RANDOX LIQUID CRP CONTROLS by RANDOX LABORATORIES, LTD.

The Randox Laboratories Ltd. C-Reactive Protein Controls are liquid controls containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the control of both accuracy and precision in CRP assays. The control materials are available at two constituent concentrations. The Randox Liquid C-Reactive Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Description

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device. It does not contain information about acceptance criteria, study details, or device performance as typically understood in the context of clinical or diagnostic accuracy studies.

The letter simply states that the Randox Laboratories Ltd. Liquid C-Reactive Protein Controls (Levels II and III) have been found substantially equivalent to a legally marketed predicate device, allowing them to be marketed.

Therefore, for the information requested in your prompt, this document provides:

A table of acceptance criteria and the reported device performance: Not applicable. This document is a clearance letter, not a performance study report. It does not contain acceptance criteria for device performance or reported performance metrics.
Sample size used for the test set and the data provenance: Not applicable. No test set data is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.
Adjudication method: Not applicable. No adjudication method is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a control material, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a control material, not an algorithm.
The type of ground truth used: Not applicable. No ground truth is described.
The sample size for the training set: Not applicable. No training set is described.
How the ground truth for the training set was established: Not applicable. No training set ground truth is described.

In summary, this document is an administrative clearance letter and does not contain the technical study details requested in your prompt.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 2 2004

Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Ardmore, 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY

K040351 Re:

Trade/Device Name: Liquid C-Reactive Protein Controls (Levels II and III) Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class I Product Code: JJX Dated: January 29, 2004 Received: February 12, 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 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 Title 21, Code 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 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 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) 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

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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510(k) Number (if known) NOT KNOWN KOYO351

LIQUID C-REACTIVE PROTEIN CONTROLS (LEVELS II AND III) Device Name:

Indications For Use :

The Randox Liquid C-Reactive Protein 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)

Over-The-Counter Use (Optional format 1-2-96)

Division Sign-Off

vision Sian-

Office of In Vitro Diagno Device Evaiuation an 510(k)

ver-The-Counter Use
(Optional format 1-2-96)

Regulation Number and Section

§ 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.