(207 days)
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No
The summary describes a qualitative immunoassay for detecting cannabinoids in urine using a specific analyzer and calibrators. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on the chemical detection method and the required laboratory setting and personnel.
No
The device is described as a test designed to detect cannabinoids in urine for the diagnosis of cannabinoid use or abuse. It does not provide any treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "Qualitative results obtained can be utilised in the diagnosis of cannabinoid use or abuse." This explicitly indicates a diagnostic purpose for the device.
No
The description explicitly states the device is a "test" designed for use "on the evidence® analyser," indicating it is a physical assay kit used with a specific hardware analyzer, not a standalone software product.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the test is designed to "detect cannabinoids in urine" and that the "Qualitative results obtained can be utilised in the diagnosis of cannabinoid use or abuse." This clearly indicates the device is intended for use on biological samples (urine) to provide information for diagnostic purposes.
- Sample Type: The device analyzes urine, which is a biological specimen.
- Purpose: The purpose is to detect a substance (cannabinoids) within the biological sample to aid in diagnosis.
The description of the calibrators also supports this, as calibrators are essential components for ensuring the accuracy and reliability of IVD tests.
N/A
Intended Use / Indications for Use
The evidence®Cannabinoids test has been designed for use only on the evidence® analyser to detect cannabinoids in urine, using a cut-off of 50ng/ml. Qualitative results obtained can be utilised in the diagnosis of cannabinoid use or abuse.
This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS.
The Cannabinoids Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The evidence® Drugs of Abuse Calibrators.
The evidence®Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and 11-nor-D9-THC-9 carboxylic acid.
There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system.
The evidence®Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
LDJ, DKB
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
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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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§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).
0
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 features a stylized eagle or bird-like symbol with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is simple and monochromatic.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV ຂໍ້ 3ໍ້ 2004
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories, Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
Re: K041142
Trade/Device Name: evidence® Cannabinoids Assay and evidence® Drugs of Abuse Calibrators Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DKB Dated: October 26, 2004 Received: October 28, 2004
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,
Sincerely yours,
Cornelia B. Lohs
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):_
| Device Name: | evidence® CANNABINOIDS ASSAY AND
evidence® DRUGS OF ABUSE CALIBRATORS |
| -------------- | -------------------------------------------------------------------------- |
|---|
Indications For Use:
The evidence®Cannabinoids test has been designed for use only on the evidence® analyser to detect cannabinoids in urine, using a cut-off of 50ng/ml. Qualitative results obtained can be utilised in the diagnosis of cannabinoid use or abuse.
This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS.
The Cannabinoids Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The evidence® Drugs of Abuse Calibrators.
The evidence®Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and 11-nor-D9-THC-9 carboxylic acid.
There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system.
The evidence®Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CDRH. Office of In Vitro Diagnostic Devices (OIVD) Concurre
Albert
Division Sign Off
Page 1 of
Office of In Vitro Diagne
510(k) K041192