(49 days)
Cholesterol Reagent is intended for the quantitative determination of serum total cholesterol using Beckman SYNCHRON CX Systems. The results are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood as well as lipid and lipoprotein metabolism disorders.
Not Found
The provided text is related to an FDA 510(k) clearance letter for a "Cholesterol Reagent" and does not contain the detailed information required to answer the questions about acceptance criteria and a study proving a device meets them. This document is a regulatory approval letter, not a technical report or clinical study summary.
Therefore, I cannot provide the requested information from the given input.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 9 1997
Cynthia Shugart President Carolina Liquid Chemistries Corporation 451 West Lambert Road, Suite 207 Brea, California 92821
Re: K971345 Cholesterol Reagent Requlatory Class: I Product Code: СНН April 8, 1997 Dated: Received: April 10, 1997
Dear Ms. Shugart:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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All Property of the Property
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/dsmamain.html".
Sincerely yours,
Steven Litman
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_ 3 of 36
510(k) Number (if known): _
Device Name: Cholesterol Reagent
Indications For Use:
Cholesterol Reagent is intended for the quantitative determination of serum total cholesterol using CX Systems. Beckman SYNCHRON
used in the diagnosis and treatment The results are of disorders involving excess cholesterol in the lipid and lipoprotein metabolism blood as well as disorders.
(PLEASE DO NOT WAITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
(Division Sign-Off)
Division of Clinical Laboratory Devices
15971345
Prescription Use
(Per 21 CFR 801.109)
Over - The - Counter Use_
(Optional Format 1-2-96)
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OR
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.