(25 days)
The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume.
The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume.
This document is an FDA 510(k) clearance letter for the Randox Lipid Control, stating that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain any information about acceptance criteria or a study proving device performance related to a specific clinical outcome or diagnostic accuracy.
The device described is a "Quality Control Material" for clinical chemistry applications, specifically lipid monitoring. Its stated "Indications For Use" are: "The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume."
Therefore, I cannot provide the requested information from this document. The typical studies and criteria you've asked about (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are relevant to diagnostic devices or AI algorithms that provide clinical insights or diagnoses. This document pertains to a quality control material used to ensure the proper functioning of laboratory equipment.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. P. Armstrong Regulatory Affairs Randox Laboratories, Limited Biochemical Manufacturers Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
AUG 3 0 2002
Re: K022591
Trade/Device Name: Randox Lipid Control Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality Control Material Regulatory Class: I Product Code: JJY Dated: July 30, 2002 Received: August 5, 2002
Dear Dr. Armstrong:
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 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/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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510(k) Number (if known)
Kozz 591
LIPID CONTROLS (Levels I, Il and III) Device Name
Indications For Use :
The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on Iyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume.
The Randox Lipid Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
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)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K023591
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.