UBI MAGIWEL AMPHETAMINE METABOLITES

K973153 · United Biotech, Inc. · DJG · Oct 28, 1997 · Clinical Toxicology

Device Facts

• Record ID: K973153
• Device Name: UBI MAGIWEL AMPHETAMINE METABOLITES
• Applicant: United Biotech, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Oct 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

THE UBI MAGIWEL™ Amphetamine metabolites is a solid phase enzyme-linked immonosorbent assay(ELISA). This test provides a specific and sensitive assay to qualitatively detect the major amphetamine metabolites in human urine.

Device Story

UBI MAGIWEL™ Amphetamine Metabolites is a solid-phase enzyme-linked immunosorbent assay (ELISA) for qualitative detection of amphetamine metabolites in human urine. Used in clinical laboratory settings by trained personnel. Input: human urine sample. Principle: competitive binding immunoassay where metabolites in sample compete with enzyme-labeled drug for antibody binding sites on solid phase. Output: colorimetric signal proportional to drug concentration, interpreted by healthcare provider to determine presence of amphetamine metabolites. Assists in clinical assessment of drug use.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics typical of ELISA-based drug screening assays.

Technological Characteristics

Solid-phase enzyme-linked immunosorbent assay (ELISA). Utilizes antibody-antigen binding principle. Qualitative colorimetric detection.

Indications for Use

Indicated for the qualitative detection of major amphetamine metabolites in human urine samples.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 8 1997

Wuan T. Lu Director United Biotech, Inc. 110 Pioneer Way #C Mountain View, California 94041-1517

Re : K973153 UBI MAGIWEL™ Amphetamine Metabolites Regulatory Class: II Product Code: DJG 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 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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510(k) Number (if known):_K973153

Device Name: AMPHETAMINE METAROLITES

Indications For Use:

THE UBI MAGIWEL™ Amphetamine metabolites is a solid phase enzyme-linked immonosorbent assay(ELISA). This test provides a specific and sensitive assay to qualitatively detect the major amphetamine metabolites in human urine.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory De
510(k) Number. Laboral Being 153