AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three heads. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 2 9 2004 John Wu, Ph.D. Director of Quality Assurance Ameditech Inc. 10340 Camino Sante Fe Suite F San Diego, CA 92121 Re: k042975 . Trade/Device Name: Ameditech ImmuTest Multi-Drug Screen Panel II Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS, JXM, DJR, LAF, DJG Dated: October 26, 2004 Received: October 28, 2004 Dear Dr. Wu: 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) I mis lotter will and my you to 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 (240)276-0484. 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/industry/support/index.html Sincerely yours, acting Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): k 042975 ## Device Name: Ameditech ImmuTest Multi-Drug Screen Panel II Indications For Use: The Ameditech ImmuTest Multi-Drug Screen Panel II is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows. | Test | Calibrator | Cutoff<br>(ng/ml) | |--------------------------------------------|----------------------------------|-------------------| | Barbiturates (BAR) | Secobarbital | 300 | | Benzodiazepines (BZO) | Oxazepam | 300 | | 3,4methylenedioxymethamphetamine<br>(MDMA) | 3,4methylenedioxymethamphetamine | 500 | | Methamphetamine (MET1000) | d-Methamphetamine | 1000 | | Methadone (MTD) | Methadone | 300 | | Opiates (OPI300) | Morphine | 300 | | Oxycodone (OXY) | Oxycodone | 100 | This test has three types of test format: card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use. This assay provides only a preliminary result. Clinical consideration and 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 confirmation method. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) > Office of In Vitro Diagnostic Devices (OIVD) Concurrence of Division Sign-Off Office of In Vitro Diagnostic Device Evaluatio Page 1 of 1