REDI-SCREEN

{0}------------------------------------------------ : L993100 Attachment 4 ## 510(k) Summary This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92. The assigned 510(k) number is: 1. Date of summary: September 16, 1999 - Redwood Biotech Inc. 2. Submitted by: 3573 Westwind Blvd. Santa Rosa, CA 95403 TEL 707-577-7959 FAX 707-577-0365 Contact: Robert Mount Redi-Test Screen 3. Device Name: 4. Device Classification: Class II, Panel 91 Toxicology 5. Device description: The Redi-Screen is an immunochromatographic based one step in vitro test. 6. Intended Use: The Redi-Screen is designed for the qualitative determination of five (5) DOA and their metabolites in human urine specimens. The five DOA include THC, PCP, Opiates, Cocaine and Methamphetamine. The presence of these drugs and their cross-reacting metabolites in human urine can be detected above the following cut off levels: | THC | 50ng/mL | |-----------------|------------| | PCP | 25ng/mL | | Opiates | 300ng/mL | | Cocaine | 300ng/mL | | Methamphetamine | 1,000ng/mL | The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS, This test is for use in clinical laboratories by health care and forensic professionals only. 7. Substantial Equivalence: The Redi-Screen was found substantially equivalent to the five single tests for the individual DOA, i.e., the Redi-THC, Redi-PCP, Redi-Cocaine, Redi-Opiates and Redi-Methamphetamine. All products are immunoassays and use specific antibodies to detect various drug compounds. Both predicate and modified tests are preliminary screens for human urine and require confirmation with alternate methods such as GC/MS. The performance testing for both tests were similar in all aspects including; comparison studies which ranged between >96% and > 99% {1}------------------------------------------------ agreement when compared to commercially available EIA DOA tests, precision studies, which both demonstrated a high degree of reproducibility, specificity which indicated no cross reaction with several unrelated drug compounds, and validation of drug cut offs which were within ±25% of the cut off for both tests. ## Conclusion: The Redi-Screen is substantially equivalent in all performance characteristics to the individual Redi-Test THC, Opiates PCP, Cocaine and Methamphetamine. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads. The eagle is facing to the right. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 6 1999 Redwood Biotech Inc. c/o Ms. Janis Freestone Advantage Diagnostics Corporation 2440 Leghorn Street Mountain View, California 94043 Re: K993100 Trade Name: Redi-Screen Regulatory Class: II Product Code: DJC, LDJ, DIO, DJG, Dated: September 15, 1999 Received: September 16, 1999 Dear Ms. Freestone: 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 Cosmetic 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 OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the 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 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 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 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"(21 CFR 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/cdrlvdsma/dsmamain.html". Sincerely yours, Steven Sutman 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}------------------------------------------------ Attachment 2 510k Number: Device Name: Redi-Screen Indications for Use: The Redi-Screen is a qualitative, one step, immunochromatographic competitive assay The Redi-Screen human urine for the presence of THC, Phencyclidine, Opiates, Cocaine and Methamphetamine at the following cut off concentrations; | THC | 50ng/mL | |-----------------|------------| | РСР | 25ng/mL | | Opiates | 300ng/mL | | Cocaine | 300ng/mL | | Methamphetamine | 1,000ng/mL | The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS. Jean Cooger (Division Sign-Off) Division of Clinical Laborator Devices 510(k) Number K993100. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over the counter use ***_***