FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST

{0}------------------------------------------------ K061617 #### SECTION II 510(k) SUMMARY NOV 2 2 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. 510{k} Number: Designed K #: k061617 ### 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) 822-6517 Facsimile: (760) 602-2999 #### Preparation Date: May 18, 2006 ## Device Information: Device Classification Name: Immunoassay of Amphetamine, Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine, Benzodiazepine, Barbiturates, Marijuana. Methadone , Oxycodone , Tricyclic Antidepressants and Propoxyphene. Common/Usual Name: Immunoassay Test System for Detection of Single and Multiple Dip & Read Abuse Drug Screen Test Device in Human Urine. Proprietary Name: Forsure One Step Dip & Read Drug Screen Test for Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone , Oxycodone, Tricyclic Antidepressants, Barbiturates and Propoxyphene. {1}------------------------------------------------ ## Regulation Number: 21CFR862.3100, Amphetamine Test System 21CFR862.3150, Barbiturate Test System 21CFR862.3170, Benzodiazepine Test System 21CFR862.3250, Cocaine and Cocaine Metabolite Test System 21CFR862.3610, Methamphetamine Test System 21CFR862.3620, Methadone Test System 21CFR862.3650, Opiates and Test System (includes Oxycodone) 21CFR862.3700, Propoxyphene Test System 21CFR862.3870, Cannabinoids Test System 21CFR862.3910, Tricyclic Antidepressant Unclassified, Phencyclidine Regulatory Name: Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphinc, Phencyclidine, Methadone, Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene test system. Product Code: DKZ, DIS, JXM, DIO, DJC, DJR, DJG, JXN, LDJ, LFG, LCM Regulatory Class: Class II #### Predicate Devices: Forsure One Step Dip & Read Drug Screen Test Device is substantially equivalent to UCP Bioscience Rapid Drug Screening Test Strips cleared by FDA (K050540), or TNB Forsure One Step Drug Screen Test Cup Device cleared by FDA (K052882) and GC/MS for its stated intended use. ## Device Description: Forsure One Step Dip & Read Drug Screen Test consists of a or multiple chromatographic absorbent strip 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 strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen 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, 300 ng/ml of Benzodiazepine, 300 ng/ml of Methadone , 100 ng/ml of Oxycodone , 1000 ng/ml of Tricyclic Antidepressant, 300 ng/ml of Barbiturates and 300 ng/ml of Propoxyphene. 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 PRELIMINARY POSITIVE specimen produces only one color band in the control area and {2}------------------------------------------------ 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: Forsure One Step Dip & Read Drug Screen Test of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone , Oxycodone, Tricyclic Antidepressant, Barbiturates and Propoxyphene Test device 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, Benzodiazepine at cutoff concentration of 300 ng/ml, Methadone at cutoff concentration of 300 ng/ml, Oxycodone at cutoff concentration of 100 ng/ml, Tricyclic Antidepressant at cutoff concentration of 1000 ng/ml, Barbiturates at cutoff concentration of 300 ng/ml, and Propoxyphene at cutoff concentration of 300 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine, Phencyclidine, Benzodiazepine, Methadone, Oxycodone, Tricyclic Antidepressant, Barbiturates and Propoxyphene in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. #### Comparison to Predicate Device(s): Forsure One Step Dip & Read Drug Screen Test is substantially equivalent to UCP Rapid Drug Screening Test strips system cleared by FDA, e.g., the Assay (K050540) or TNB Forsure One Step Drug Screen Test Cup Device urine test ( K 052882 ) and GC/MS for its stated intended use. {3}------------------------------------------------ | Device<br>Characteristics | Subject Device | Predicate Devicce(s)<br>UCPDrug Screening Test<br>Strip ( K050540) | Predicate Devicce(s) Forsure<br>One Step Drug Screen Test<br>Cup Device ( K052882) | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The assay provides a<br>simple and rapid<br>analytical screening<br>procedure to qualitative<br>determination of different<br>abuse drug in human<br>urine | UCP Multiple Drug Screen<br>assay for qualitative<br>determination of