(334 days)
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No
The summary describes a standard ELISA test kit, which is a biochemical assay and does not typically involve AI/ML. There are no mentions of AI, ML, or related concepts like image processing or training/test sets.
No
This device is an in vitro diagnostic test for qualitative measurement of Marijuana metabolites in human urine, not a therapeutic device.
Yes
The device is a diagnostic device because its intended use is to provide qualitative measurement of Marijuana metabolites in human urine, which is a diagnostic test.
No
The device is described as a solid phase enzyme-linked immunosorbent assay (ELISA) test kit, which is a laboratory-based assay involving physical reagents and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative measurement of Marijuana metabolites in human urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro).
- Device Description: It's described as a "solid phase enzyme-linked immunosorbent assay (ELISA)," which is a common laboratory technique used for in vitro diagnostic testing.
- Anatomical Site: The sample is "human urine," which is a biological specimen collected from the human body for analysis.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The UBI MAGIWEL™ Marijuana metabolites is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Marijuana metabolites in human urine. (for Professional use only)
Product codes
LDJ
Device Description
The UBI MAGIWEL™ Marijuana metabolites is a solid phase enzyme-linked 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
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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)
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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).
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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Jul 2 2 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Wuan T. Lu Director United Biotech, Inc. 110 Pioneer Way, #C Mountain View, CA 94041-1517
Re : K973154 Trade Name: UBI MAGIWEL Marijuana Metabolites Regulatory Class: II Product Code: LDJ Dated: June 12, 1998 June 16, 1998 Received:
Dear Mr. 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, Druq, and Cosmetic Act (Act). 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 reqistration, 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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (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 action. In addition, FDA may publish further announcements 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 Regulations.
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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 regulation (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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
stiven Autman
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):
9731,54
Device Name: Marijuana metabolites
Indications for Use:
The UBI MAGIWEL™ Marijuana metabolites is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Marijuana metabolites in human urine. (for Professional use only)
/Prescription Use
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 983154