RANDOX THERAPEUTIC DRUG CALIBRATOR by RANDOX LABORATORIES, LTD.

The Randox Laboratories Limited Therapeutic Drug Calibrators are based on Iyophilised human r re Tranqox Euboration annou for use in the calibration of therapeutic drug assays. The constituent concentrations of the Randox Laboratories Limited Therapeutic Drug Calibrator are present at 6 levels.

The Randox Laboratories Limited Therapeutic Drug Calibrator should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Description

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Therapeutic Drug Calibrator." It primarily addresses the regulatory approval process and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a performance study report.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market, but it does not include the detailed performance data or study design elements you specified.

Here's why I cannot fulfill your request based on the provided text:

Acceptance Criteria & Reported Performance: The document doesn't define specific numerical acceptance criteria (e.g., accuracy percentages, precision metrics) or provide reported device performance data against such criteria.
Study Details (Sample Size, Data Provenance, Experts, Adjudication): There is no mention of the sample sizes used, whether the data was retrospective or prospective, the country of origin, the number or qualifications of experts, or any adjudication methods.
MRMC Study: The document does not describe a multi-reader multi-case comparative effectiveness study.
Standalone Performance: While the device is a calibrator and would have inherent standalone performance characteristics, the document does not present them.
Ground Truth: The document does not specify the type of ground truth used (e.g., pathology, expert consensus) or how it was established for either test or training sets.
Training Set Sample Size: No information about a training set or its sample size is provided.

This document is a regulatory approval notice, not a scientific study report. For the information you're seeking, a separate study report or regulatory submission detailing the device's validation and performance would be required.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Pauline Armstrong, Ph.D. Regulatory Affairs Randox Laboratories Ltd. Biochemical Manufacturers Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom, BT29 4QY

SEP 1 2 2001

Re: K012318

Trade/Device Name: Therapeutic Drug Calibrator Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical Toxicology Calibrator Regulatory Class: Class II Product Code: DBK Dated: July 11, 2001 Received: July 23, 2001

Dear Ms. Kindell:

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 (OS) 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 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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Page 1 of 1

510(k) Number (if known) NOT KNOWN

Device Name

THERAPEUTIC DRUG CALIBRATOR

Indications For Use :

The Randox Laboratories Limited Therapeutic Drug Calibrator should only 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)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional format1-2-96)

Kenia Alexander Shalton Crozier
(Division Sign-Off)

vision of Clinical Lab 510(k) Number

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.