RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC

{0}------------------------------------------------ # March 30th, 2005 SECTION II 510(k) SUMMARY APR 2 4 2006 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. #### 052520 510{k) Number: #### Submitter: Tianjin New Bay Bioresearch Co., Ltd. #3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516 ### Contact Person: Rodrigo Berlie New Product Development Director Telephone: (760) 602-2929 Facsimile: (760) 602-2999 #### Preparation Date: May 30, 2005 # Device Information: Device Classification Name: Immunoassay, Amphetamine, Methamphetamine, Benzoylecgonine, 11-nor-A-9-THC-9-COOH , Morphine, Phencyclidine. Common/Usual Name: Immunoassay Test System for detection of Multiple Drug (up to 6) Screen Test Device in Human Urine Proprietary Name: Rapid Forsure One Step Multiple Drug ( up tp 6 ) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, THC, Morphine and Phencyclifice Test Regulation Number: 21 CFR§862.3650 Regulatory Name: Amphetamine, Methamphetamine, Benzoylecgonine, THC Morphine and Phencyclidine test system Product Code: DJG Regulatory Class: Class II {1}------------------------------------------------ #### Predicate Devices: Rapid One Step Strip Buprenorphine Test is substantially equivalent to Monitect Multiple Drug Screen MOR2000/MET/THC/COC/PCP of Branan Medical Corporation, cleared by FDA( K004034), and GC/MS for its stated intended use. #### Device Description: New Bay For Sure One Step single and Multiple Drug Screen Test card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibodyantigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine 25 ng/ml of Phencyclidine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region . There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred. #### Intended Use: The Forsure One step single and Multiple Drug screen Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine and Phencyclidine Cassette Test are a Chromatographic immunoassay for qualitative determination of the presence of Amphetamine at a cutoff concentration of 1000 ng/ml, Methamphetamine at a cutoff concentration of 1000 ng/ml, THC at a cutoff concentration of 50 ng/ml, Morphine at a cutoff concentration of 2000 ng/ml, Benzoylecgonine at a cutoff concentration of 300 ng/ml , Phencyclidine at a cutoff concentration of 25 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine and Phencyclidine in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatogrphy/mass spectrometry (GC/MS) is the preferred confirmatory method. {2}------------------------------------------------ # Comparison to Predicate Device(s): Forsure Multiple Rapid One Step Drug Screen Test is substantially equivalent to Branan's Monitect Drug Screen Cassette Test system cleared by FDA, e.g., the Brana's Monitect Assay (004034 )and GC/MS for its stated intended use. | Device Characteristics | Subject Device | Predicate Devicce(s) | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Forsure Multiple Drug Screen one<br>step Immunochromatographic<br>Qualitative test.<br>The assay provides a simple and<br>rapid analytical screening<br>procedure to detect up to six<br>different abuse drug<br>(Amphetamine,Methamphetamine,<br>Benzoylegconine, THC,<br>Morphine,and Phencyclidine) in<br>human urine | Monitect Drug Screen<br>Cassette Assay ( K004034)<br>and GC/MS<br>Monitect Multiple Drug<br>Screen<br>immunochromatographic<br>assay for qualitative<br>determination of the<br>presence of up to five<br>different drug<br>(Amphetamine,<br>Methamphetamine, THC,<br>Benzoylecgonine,<br>Phencyclidine in human<br>urine. | | Analyte<br>Cutoff | Amp,Mamp,BEG,THC,MOR,PCP<br>Amp;1000 ng/ml,<br>Mamp:1000 ng/ml,<br>BEG :300 ng/ml,<br>THC: 50 ng/ml.<br>MOR; 2000 ng/ml.<br>PCP :25 ng/ml. | AMP,Mamp,BEG,THC,PCP<br>Amp: 1000 ng/ml,<br>Mamp;1000ng/ml<br>BEG; 300 ng/ml<br>THC ; 50 ng/ml<br>PCP ; 25 ng/ml | | Matrix | Urine | Urine | | Calibrator | None | None | | Instrument | None, Visual read single use | None, Visual Read single<br>use | | Calibration of Reagent | None | None | | Storage | Below 28 °C until expiration | 15°C - 30°C until expiration<br>date | # Summary: The information provided in this pre-market notification demonstrates that Forsure Rapid One Step Multiple up to six Drug Screen Test Device is substantially equivalent to Branan's Monitect Drug Screen Cassette Test system and GC/MS. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supplied in this pre-market notification provides reasonable assurance that the Forsure Multiple Rapid One Step Drug Screen Test is safe and effective for its stated interded use. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized emblem with three curved lines, resembling a person embracing another. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged in a circular fashion. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Tianjin New Bay Bioresearch Co., Ltd. c/o Mr. Rodrigo Berlic New Product Development Director Aventir Biotech, LLC. 3108 Avenida Olmeda Carlsbad, CA 92009 APR 2 4 2006 Re: k052520 Trade/Device Name: Forsure One Step Multiple (Up to Six) Drug Screen Test Card for Amphetamine, Methamphetamine, Bezoylecgonine, 11-nor-A-9 Tetrahydrocannabinal-9-carboxylic acid, Morphine and Phencyclidine. Regulation Number: 21 CFR8862.3100 Regulation Namc: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DJC, DJC, DPK, LDJ, LCM Dated: April 18, 2006 Received: April 19, 2006 Dear Mr. Berlie: 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). {4}------------------------------------------------ Page 2 -- This letter will allow you to begin marketing your device as described in your Section 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 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, Alberto Guti Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): k052520 Device Name: Forsure One Step Multiple (Up to Six) Drug Screen Test Card for Amphetamine, Methamphetamine, Bezoylecgonine, 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid, Morphine and Phencyclidine. # Indications for Use: Forsure One Step Multiple (Up to Six) Drug Screen Test Card is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Bezovlecgonine (BEG/COC), 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid (THC), Morphine (MOR/OPI) and Phencyclidine (PCP) in human urine at cut off concentrations of AMP 1000 ng/ml, MET 1000 ng/ml, BEG 300 ng/ml, THC 50ng/ml, MOR 2000 ng/ml and PCP 25ng/ml. The device may include as few as one and as many as six individual assays. For In Vitro Diagnostic Use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) C.C. Sign-Off Diagnostic Evaluation and Safety K052520 Page 1 of 1