(67 days)
Not Found
Not Found
No
The summary describes a standard ELISA test kit for detecting opiate metabolites in urine, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is an in vitro diagnostic test used to measure opiate metabolites in human urine, not to treat a condition.
Yes
The device is described as an "ELISA" that provides "qualitative measurement of Opiate metabolites in human urine," which is a diagnostic function to detect the presence of substances in a biological sample.
No
The device is described as a solid phase enzyme-linked immunosorbent assay (ELISA) test kit, which is a laboratory-based chemical assay and involves physical components, not just 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 Opiate metabolites in human urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro) to gain information about a person's health status (presence of opiate metabolites).
- 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 body for analysis.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UBI MAGIWEL™ Opiate metabolites is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Opiate metabolites in human urine. (for Professional use only)
Product codes
DJG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 : K973155 UBI MAGIWEL™ Opiates Metabolites Requlatory Class: II DJG Product Code: Dated: August 19, 1997 Received: August 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 marke is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beated in the 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. ਰ 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 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 requlation may result in requlatory 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 regulations.
1
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CHIA-60), this device may requiries if it does, you should contact Cacegorization: "Io ass Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as Inib recei will assock) premarket notification. The FDA descriped in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets promos, 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 the regulation chercroad, "ALER 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: Opiate metabolites
Indications for Use:
The UBI MAGIWEL™ Opiate metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Opiate metabolites in human urine. (for Professional use only)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K973155
$\mathscr{g}$