(67 days)
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)
solid phase enzyme-linked immunosorbent assay(ELISA)
The provided document is a 510(k) clearance letter from the FDA for a device called "UBI MAGIWEL™ Cocaine Metabolites." This type of letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, but it does not typically contain the detailed study data, acceptance criteria, or performance metrics that would describe how the device meets specific performance standards.
The letter explicitly states: "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... You may, therefore, market the device, subject to the general controls provisions of the Act." This means the FDA found the device to be comparable to an existing device, which implies it's expected to perform similarly, but the performance data used to demonstrate this substantial equivalence is usually part of the 510(k) submission itself, not the clearance letter.
Therefore, I cannot extract the requested information from the provided text. The document is an approval letter, not a detailed study report.
To answer your questions, one would need to review the original 510(k) submission (K973156) made by United Biotech, Inc. to the FDA, which would contain the performance data and study details.
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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
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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
§ 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).