RANDOX THEOPHYLLINE by RANDOX LABORATORIES, LTD.

The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with theophylline which, in the presence of theophylline antibody solution, rapidly agglutinate. When a sample containing theophylline is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agdutination is inversely dependent on the concentration of theophylline in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of theophylline in the sample.

Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy.

This Application Sheet has been developed for the Hitachi 717 analyser and must 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 the Randox Laboratories Ltd. Theophylline Test Kit. It lacks the kind of detailed study information you requested for Artificial Intelligence/Machine Learning (AI/ML) powered medical devices. The document refers to a "Theophylline Test System" which is an in vitro diagnostic reagent, not an AI/ML device. Therefore, many of the requested fields are not applicable or cannot be extracted from this document.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain acceptance criteria or detailed performance data in a table format. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary regulatory hurdle for 510(k) submissions.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not provided. This is an in vitro diagnostic test for a chemical compound, not an imaging/AI device requiring patient data in the typical sense for an AI model.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of in vitro diagnostic test, the "ground truth" would be established through analytical validation methodologies, not expert consensus on patient data.

4. Adjudication Method

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device, and MRMC studies are typically used for evaluating the impact of AI assistance on human readers interpreting medical images.

6. Standalone (Algorithm Only) Performance Study

The device itself is a standalone in vitro diagnostic test. Its performance would be evaluated through analytical studies (e.g., accuracy, precision, linearity, interference) rather than "algorithm only" performance in the context of AI. The document itself does not contain this detailed performance study data, but rather the FDA's decision based on such submissions.

7. Type of Ground Truth Used

For this type of in vitro diagnostic device, the "ground truth" would be established through:

Reference Methods: Comparison to established, highly accurate analytical methods for theophylline quantification.
Known Concentrations: Testing samples with known, precise concentrations of theophylline.
Clinical Correlation: Demonstrating that the test results correlate with actual patient conditions related to theophylline levels.

The specific "ground truth" for the studies submitted for this 510(k) is not detailed in this clearance letter.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that uses a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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JAN 1 7 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Heather Anderson Regulatory Affairs Randox Laboratories Ltd. Biochemical Manufacturers Ardmore, Diamond Road, Crumlin, Co Antrim United Kingdom BT29 4QY

K011771 Re:

Trade/Device Name: Theophylline Regulation Number: 21 CFR 862.3880 Regulation Name: Theophylline test system Regulatory Class: Class II Product Code: KLS Dated: December 17, 2001 Received: December 20, 2001

Dear Dr. Anderson:

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 1 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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):	Not Known K011771
Device Name:	THEOPHYLLINE

Indications For Use :

Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy.

This Application Sheet has been developed for the Hitachi 717 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K011771

V Prescription Use (Per 21 CFR 801.109)

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

Regulation Number and Section

§ 862.3880 Theophylline test system.

(a)
Identification. A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.(b)
Classification. Class II.