(323 days)
The Randox Laboratories Limited Cocaine Metabolite Assay is an in vitro diagnostic test for the qualitative determination of the major metabolite of cocaine, benzovlecgonine (BZG), in human urine. This is a competitive immunoassay. A cut-off of 300ng/ml benzoylecqonine has been established in line with SAMHSA recommendations.
This assay is for use only on the automated Evidence™ Analyser.
Note: This test provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrophotometry (GC/MS) is the preferred confirmatory method.
The Cocaine Metabolite Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Limited Drugs of Abuse Calibrators are liquid calibrators containing benzoylecgonine. There are 9 levels of calibrator.
They have been developed for use in calibration of the Evidence™ system.
These Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Evidence™ is an automated immunoassay analyser with dedicated software. It is for use with the Randox Evidence Cocaine Assay.
Evidence™ is an automated immunoassay analyser with dedicated software. It is for use with the Randox Evidence Cocaine Assay.
The provided text is a 510(k) premarket notification letter from the FDA for a Cocaine Metabolite Assay, Drugs of Abuse Calibrators & Evidence™ Automated Immunoassay Analyzer. This document primarily focuses on the regulatory approval and indications for use, rather than a detailed study report. As such, much of the requested information regarding specific acceptance criteria, study design, and performance metrics is not present in the provided text.
Based on the available information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "A cut-off of 300ng/ml benzoylecqonine has been established in line with SAMHSA recommendations." This is a key acceptance criterion for the qualitative determination of cocaine metabolite. However, the document does not provide a specific table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) from a study against these criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text. The document refers to "Gas Chromatography / Mass Spectrophotometry (GC/MS) as the preferred confirmatory method," which implies a laboratory-based, objective ground truth, rather than expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
5. 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 automated immunoassay analyzer for detecting cocaine metabolites in urine. This is a diagnostic test performed by the machine, not an AI-assisted interpretation by human readers. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This would be the primary mode of operation for an "Automated Immunoassay Analyzer." The document explicitly states the device is "for use only on the automated Evidence™ Analyser" and "Evidence™ is an automated immunoassay analyser with dedicated software." While specific performance metrics for this standalone operation are not detailed in the provided text, the nature of the device implies a standalone performance evaluation would have been conducted as part of its development and FDA submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The preferred confirmatory method for the Cocaine Metabolite Assay is stated as Gas Chromatography / Mass Spectrophotometry (GC/MS). This is an objective, analytical laboratory method, not expert consensus or pathology.
8. The sample size for the training set
This information is not available in the provided text.
9. How the ground truth for the training set was established
This information is not available in the provided text. However, it can be inferred that if a training set were used, its ground truth would also likely be established through GC/MS, consistent with the confirmatory method for the assay.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 3 2003
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
Re: K030360
Trade/Device Name: Cocaine Metabolite Assay, Drugs of Abuse Calibrators & Evidence™ Automated Immunoassay Analyzer Regulation Number: 21 CFR 862.3250
Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO; JJE; DLJ Dated: November 3, 2003 Received: November 5, 2003
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 yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director 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)
K030360
Device Name
COCAINE METABOLITE ASSAY, DRUGS OF ABUSE CALIBRATORS & EVIDENCE™ AUTOMATED IMMUNOASSAY ANALYSER
Indications For Use:
Cocaine Metabolite Assay
The Randox Laboratories Limited Cocaine Metabolite Assay is an in vitro diagnostic test for the qualitative determination of the major metabolite of cocaine, benzovlecgonine (BZG), in human urine. This is a competitive immunoassay. A cut-off of 300ng/ml benzoylecqonine has been established in line with SAMHSA recommendations.
This assay is for use only on the automated Evidence™ Analyser.
Note: This test provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrophotometry (GC/MS) is the preferred confirmatory method.
The Cocaine Metabolite Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Drugs of Abuse Calibrators
The Randox Laboratories Limited Drugs of Abuse Calibrators are liquid calibrators containing benzoylecgonine. There are 9 levels of calibrator.
They have been developed for use in calibration of the Evidence™ system.
These Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Evidence™ Automated Immunoassay Analyser
Evidence™ is an automated immunoassay analyser with dedicated software. It is for use with the Randox Evidence Cocaine Assay.
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Congurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_ (Optional format 1-2-96)
Carol Benern
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_KO3036D
§ 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).