RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020

{0}------------------------------------------------ ## 510 (k) SUMMARY (21 CFR PART 807.92) #### Product Rapid Methadone Test Strip and Rapid Methadone Test Card #### Name of Manufacturer Rapid Diagnostics, Division of ICN BIOmedicals Inc. 1429 Rollins Road, Burlingame, CA 94010, U.S.A. #### Principle The RapidMTD test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding anti-methadone antibody between methadone-protein conjugate and free drug which may be present in the urine specimen being tested. When methadone is present in the urine specimen, it competes with methadone-protein conjugate for the limited amount of antibody-colloidal conjugate. When the amount of methadone is equal or more than the cut-off, it will prevent the binding of methadone-protein conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line composed of Goat anti-Mouse IgG antibody is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately. #### Intended Use The RapidMethadone Tests are immunochromatography based one step in vitro test. It is designed for qualitative determination of methadone in human urine specimen above the cutoff level of 300 ng/ml. #### Performance The studies performed are listed below: Rapid Methadone Test Strip Sensitivity Accuracy (comparison study of clinical urine specimens) Stability - Specimen {1}------------------------------------------------ Stability – Product Precision Reproducibility Specificity Interference Rapid Methadone Test Card Accuracy (comparison study of clinical urine specimens) Precision Comparison between Rapid Methadone Test Strip and Test Card Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Methadone Test Strip and Rapid Methadone Test Card. The results of performance characteristics demonstrate Rapid Methadone Test Strip and Rapid Methadone Test Card to be substantially equivalent to the Applied Biotech SureStep ™ Drug Screen Test Methadone, which received 510 (k) approval. {2}------------------------------------------------ # PRODCUT DESCRIPTION Rapid Methadone Test Strip is a dipstick device for detecting the presence or absence of the tested drug. The test strip is also used for the composition of Rapid Methadone Test Card. These test devices are manufactured with the same formulation and procedure except the test card consists a plastic housing containing one methadone test strip. There is no any functional design that may affect the test strip's performance in the test card. ## A. Test Strip Test strips that containing absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, are used to assemble Rapid Methadone Test Strip as shown below: Image /page/2/Figure/5 description: The image shows a diagram of a lateral flow assay strip. The strip is divided into four sections: an absorbent pad, a coated membrane, a gold conjugate pad, and a sample pad. The absorbent pad is at the top of the strip, and the sample pad is at the bottom. ## B. Test Card Format The above test strip that contains an absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, is used to assemble the Test Card Device as shown below. Image /page/2/Figure/8 description: The image shows a diagram of a test strip, likely for a medical or scientific assay. The diagram labels three key areas: the "Control Band," the "Test Band," and the "Sample Well." These labels indicate the regions where control reactions, test results, and sample application occur, respectively, on the strip. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines. Food and Drug Administra 2098 Gaither Road Rockville MD 20850 Mr. Charles Yu Director of Technical Operation Official FDA Correspondent ICN Biomedicals, Inc. Rapid Diagnostics 1429 Rollins Road Burlingame, CA 94010 k023252 Re: > Trade/Device Name: Rapid Methadone Test Card Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: September 23, 2002 Received: September 30, 2002 Dear Mr. Yu: 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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html. Sincerely vours. Steven Sutman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Attachment page 5 ## INDICATIONS FOR USE STATEMENT 510 (K) number (if known): _ K023252_ .. _____________________________________________________________________________________________________________________________________ Device Name: Rapid Methadone Test Strip Indications for Use: Rapid Methadone Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result. Concurrence of the CDRH, Office of Device Evaluation (ODE) ﻢ Prescription Use: (Per 21 CFR 801.109) OR Over the Counter Use: {6}------------------------------------------------ Attachment page # INDICATIONS FOR USE STATEMENT 510 (K) number (if known): K023252 Device Name: Rapid Methadone Test Card Indications for Use: Rapid Methadone Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result. Concurrence of the CDRH, Office of Device Evaluation (ODE) Alan Cooper (Division Sign-Off) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K023252 Prescription Use: (Per 21 CFR 801.109) OR Over the Counter Use: