Randox Cocaine Metabolite Assay: The Randox Laboratories Ltd. Cocaine Assay is an in vitro diagnostic test for the qualitative and semiquantitative detection of Cocaine in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for Benzovlecgonine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Cocaine use or overdose. The Randox Cocaine Metabolite Assay has been developed for use on the RX series analysers, which includes the RX Daytona and the RX Imola. 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 dilution 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 must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Randox Multidrug Calibrator Set: The Randox Multidrug Calibrator Set consists of liquid calibrators containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Cocaine and Methadone assays on the RX series analysers, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

Randox Multidrug Controls, Level 1 & 2: The Randox Multidrug Controls, level 1 and 2 are liquid controls containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Cocaine and Methadone assays on the RX series analysers, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

Device Description

Not Found

AI/ML Overview

This document describes the FDA's 510(k) clearance for the Randox Cocaine Metabolite Assay, Multidrug Calibrator Set, and Multidrug Controls Level 1 & 2. The clearance indicates that the device is substantially equivalent to a predicate device. However, the provided text does not contain the detailed study information required to fully address your request.

The document primarily focuses on the regulatory approval, intended use, and general characteristics of the device. It states that the Randox Cocaine Metabolite Assay is for the qualitative and semiquantitative detection of Cocaine in human urine, with a cutoff of 300 ng/ml for Benzoylecgonine. It also mentions the Multidrug Calibrator Set and Multidrug Controls for Amphetamine, Barbiturates, Cocaine, and Methadone assays.

Therefore, I cannot provide the specific details regarding acceptance criteria, device performance, study design, sample sizes, expert qualifications, or ground truth establishment based solely on the provided text.

To illustrate what such a response would look like if the information were available, and to help you understand what to look for in other documents, here's a template outlining the kind of information that is typically found in a submission to demonstrate acceptance criteria and device performance:

Hypothetical Section based on typical FDA submissions (Information NOT present in the provided document):

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (e.g., based on predicate device or clinical needs)	Reported Device Performance (Randox Cocaine Metabolite Assay)
Qualitative Mode
Sensitivity (at 300 ng/mL cut-off)	≥ 95%	[e.g., 98.5% (95% CI: 97.2%-99.3%)]
Specificity (at 300 ng/mL cut-off)	≥ 95%	[e.g., 97.8% (95% CI: 96.0%-98.9%)]
Accuracy (overall agreement)	≥ 95%	[e.g., 98.1% (95% CI: 96.9%-99.0%)]
Semi-quantitative Mode
Accuracy (agreement within 20% of GC/MS)	≥ 90%	[e.g., 93.2% (95% CI: 91.5%-94.7%)]
Precision (CV%)	≤ 10% (Intra-assay), ≤ 15% (Inter-assay)	[e.g., Intra-assay: 5.2%, Inter-assay: 8.7%]
Limit of Detection (LOD)	≤ 150 ng/mL	[e.g., 100 ng/mL]
Cut-off Validation (agreement at 300 ng/mL vs. GC/MS)	≥ 95%	[e.g., 98.0%]

2. Sample Sizes and Data Provenance for Test Set

Sample Size for Test Set: [e.g., 500 urine samples (250 positive for Benzoylecgonine by GC/MS, 250 negative for Benzoylecgonine by GC/MS)]
Data Provenance: [e.g., Retrospective collection from a diverse patient population undergoing routine drug screening at clinical laboratories in the United States and Europe.]

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Number of Experts: [e.g., 3 independent board-certified clinical toxicologists]
Qualifications of Experts: [e.g., Each toxicologist had a minimum of 15 years of experience in forensic toxicology and drug assay validation, specializing in mass spectrometry methods.]

4. Adjudication Method for Test Set

Adjudication Method: [e.g., Discrepancies between the initial two GC/MS results and/or clinical records were independently reviewed by a third clinical toxicologist. Final ground truth was established by consensus among at least two of the three experts.]

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

MRMC Study Conducted?: [e.g., No, this is an in vitro diagnostic device for automated analysis; therefore, human reader assistance studies are not typically applicable.] (If it were applicable, you would see an effect size like: "Human readers' accuracy improved by X% (e.g., 10%) with AI assistance compared to without AI assistance, achieving an average AUC increase of Y (e.g., 0.05).")

6. Standalone Performance Study

Standalone Performance Study Conducted?: Yes. The clinical performance study detailed in section 1 evaluated the device's performance (sensitivity, specificity, accuracy) independently without human intervention, as it is an automated assay.

7. Type of Ground Truth Used (Test Set)

Type of Ground Truth: Gold standard Gas Chromatography/Mass Spectrometry (GC/MS) results for Benzoylecgonine concentration in urine samples, correlated with clinical review of patient records where applicable.

8. Sample Size for Training Set

Sample Size for Training Set: [e.g., Not applicable for this type of immunoassay-based device in the same way it would be for a typical machine learning algorithm. The "training" phase for such an assay involves extensive analytical validation, calibration curve generation, and quality control optimization using hundreds to thousands of samples with known analyte concentrations for reagent development, instrument optimization, and establishment of performance specifications.]

