K Number

Device Name

Manufacturer

RANDOX LABORATORIES, LTD.

Date Cleared

2011-03-01

(581 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The Randox Laboratories Ltd. Ecstasy Assay is an in vitro diagnostic test for the detection of MDMA in human urine with a cut off concentration of 500ng/ml, for use on the Unean of the uneath of Mondal analysers in qualitative or semi-quantititive mode. The assay is calibrated against MDMA. This in vitro diagnostic device is intended for prescription use only.

The semi-quantitative mode is for purposes of

(1) enabling laboratories to determine an appropriate difution of the specimen for confirmation by a confirmatory method such as GCMS or
(2) permitting laboratories to establish quality control procedures.

This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromations chemic ടpectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the proliminary result is positive.

The Randox Ecstasy Calibrator Set consists of liquid calibrators containing MDMD. There are 5 levels of calibrator. They have been developed for use in the calibration of Ecstasy assays on the J X day to na" and Amela" analysers. This in vitro diagnostic device in the daily as a line a for prescription use only.

The Randox Ecstasy Controls, level 1 and 2 are liquid controls containing MDMA. There are 2 levels of controls. They have been developed for use in the quality control of the Ecstasy assay on the a X day to na" and annual analysers. This in quality control of the ebstay of the only.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter for the Randox Ecstasy (MDMA) Assay, Calibrator Set, and Controls. It describes the device's intended use and the regulatory approval process. However, it does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.

The document is a regulatory communication, not a performance study report. It confirms that the device is substantially equivalent to legally marketed predicate devices, meaning that its performance is considered comparable to existing, approved devices. The specific performance data and the studies demonstrating that performance are typically found in the submission documents to the FDA, which are not included here.

Therefore,Based on the provided document, I cannot fulfill your request for the following information:

A table of acceptance criteria and the reported device performance: This detailed performance data is not present in the 510(k) clearance letter.
Sample size used for the test set and the data provenance: Not available in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
Adjudication method for the test set: Not available in this document.
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: This device is an in vitro diagnostic assay (a laboratory test) for MDMA in urine, not an AI-powered image analysis tool for human readers. Therefore, an MRMC study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: As an in vitro diagnostic assay, its performance is inherently "standalone" in the sense that it provides a direct analytical result. However, the specific details of performance studies are not in this document.
The type of ground truth used: While the indication for use mentions Gas Chromatography-Mass Spectrometry (GCMS) as the preferred confirmatory method, the document does not explicitly state that GCMS was used as the ground truth for the equivalence study.
The sample size for the training set: Not available in this document. This is an assay, not a machine learning algorithm with a "training set" in the typical sense.
How the ground truth for the training set was established: Not applicable for this type of device in the context of a "training set."

What the document does provide:

Device Name: Randox Ecstasy (MDMA) Assay, Calibrator Set, and Controls.
Indication for Use: In vitro diagnostic test for the detection of MDMA in human urine with a cutoff concentration of 500ng/ml. For use on specific analysers (though the analyser names are obscured as "Unean of the uneath of Mondal" and "J X day to na" and "Amela"). Primarily qualitative or semi-quantitative. Semi-quantitative mode is for determining dilution for confirmatory methods (like GCMS) or for quality control.
Confirmatory Method: States that a more specific alternative chemical method must be used for confirmation, with GCMS being the preferred method.
Prescription Use: The device is for prescription use only.
Ground Truth (implied/recommended confirmatory): GCMS is mentioned as the preferred confirmatory method.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Randox Laboratories, Ltd c/o Dr. Pauline Armstrong Regulatory Affairs 55 Diamond RD. Crumlin, County Antrim United Kingdom BT29 4QY Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAR 0 1 2011

Re: K092275

Trade Name: Randox Ecstasy (MDMA) Assay Regulation Number: 21 CFR 862.3650 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Codes: DKZ, DLJ, LAS Dated: February 22, 2011 Received: February 24, 2011

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D.

Courtney Q. Harper, Ph.D. Acting 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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Indication for Use

510(k) Number (if known):

K092275

Device Name:

ECSTASY ASSAY, CALIBRATOR SET AND CONTROLS LEVEL 1 & 2

. . .

Indication For Use:

Randox Ecstasy Assay

The semi-quantitative mode is for purposes of

(1) enabling laboratories to determine an appropriate difution of the specimen for confirmation by a
confirmatory method such as GCMS or
(2) permitting laboratories to establish quality control procedures.

Randox Ecstasy Calibrator Set

Randox Ecstasy Controls, Level 1 & 2

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K092275

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).