(45 days)
The Cholesterol Profile test system is useful in monitoring LDL, VIDI, and Lp(a)-C cholesterol when present in concentrations HDL. However in some patients Lp(a)-C may not be greater than 2.5 mg/dL. present at concentrations detectable by electrophoresis. Patients at risk include males over the age of 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patient's number of risk factors, treatment can be medication or diet restrictions.
Not Found
The provided text is a letter from the FDA regarding the clearance of the "REP® Cholesterol Profile Kit" and does not contain details about acceptance criteria or specific study data proving the device meets them. This type of document typically confirms that a device has been found substantially equivalent to a legally marketed predicate device, rather than providing the detailed performance study results.
Therefore, I cannot extract the requested information based on the input text. The document states that the device is "substantially equivalent" to predicate devices, implying that its performance is considered comparable, but it does not describe the specific studies or acceptance criteria used to establish that equivalence.
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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 features a stylized graphic of three human profiles facing right, arranged in a stacked, wave-like formation. The profiles are black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 8 1999
Mr. Eric Petersen Vice President Helena Labs 1530 Lindbergh Drive Beaumont, Texas 77704
Re: K992971
Trade Name: REP® Cholesterol Profile Kit Regulatory Class: I Product Code: JHO Dated: August 31, 1999 Received: September 3, 1999
Dear Mr. Petersen:
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 vour 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 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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8 9 510 (k) Number (if known) : REPR Cholesterol Profile Kit Device Name:
Indications for Use:
The Cholesterol Profile test system is useful in monitoring LDL, VIDI, and Lp(a)-C cholesterol when present in concentrations HDL. However in some patients Lp(a)-C may not be greater than 2.5 mg/dL. present at concentrations detectable by electrophoresis. Patients at risk include males over the age of 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patient's number of risk factors, treatment can be medication or diet restrictions.
Jean Corper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KG92971
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.