9. How Ground Truth for Training Set Was Established

Ground Truth for Training Set: [e.g., For immunoassay development, ground truth is typically established through serial dilutions of certified reference materials, spiked samples with known concentrations of Benzoylecgonine, and samples cross-validated against GC/MS during the assay development and optimization phases. This ensures reagent specificity, linearity, and accurate quantitation.]

Summary of Information from the Provided Document:

Device Name: Randox Cocaine Metabolite Assay, Multidrug Calibrator Set, and Multidrug Controls Level 1 & 2.
Intended Use (Cocaine Assay): In vitro diagnostic test for qualitative and semiquantitative detection of Cocaine (Benzoylecgonine) in human urine.
Cut-off (Cocaine Assay): 300 ng/ml for Benzoylecgonine.
Semi-quantitative Use Cases: Determining appropriate dilution for GC/MS confirmation and establishing quality control.
Confirmatory Method: Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method.
Platform: RX series analysers (RX Daytona and RX Imola).
Prescription Use: Intended for prescription use only.
Multidrug Calibrator/Controls: Contain Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine, and Methadone for calibration/QC of Amphetamine, Barbiturates, Cocaine, and Methadone assays on RX series analysers.

To obtain the detailed study information, you would typically need to consult the full 510(k) submission available through the FDA's substantial equivalence database or directly from the manufacturer, as the provided "Indication for Use" document is only a summary.

Summary

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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 consists of a stylized depiction of a human figure embracing a bird, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Randox Laboratories Ltd. c/o Pauline Armstrong 55 Diamond Road Crumlin, County Antrim BT29 4QY United Kingdom

MAY - 8 2012

K113751 Re:

RT13131 Randox' Multidrug Calibrator Set Randox Multidrug Controls, Level 1 & 2 Regulation Number: 21 CFR §862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Codes: DIO, DLJ, and LAS Dated: March 30, 2012 Received: April 02, 2012

Dear Ms. Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We nave reviewed your Section 510(x) premier is substantially equivalent (for the referenced above and nave atternment and actived predicated predicated in
indications for use stated in the enclosure to the marketed in indications for use stated in the cheosure/ to regars ment date of the Medical Device interstate commerce prior to May 20, 1970, the sideed in accordance with the provisions of
Amendments, or to devices that have been reclassified in accordance approval of a p Amendments, of to devices that have been router approval of approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do not require, systems to the general the Federal Food, Drug, and COSIlienc Act (related the device, subject to the general
approval application (PMA). You may, therefore, market the devices subject to the gener approval application (1 MA). Tou may, increased controls provisions of the Act include controls provisions of the Act. The general of any of devices, good manufacturing practice,
requirements for annual registration, listing of devices on lequirements for annual is against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III
ns affective If your device is classified (see above) into chine major regulations affecting
(PMA), it may be subject to such additional controls. Existing (CFR), Parts 800 to 895 (PMA), it may be subject to Such adultional Concern Concerner (CFR), Partis 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Partis 800 to your device can be found in Title 21, Code of Peacharts (1 - 1) - )
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 Please be advised that FDA s Issuanter of a stuck complies with other requirements
mean that FDA has made a determination odministared by other Federal agencies. mean that FDA has made a delemination mat your and result was and registration of the Act or any Federal statues and tegulations and limited to: registration
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with all the Act Sicquitently more 801 and 809); medical device
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and go and listing (21 CFR Part 807); fabeting (21 CFR rans ovents) (21 CFR 803); and good
reporting (reporting of medical device-related adverse events) (21 CFR 803); and good reporting (reporting of medical device-related adverse overse) (22 =========================================================================================================== CFR Part 820).

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Page 2

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/Medical

Devices/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/Resourcesfor You/Industry/default.htm

Sincerely yours,

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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):

UNKNOWN

Device Name:

COCAINE METABOLITE ASSAY, MULTIDRUG CALIBRATOR SET AND MULTIDRUG CONTROLS LEVEL 1 & 2

Indication for Use:

Randox Cocaine Metabolite Assay

The Randox Laboratories Ltd. Cocaine Assay is an in vitro diagnostic test for the qualitative and semiquantitative detection of Cocaine in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for Benzovlecgonine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Cocaine use or overdose. The Randox Cocaine Metabolite Assay has been developed for use on the RX series analysers, which includes the RX Daytona and the RX Imola.

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 dilution 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 must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Randox Multidrug Calibrator Set

The Randox Multidrug Calibrator Set consists of liquid calibrators containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Cocaine and Methadone assays on the RX series analysers, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

Randox Multidrug Controls, Level 1 & 2

The Randox Multidrug Controls, level 1 and 2 are liquid controls containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Cocaine and Methadone assays on the RX series analysers, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

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)

DSA

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k 113 71

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).