DRUGS OF ABUSE MULTI-TEST STRIP

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around the edge. Inside the circle is an abstract image of an eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 25 2001 Ms. June Shozi Senior Scientist Microdiagnostics, Inc. 28062 Forbes Road - Suite B Laguna Niguel, CA 92677 > k011952 Trade/Device Name: Multi-Test Strip Regulation Number: 21 CFR 862.3100; 21 CFR 862.3250; 21 CFR 862.3870; 21 CFR 862.3650 Regulation Name: Amphetamine test system; Cocaine and cocaine metabolite test system; Cannabinoid test system; Opiate test system Regulatory Class: Class II; Class II; Class II; Class II Product Code: DKZ; DIO; LDJ; DJG; LCM Dated: August 20, 2001 Received: August 23, 2001 Dear Ms. Shozi: Re: 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2 - 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 needicate 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 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}------------------------------------------------ 1011952/191 Page_1_of_1 து அருக்கு 510(k) Number (if known): K011952 Device Name: Drugs of Abuse Multi-Test strip ## Indications For Usc: The Microdiagnostics, Inc. D&V The Microdiagnostics, Inc. Distincts the metabolit The Microdiagnostics, Inc. barge of detects the metabolites is an immunoassay that quartiallery oceates and Phencyclidine of Amphecamine, Gocaine, Massystems in human urine at the SAMHSA cutoff levels. This test is intended for professional use only. Kan Cooper (Division Sign-Off) Division of Clinical Laboratory Device: 510(k) Number K011952 SK-43 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBIED) 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)