MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUL 2 2003 2 2003 Dr. Raphael Wong President Branan Medical Corporation 10015 Muirlands Road - Suite E Irvine, CA 92618 Re: k030113 Trade/Device Name: Monitect® Oxycodone Drug Screen Cassette Test Fastect 110 Oxycodone Drug Screen Dipstick Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: May 8, 2003 Received: May 20, 2003 Dear Dr. Wong: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {1}------------------------------------------------ ## Page 2 - This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Steven Putman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ KO3643 510(k) Number (if known): Monitect® Oxycodone Drug Screen Cassette Test Device Name: Fastect™ Oxycodone Drug Screen Dipstick Test Indications For Use: The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are in vitro screening test devices for the rapid detection of Oxycodone in human urine. The tests are standardized to detect Oxycodone at a cut-off concentration of 100 ng/mL. The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are used to obtain visual, qualitative The assays provide only preliminary results. Clinical consideration and results. professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method. The devices are intended for professional in vitro diagnostic use only. They are not intended for over-the-counter sale to lay users. Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K030113 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|-----------------------------------------------------| | Prescription Use<br>(Per 21 CFR 801.109) | <div> <span style="font-size: 2em;">✓</span> </div> | | OR | | | Over-The-Counter Use<br>(Optional Format 1-2-96) | |