TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC - 3 1997 John F. Bruni, Ph.D. . Director, Clinical and Regulatory Affairs Biosite Diagnostics 11030 Roselle Street San Diego, California 92121 K973784 Re : Triage® Panel for Drugs of Abuse plus Trycyclic Antidepressants and Opiates 2000 Regulatory Class: II Product Code: DKZ, DIS, JXM, DIO, DJR, DJG, LFG, LCM October 1, 1997 Dated: October 3, 1997 Received: Dear Dr. Bruni: 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. 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 regulations. {1}------------------------------------------------ Page 2 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 Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to 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 {2}------------------------------------------------ 1-11 1 S 10(k) Number if known) 97 3724 Device Names: Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants - Opiates 2000 - 8 test panel Triage Panel for Drugs of Abuse -- Opiates 2000 - 7 test Panel ITriage | Lance for Drugs of Abuse plus Methadone – Opiates 2000 – Methadone substituted for PCP Triage 8 Panel for Drugs of Abuse - Opiates 2000 - Methadone substituted for PCP Triage Intervention Panel for Drugs of Abuse - Opiates 2000 - 5 test panel Triage Panel for Drugs of Abuse plus Tricyclic Antidepressants -8 test panel Triage Panel for Drugs of Abuse - 7 test Panel Triage Panel for Drugs of Abuse plus Methadone - Methadone substituted for PCP 8 Panel for Drugs of Abuse - Methadone substituted for PCP Triage T Triage Intervention Panel for Drugs of Abuse - 5 test panel The above products have the screening cut-off concentrations s outlined below: Indications for Use: The Triage® Panel for Drugs of Abuse plus Trycyclic Antidepressants - Oplates 2000 (and other forms of the product ) The mage Faller of Drugs of Audie plus Tryoyano of the major metabolites of drugs of also Phencyclidine, Benzodiazepines, Cocain Metabolite, Amphetamines, THC, Opiates, Barbiturates, and Tricyclic Antideoressants in urine, The cut off concentrations are provided below: (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number 673784 MTD Methadone 300 no/mL РСР Phencyclidine 25 na/mL* BZO Benzodiazepines 300 ng/mL 300 ng/mL COC Cocaine (Benzoylecgonine) 1000 ng/mL* AMP Amphetamines 50 ng/mL THC THC(11-nor42-THC-9-carboxylic acid) 2000 ng/mL (300 ng/mL-other test formats) OPI Opiates (Morphine) 300 ng/mL BAR Barbiturates TCA Tricyclic Antidepressants 1000 ng/mL This test provides only a preliminary test result. A more specific atternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatographylmass spectrometry (GCMS) is the preferred Clinical consideration and Other chemical confirmation methods are available. confirmatory method. professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The tricyclic test is a qualitative screening test. A negative result does not ellminate the possibility of the presence of tricyclic antidepressants in the urine specimen at concentrations lower than 1000 ng/ml. Should confirmation of the test result for the parent compound or the metabolites be desired, an alternative method that is capable of identification and quantification should be used, e.g. HPLC, GC or GC/MS. A positive screening result may be due to the reactivity of the parent tricyclic antidepressant and the various metabolites of the respective compound. * Recommended Screening cut of concentrations by the Substance Abuse and Mental Health Services Administration formerly the National Institute on Drug Abuse. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The Counter Use (Optional Format 1-2-96)