 3, 1999
Dear Ms. DeVincent:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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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 Gutman
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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Page _ of _
510(k) Number (if known): K992988
Prestige LX Blood Glucose Test System Device Name: _____
Indications For Use:
The Prestige LX 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.
Dean Cooper
cevices sion of Clini 510(k) Numbe
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OK
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Oer 21 CFR 801.109) ✓
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.