(120 days)
The Randox Laboratories Ltd. Immunoassay 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 a wide range of laboratory applications, particularly Immunoassay analysis. The product is available at three constituent concentrations. Each level is available in a 5ml final re-constituted volume. The Randox Assayed Immunoassay Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Ltd. Immunoassay Controls (Levels I, II, and III) are based on lyophilised human serum.
The provided text is a 510(k) clearance letter from the FDA for "Assayed Immunoassay Controls" from Randox Laboratories Ltd. This document does not describe acceptance criteria or a study proving device performance as typically expected for an AI/ML or imaging device. Instead, it is a regulatory document confirming substantial equivalence of a quality control material to a predicate device.
Therefore, I cannot extract the requested information as it is not present in the provided text. The device in question is a laboratory quality control material, not a device that would typically undergo the kind of performance studies involving AI, human readers, or ground truth establishment that your questions imply.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 6 2004
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Ardmore, 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
K040379 Re:
Trade/Device Name: Assayed Immunoassay Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: May 11, 2004 Received: May 13, 2004
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 r ou may, aterer, mains 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back of Federal Regulations (CFR), Parts 800 to 895. 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 r rouse be actived a determination that your device complies with other requirements of the Act that I Dr Hao Intatutes and regulations administered by other Federal agencies. You must or any I edelar states and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I fills letter will anow you to begin maxicoang your and equivalence of your device to a legally premail.cr notication. The PDF interessification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, II you desire specific miromation assisted of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Viro Diagliostic Derroo Driaa by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may oodain other general 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,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K040379 510(k) Number:
Assayed Immunoassay Controls Device Name:
Indications For Use:
The Randox Laboratories Ltd. Immunoassay Controls (Levels I, II, and III) are based on The Trandox Laboratorios Ltd. Have been developed for the control of both accuracy and lyophilisou namin obram and applications, particularly Immunoassay analysis. The proofolon in similable at three constituent concentrations, Each level is available in a 5ml final re-constituted volume.
The Randox Assayed Immunoassay Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benner
Division Sign Off
Division Sign-Off
Office of In Vitro Diagno
510(k) K040379
Page 1 of
§ 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.