the<br>presence of different drug<br>in human urine. | For qualitative determination<br>Of the presence of different<br>drug in human urine. | | Analytes | Amphetamine,<br>Methamphetamine,<br>Benzoylecgonine,<br>Benzodiazepine,<br>Marijuana, Morphine,<br>Phencyclidine,<br>Methadone, Oxycodone,<br>Tricyclic Antidepressant,<br>Barbiturates and<br>Propoxyphene | Amphetamine,<br>Methamphetamine,<br>Benzoylecgonine,<br>Benzodiazepine,<br>Marijuana, Morphine,<br>Phencyclidine, Methadone,<br>Oxycodone, and<br>Barbiturates | Amphetamine,<br>Methamphetamine,<br>Benzoylecgonine,<br>Benzodiazepine, Marijuana,<br>Morphine, Phencyclidine,<br>Methadone, Oxycodone,<br>Tricyclic Antidepressant,<br>Barbiturates and Propoxyphene | | Cutoff | 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,<br>BZD:300 ng/ml,<br>MAD:300ng/ml,<br>OXY:100 ng/ml,<br>BAR: 300ng/ml,<br>TCA:1000 ng/ml,<br>PPX: 300 ng/ml. | 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,<br>BZD:300 ng/ml,<br>MAD:300ng/ml,<br>OXY:100 ng/ml,<br>BAR:300 ng/ml. | 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,<br>BZD:300 ng/ml,<br>MAD:300ng/ml,<br>OXY:100 ng/ml,<br>BAR:300 ng/ml,<br>TCA:1000 ng/ml,<br>PPX:300 ng/ml. | | Test Principle | Immunochromatographic,<br>Lateral Flow | Immunochromatographic,<br>Lateral Flow | Immunochromatographic,<br>Lateral Flow | | Matrix | Urine | Urine | Urine | | Calibrator | None | None | None | | Instrument | None, Visual read single<br>use | None, Visual Read single<br>use | None, Visual Read single use | | Calibration of<br>Reagent | None | None | None | | Storage | Below 28 °C until<br>expiration | 15°C - 30°C until<br>expiration date | Below 28 °C until expiration | ## Summary: The information provided in this pre-market notification demonstrates that Forsure One Step Dip & Read Drug Screen Test is substantially equivalent to UCP Ravid Drug Screening Test strips system, TNB One Step Drug Screen Test Cup Device 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 One Step Dip & Read Drug Screen Test is safe and effective for its stated intended use. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Tianjin New Bay Bioresearch Co., Ltd. c/o Rodrigo Berlie Aventir Biotech, LLC 3108 Avenida Olmeda Carlsbad, CA 92009 NOV 2 2 2006 Re: k061617 Trade/Device Name: Forsure Onc Step Dip & Read Drug Screen Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DJS, JXM, DIO, DJC, DJR, DJG, JXN, LDJ, LFG, LCM Dated: September 26, 2006 Received: September 28, 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 cither 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). {5}------------------------------------------------ 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 logally 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 Gutt Alberto Gutierrez, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use #### 510(k) Number (if known): k061617 #### Device Name: Forsure One Step Dip & Read Drug Screen Test #### Indications for Use: Forsure One Step Dip & Read Drug Screen Test is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Benzodiazepine (BZD), Barbiturate (BAR), Cocaine (COC), Cannabinoids (THC), Opiates (OPI), Phencyclidine (PCP), Methadone (MAD), Oxycodone (OXY), Tricyclic Antidepressant (TCA) and Propoxyphene (PPX) in human urine at the following cutoff levels: | Test | Calibrator | Cutoff | |--------------------------|----------------------|------------| | Amphetamine | D-Amphetamine | 1000 ng/ml | | Methamphetamine | D-Methamphetamine | 1000 ng/ml | | Benzodiazepine | Oxazepam | 300 ng/ml | | Barbiturate | Secobarbital | 300 ng/ml | | Cocaine | Benzoylecgonine | 300 ng/ml | | Cannabinoids | 11-nor-Δ9-THC-9 COOH | 50 ng/ml | | Opiates | Morphine | 2000 ng/ml | | Phencyclidine | Phencyclidine | 25 ng/ml | | Methadone | Methadone | 300 ng/ml | | Oxycodone | Oxycodone | 100 ng/ml | | Tricyclic Antidepressant | Nortriptyline | 1000 ng/ml | | Propoxyphene | Propoxyphene | 300 ng/ml | 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 X (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) | |-------------------------------------------------------------------| |-------------------------------------------------------------------| *Division Sign-Off* | Page 1 of 1 | |-------------| |-------------| | Office of In Vitro Diagnostic Device | |--------------------------------------| | Evaluation and Safety | K041617 510(k)