(323 days)
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No
The document describes a standard automated immunoassay analyzer and assay kit. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The analysis is based on a competitive immunoassay and a fixed cut-off value.
No
The device is described as an "in vitro diagnostic test" and an "automated immunoassay analyser" for detecting a cocaine metabolite in human urine, which is for diagnostic purposes, not therapeutic.
Yes
The "Randox Laboratories Limited Cocaine Metabolite Assay" is explicitly stated as "an in vitro diagnostic test." The Evidence™ Analyser is used with this diagnostic assay.
No
The device description explicitly states "Evidence™ is an automated immunoassay analyser with dedicated software." This indicates the device includes hardware (the analyser) in addition to software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Randox Laboratories Limited Cocaine Metabolite Assay is an in vitro diagnostic test.
- Sample Type: The test is performed on human urine, which is a biological sample taken from the body.
- Purpose: The test is used for the qualitative determination of a substance (benzoylecgonine) in that sample to provide information about a person's health status (in this case, potential cocaine use).
- Setting: The test is intended for use by suitably qualified laboratory personnel under appropriate laboratory conditions, which is a typical setting for IVD tests.
The description of the calibrators and the Evidence™ analyser also support this, as they are components used in conjunction with the IVD assay.
N/A
Intended Use / 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.
Product codes
DIO; JJE; DLJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
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Intended User / Care Setting
suitably qualified laboratory personnel under appropriate laboratory conditions.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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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Page 2 -
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
2
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