(187 days)
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No
The summary describes a qualitative immunoassay for detecting opiates in urine and associated calibrators. There is no mention of AI or ML in the intended use, device description, or any other section. The analysis is based on a cutoff concentration, which is a standard immunoassay method, not indicative of AI/ML.
No
The device is described as an assay and calibrators for the qualitative detection of opiates, used in diagnosis, not for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Qualitative results obtained can be utilised in the diagnosis and treatment of opiate use or overdose."
No
The device description explicitly mentions "liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and morphine sulphate pentahydrate," which are physical components, not software. The device is an assay and calibrators used with an "evidence® analyser," implying hardware is involved.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for qualitative detection of opiates in urine" and that the results "can be utilised in the diagnosis and treatment of opiate use or overdose." This clearly indicates the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes.
- Device Description: The device is described as an "evidence® Opiates Assay" and includes "evidence® Drugs Of Abuse Calibrators." Assays and calibrators used for testing biological samples are typical components of IVD systems.
- Specimen Type: The device is designed for use with "urine," which is a human biological specimen.
- Purpose: The purpose is to detect the presence of opiates, which is a substance relevant to a person's health status (drug use or overdose).
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety or suitability of a potential recipient, or to monitor therapeutic measures. This device fits this definition.
N/A
Intended Use / Indications for Use
The evidence® Opiates test has been designed for use only on the evidence® analyser for qualitative detection of opiates in urine, using a cutoff concentration of 300ng/ml. Qualitative results obtained can be utilised in the diagnosis and treatment of opiate use or overdose. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The Opiates Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and morphine sulphate pentahydrate. 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
DJG, 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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 3 2004
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
Re: K041144
Trade/Device Name: evidence® Opiates Assay evidence® Drugs Of Abuse Calibrators Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DKB Dated: October 19, 2004 Received: October 25, 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,
Seain M. Cooper, ULS, DVM.
Jean M. Cooper, MS, D.V.M. 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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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________ evidence® DRUGS OF ABUSE CALIBRATORS
Indications For Use:
The evidence® Opiates test has been designed for use only on the evidence® analyser for qualitative detection of opiates in urine, using a cutoff concentration of 300ng/ml. Qualitative results obtained can be utilised in the diagnosis and treatment of opiate use or overdose.
This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS.
The Opiates 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 morphine sulphate pentahydrate. 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)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Siaff-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of _ 1
510(k) K041144