INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST

{0}------------------------------------------------ K994400 ## Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road, Suite M San Diego, CA 92121 # 510(K) Summary In accordance with the Safe Medical Devices Act of 1990, a 510(K) summary is provided as outlined in 21 CFR 807.92. | Submitter | Name: | Alfa Scientific Designs, Inc. | |-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Address: | 11494 Sorrento Valley Road, Suite M<br>San Diego, CA 92121<br>Telephone: (858) 350-9798<br>Fax: (858) 350-9709<br>Email: asdi@worldnet.att.net | | Device Name | Trade Name: | Instant-View™ Methamphetamine Urine<br>Cassette Test | | | Common Name: | Methamphetamine Test | | | Classification Name: | 21 CFR 862.3610, Class II | | Predicate Device | The Instant-View™ Methamphetamine Urine Cassette Test<br>is substantially equivalent to other legally marketed devices<br>for the similar intended use. The device used for<br>comparison study is QuikStrip One Step Methamphetamine<br>Test, manufactured by Syntron Bioresearch, Inc. with<br>510(K) #: K970395, Date of Approval: 06/26/97. | | | Device Description | This test is a one-step lateral flow chromatographic<br>immunoassay. | | | Intended Use | The Instant-View™ Methamphetamine Urine Cassette Test<br>is a qualitative immunoassay device intended to detect<br>methamphetamine in human urine at a cutoff level of 500<br>ng/ml. It is intended for health care professional use only. | | | Summary of the<br>Similarities to the<br>Predicate Device | • Intended Use: | Both devices are intended to detect methamphetamine in<br>human urine at a cutoff level of 500 ng/ml. | | | | • Interpretation of results:<br>The appearance of only one line - C line, indicates a<br>Positive result, and that the methamphetamine level is at<br>a cutoff level of 500 ng/ml or higher. And, the<br>appearance of two lines - both C line and T line indicates | | Discussion and<br>Conclusion | a negative result, and the methamphetamine level is<br>below 500 ng/ml.<br><br>• Technological Characteristics:<br>Both devices are one step, qualitative, competitive<br>binding immunoassay test, utilizing the basic<br>immunochemical sandwich assay principle of<br>recognition and formation of the specific<br>Methamphetamine/Antibody/Methamphetamine<br>complexes.<br><br>• The correlation of results from the Instant-View™<br>Methamphetamine Urine Cassette Test, is higher than<br>97.5 %. The results from all three POL sites agreed<br>98.3 %.<br><br>• The Accuracy Evaluation results from the Clinical<br>Laboratory conducted by persons with diverse<br>educational background and working experiences agreed<br>95.2% with the expected results.<br><br>• Based on the results of the Performance Characteristics<br>and Comparison Studies, it may be concluded that the<br>Instant-View™ Methamphetamine Urine Cassette Test<br>is suitable for use by health care professionals with<br>diverse educational backgrounds and work experiences,<br>and it is substantially equivalent to the existing legally<br>marketed device. | | {1}------------------------------------------------ ﺗ : . {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human figures or profiles facing to the right, stacked on top of each other. ### Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 #### AUG 4 2000 Ms. Rhoda Filipina OA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121 K994400 Re: Trade Name: Instant-View Methamphetamine Urine Cassette Test Regulatory Class: II Product Code: DJC Dated: June 30, 2000 Received: July 6, 2000 Dear Ms. Filipina: 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 (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 Cornetic 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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to moponents, atte GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 This letter will allow you to begin marketing your device as described in your 510(k) premarker 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrls/dsmamain.html". Sincerely yours. Steven Butman 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 {4}------------------------------------------------ Page 1 of 1 K994400 510(k) Number (if known): Instant-View Methamphetamine Urine Cassette Test Device Name: Indications For Use: Instant-View Methamphetamine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect methamphetamine in human urine at a cutoff level of 500 ng/ml. It is intended for health care professional use only. The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the screening levels for Methamphetamine to be at a concentration of 1000 ng/ml. This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preférred confirmatory method. matographyrinass Specif oprofessional judgment should be applied to any drug of abuse, Chilled Consideration and positive results are used. Land (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number. K994400 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use er-ine-councer -8-9-96)