LIVESURE METHAMPHETAMINE SCREEN TESTS

{0}------------------------------------------------ K011610 JUN - 8 2001 ### SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS The sponsor, Pan Probe Biotech, Inc., has developed, manufactured, and tested under GMP guidelines, an in vitro diagnostic device for the qualitative testing of une samples for the presence of Methamphetamine, its analogs or metabolites in a screening format. The trade names of these devices are the Pan Probe Biotech LiveSure™ Methamphetamine Screen Test Card and Test Strip, having a designated common name of Methamphetamine Test Systems and classification as Class II devices as per listing 21 CFR 862.3610. These devices are intended for medical/forensic screening of urines for Methamphetamine. The Pan Probe Biotech LiveSure™ Methamphetamine Screen Test and Test Strip (i.e., LiveSure™ Methamphetamine) are rapid qualitative competitive chromatographic immunoassays in which a chemically labeled drug conjugate competes with Methamphetamine drug, analogs or metabolites that may be present in test urinary samples for limited specific antibody binding sites. LiveSure™ Methamphetamine devices contain a unique membrane that has been pre-coated both with Methamphetamine drug conjugate at the test band, and have a builtin reference band with second antibody as a system control band. A pink colored anti-Methamphetamine monoclonal antibody-colloidal gold conjugate pad is placed on the right side of the test strip. In the absence of Methamphetamine drug, analogs or metabolites in the pink colored antibody-colloidal gold conjugate moves chromatographically along with the urinary sample on the capillary action. The antibodycolloidal gold conjugate binds to drug conjugate, forming an antibody-antigen complex binds to drug conjugate as a captured reagent at the test region and produces a visible pink colored band. When Methamphetamine is present in a test urine, that drug, analog or metabolite antigen competes with Methamphetamine conjugate at the test band region for the limited antibody sites on the antibody-colloidal gold conjugate. When a sufficient concentration of unnary Methamphetamine drug is present, it blocks limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate to the Methamphetamine drug conjugate zone located at the LiveSure™ Methamphetamine test band region. To serve as a procedural control, a pink colored band in a control region will always appear regardless of presence of Methamphetamine in samples. Thus, negative unne samples produces two pink colored bands, while positive urine samples produce only one pink colored band. In-house testing of LiveSure™ Methamphetamine Screen Test Card and Test Strip devices against EMIT® II Assay as a predicate provided data essentially showing equivalency between these devices and the predicate EMIT® II Assay. Additionally, independent clinical testing of 300 urine samples against LiveSure™ Methamphetamine Screen Test Card and Test Strip devices, as well as EMIT® II Assay at an external reference laboratory resulted in a 100% percent agreement with all GC/MS quantitative positive results. Moreover, LiveSure™ Methamphetamine Test Card gave a 98.2 agreement and the Test Strip gave a 97.0% agreement with GC/MS negative results. whereas EMIT II® yielded only a 96.4% correlation with GC/MS negatives. In comparing the Test Card and Test Strip positives with EMIT® II positives, a 97.8% and a 99.3% respective agreement with EMIT® II was found. Specificity of Test Card and Test Strip negatives with EMIT® II negatives was shown to be 98.2% of both. In terms of overall accuracy of values at and below the ±25% range of the NIDA/SAMHSA cut-off of 1000 ng/ml of Methamphetamine, however, the LiveSure™ Methamphetamine Screen Test Card and Strip yielded no false positives or false negative, but EMIT® II resulted in 1 false positives values for urine samples with GC/MS results below 750 ng/ml of Methamphetamine, and 3 false negative values for urine samples with GC/MS results above 1001 ng/ml of Methamphetamine. Finally, the LiveSure™ Methamphetamine Test Card and the Test Strip gave overall accuracy results of 297/300 (99.0%) and 295/300 (98.3%), respectively, versus GC/MS data, whereas 291/300 (97.0%) accuracy was obtained with EMIT®II. Thus, as judged against GC/MS results from an independent laboratory, the LiveSure™ Methamphetamine Test Card and Test Strip were determined to be equivalent in performance to each other and somewhat superior in capability versus assays with EMIT®II. Additional information on this submission may be obtained by contacting Alice Yu, Vice President, Pan Probe Biotech, Inc. at: 858-689-9936 - or by fax at 858-689-6896. {1}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head with three curved lines extending upwards, representing the department's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle symbol. JUN - 8 2001 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 James M. Barquest, Ph. D. Acting Chief Pan Probe Biotech, Inc. c/o California Department of Health Food & Drug Branch P.O. Box 942732 (MS-357) Sacramento, CA 94234 Re: 510(k) Number: K011610 STo(K) Name: Pan Probe Biotech LiveSure™ Methamphetamine Screen Tests Regulation Number: 862.3610 Regulatory Class: II Product Code: LAF Dated: May 21, 2001 Received: May 25, 2001 Dear Dr. Barquest: 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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 (1 commiser rippt of the found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such periodio CHIP mith the GMP regulation may result in regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I Driving protize to your premarket notification submission submission does not affect reason. Flease now might have under sections 531 through 542 of the Act for devices under the any obtigation your and and and provisions, or other Federal laws or regulations. {2}------------------------------------------------ Page 2 This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will allow you to begill marketing your device to a legally marketed notification. The FDA finding of substantial equivalence of your device your douges to notification. The FDA inding of substantial equivalise or , . 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 CFF Part 801 and If you desire specific advice for your do need on our more of the Office of Compliance at additionally 809.10 for in Vitto diagnotions on the promotion and advertising of your device, (301) 594-4588. Additionally, for questions on are p-4639. Also, please note the regulation please contact the Office of Compliance at (301) 594-4639. And agon and Office entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Misoranding by relection to premier Act may be obtained from the Division of Small information on your responsibilities under the Act 12011 112 (607) web it information on your responsibilities and its toll-free number (800) 638-2041 or (301) 443-6597 or at its Manufacturers 7135fbailos av a fda.gov/odrh/dsma/dsmamain.html". Sincerely yours, Steven Sutman 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 {3}------------------------------------------------ # 510(k) Number (if known): K011610 # Device Name: Pan Probe Biotech LiveSure™ Methamphetamine Screen Tests # INDICATIONS FOR USE STATEMENT: The Pan Probe Biotech LiveSure™ Methamphetamine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for viro "diagnolio" (NET) qualifactor "Allin human urine at the at the NiDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 1,000 ng MET/ml. These tests are intended for visual, qualitative IVD screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. These screen tests for Methamphetamine, mendou for qualifikative rocality preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ### Concurrence of CDRH, Office of Device Evaluation (ODE) Fred Lacy (Division Sign-Off) Division of Clinical Laboratory Devices K011610 510(k) Number _ Prescription Use: (Per 21 CFR 801.109) or Over-the-Counter Use: (Optional Format 1-2-96)