LIVESURE AMPHETAMINE SCREEN TEST

{0}------------------------------------------------ K011609 ### SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS The sponsor, Pan Probe Biotech, Inc., has developed, manufactured, and tested under Good Laboratory Practices quidelines, an in vitro diagnostic device for the qualitative testing of urine samples for the presence of Amphetamine , its analogs or metabolites in a screening format. The trade names of these devices are the Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip, having a designated common name of Amphetamine Test Systems and classification as Class II devices as per listing 21 CFR 862.3100. These devices are intended for medical/forensic screening of urines for Amphetamine. The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip (i.e., LiveSure™ Amphetamine Tests) are rapid qualitative chromatographic immunoassays in which a chemically labeled drug conjugate competes with Amphetamine (AMP) drug, analogs or metabolites that may be present in test urinary samples for limited specific antibody binding sites. LiveSure™ Amphetamine devices contain a unique membrane that has been pre-coated both with AMP drug conjugate at the test band, and have a built-in reference band with second antibody as a system control band. A pink colored anti-AMP monoclonal antibody-colloidal gold conjugate pad is placed on the test strip. In the absence of AMP drug, analogs or metabolites in the test urine, the pink colored antibody-colloidal gold conjugate moves chromatographically along with the unnary sample on the capillary action. The antibody-colloidal gold conjugate binds to drug conjugate, forming an antibody-antigen complex. This complex binds to drug conjugate as a captured reagent at the test region and produces a visible pink colored band. When AMP is present in a test urine, that drug, analog or metabolite antigen competes with AMP conjugate at the test band region for the limited antibody sites on the antibody-colloidal gold conjugate. When a sufficient concentration of urinary AMP drug, analogs or metabolites is present, it blocks limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate to the Amphetamine drug conjugate zone located at the LiveSure™ Amphetamine test band region. To serve as a procedural control, a pink colored band in a control region will always appear regardless of presence of AMP in samples. Thus, negative urine samples produces two pink colored bands, while positive urine samples produce only one pink colored band. In-house testing of LiveSure™ Amphetamine Screen 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 257 urine samples against LiveSure™ Amphetamine 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™ Amphetamine Test Card or Strip gave both 98.8% agreement with GC/MS negative results, whereas EMIT II® yielded only a 97.6% correlation with GC/MS negatives. In comparing the Test Card and Test Strip positives with EMIT® II positives, both 98.0% respective agreement with EMIT® II was found. Specificity of Test Card and Test Strip negatives with EMIT® II negatives was shown to be 100% 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 Amphetamine, however, the LiveSure™ Amphetamine Screen Test Card and Strip yielded no false positives or FP, but EMIT® II resulted in 1 FP values for urine samples with GC/MS results below 750 ng/ml of Amphetamine. Finally, the LiveSure™ Amphetamine Test Card and the Test Strip gave overall accuracy results of 255/257 (99.2%), respectively, versus GC/MS data, whereas 253/255 (98.4%) accuracy was obtained with EMIT®II. Thus, as judged against GCMS results from an independent laboratory, the LiveSure™ Amphetamine 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 Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in a simple, flowing line drawing. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. Public Health Service 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 510(k) Number: K011609 Re: 510(K) Number. RUT1007 Trade/Device Name: Pan Probe Biotech LiveSure™ Amphetamine Screen Tests Regulation Number: 862.3100 Regulatory Class: II Product Code: DKZ 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 in we have reviewed your Section 910(t). It is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to devices that have been reclassified in accordance with the provisions of the skeries, subject to Amendments, or to devices mat liave book rockessince your recefere, market the device, subject to Federal Food, Drug, and Cosmono Act. The general controls provisions of the Actinelude the general controls provisions of the Fict. "The gollering practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III If your device is classifica (sec above) into such additional controls. Existing major regulations (Premarket Approval), it may of subject to sueral Regulations, Title 21, Parts 800 to 895. affecting your device can be found in the Code of Federal Regulations, Title 21, Ma allecting your device can be round in the essumes compliance with the Good Manufacturing A substantially equivalient acterimidator assumments (21 CFR Part 820) and that, through Practice for Mcdical Devioles: "Sensial (Drug Administration (FDA) will verify such periodic Olvir inspections, the I ood alla Dring regulation may result in regulatory action. In the closed assumptions. Transic to compty was and seeming your device in the Federal addition, FDA may publish furtion anno anno are market notification submission does not affect Register. Flease note: this responder sections 531 through 542 of the Act for devices under the ally obligation you inight have andel 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) prematket This letter will allow you to begin marketing your device to a legally marketed notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantal equivalence of 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 device devices), please contact the Office of Compliance at additionally 809.10 for in vitro diagnostic devices), please contact the Of additionally 809.10 for in yife diagnostic as nothe promotion advertising of your device, (301) 594-4588. Additionally, for questions on the promotion advertising of your de (301) 594-4588. Additionally, for questions on and promoted. A hiso, please note the regulation please contact the Office of Compliance at (30) - 1101 (CFR 807.97). Other general entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other genera entitled, "Misbranding by reference oplemans. Included from the Division of Small information on your responsibilities under the Act may be obtained from the Division of Smal information on your responsibilities under (800) 638-2041 or (301) 443-6597 or at its Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at Manufacturers Assistance at its ton-free nation (or the ) internet address "http://www.fda.gov/cdrh/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 Office of Devices and Radiological Health Enclosure {3}------------------------------------------------ ### 510(k) Number (if known): K011609 # 5 f0(k) Namber (if mire - Pan Probe Biotech LiveSure™ Amphetamine Screen Tests ## INDICATIONS FOR USE STATEMENT: INDICATIONS FOR USE ON And Test Card and Test Card and Test Strip devices are The Pan Probe Biotech LiveSure™ Amphetamine Screen Town immuno-chroman The Pan Probe Biotech LiveSure" Amphetamine Screen Test Card and Parine urinary rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromative urinary rapid in vitro diagnostic (IVD) qualifative lateral nov innune at the NID &(National linstitute assays for detection of D-Amphetamine (AMP) in human urine at the NICA (Nation assays for detection of D-Amphetamine (AMP) in numan unte at the Rich (microsis in the mineralian) cuton Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services and SAMHSA (Substance Abuse and Mehilar inealir ocliniose Non Roman, Marina, Inc. off level of 1000 ng AMP/ml. These tests are intended for visual, qualitative (VD screening, off level of 1000 g AMP/ml. These test are intended for quantialive results, nor for over the counter and professional use only, and are not intended for quantalites provide only pliminary qualitative These screen tests for Amphetamine, analogs and method must be used in order to These screen tests for Amphetanine, analogs and metabol must be used in order to obtain a analytical data. A more specific quantitative alternative method must be used in ord analytical data. A more specific quantitative niemod intost or chromatographic mass confirmed analytical result NIDA and SAMHSA confirmed analytical result. NIDA and SAMHSA method. Clinical Considerations and spectrometry (GCMS) as the preferred committed onlined belined believe test result, particularly when professional judgment should be applied to any drug of abuse test result professional Judge results are indicated. ## (Please do not WRITE BELOW THIS LINE - CONTINUE on another Page if NEEDED] ## Concurrence of CDRH, Office of Device Evaluation (ODE) L (Division Sign-Off) Division of Clinical Laboratory Devices K011609 510(k) Number. Prescription Use: (Per 21 CFR 801.109) or Over-the-Counter Use: (Optional Format 1-2-96)