(67 days)
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No
The summary describes a standard ELISA test kit, which is a biochemical assay and does not involve AI or ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is an in vitro diagnostic test for detecting cocaine metabolites in human urine, which is used for diagnostic purposes, not for treating a disease or condition.
Yes
The device is an enzyme-linked immunosorbent assay (ELISA) test kit designed to detect Cocaine metabolites in human urine, which is a diagnostic function to identify the presence of specific substances.
No
The device description explicitly states it is a "solid phase enzyme-linked immunosorbent assay (ELISA)", which is a laboratory test kit involving physical reagents and components, not software alone.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "solid phase enzyme-linked immunosorbent assay (ELISA)" for the "miked innifullosorbent of Cocaine metabolites in human urine." This describes a test performed in vitro (outside the body) on a biological sample (human urine) to detect a specific substance (Cocaine metabolites) for diagnostic purposes (presumably to determine the presence of cocaine use).
- Device Description: The description "solid phase enzyme-linked immunosorbent assay (ELISA)" further confirms it's a laboratory-based test method.
- Anatomical Site: "human urine" is a biological sample commonly used for in vitro diagnostic testing.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description by testing a biological sample to detect a substance related to a condition (cocaine use).
N/A
Intended Use / Indications for Use
The UBI MAGIWEL™ Cocaine metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides miked innifullosorbent of Cocaine metabolites in human urine. (for Professional use only)
Product codes
DJG
Device Description
The UBI MAGIWEL™ Cocaine metabolites is a solid phase enzymelinked immunosorbent assay(ELISA).
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
Professional use only
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)
Not Found
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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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Wuan T. Lu · Director United Biotech, Inc. 110 Pioneer Way #C Mountain View, California 94041-1517
OCT 28 1997
Re : K973156 UBI MAGIWEL™ Cocaine Metabolites Requlatory Class: II Product Code: DJG Dated: Auqust 19, 1997 Received: Auqust 22, 1997
Dear Wuan T. Lu:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. - Also, please note ----the regulation entitled, "Misbranding by reference to premarket notification™ (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
VIII 510(K)Number(if Known):
Device Name: Cocaine metabolites
Indications for Use:
The UBI MAGIWEL™ Cocaine metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides miked innifullosorbent of Cocaine metabolites in human urine. (for Professional use only)
(Division Sign-Off)
Division of Clinical Laborator F
aboratogh156
510(k) Number