INSTANT-VIEW PREGNANCY COMBO TEST

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date 2/16/99 at the top left corner. Below the date is the logo for Alfa Scientific Designs, Inc. The logo is a stylized "alpha" symbol. The text "ALFA SCIENTIFIC DESIGNS, INC." is to the right of the logo. Medical Diaqnostic Devices. Contract R&D. OEM 11494 Sorrento Valley Rd, Suite F & M San Diego, CA 92121 Tel: (619) 350-9798 Fax: (619) 350-9709 # Fax: (19/35-975E-mail: asdi@worldnet.att.net 510(K) Summary (K984077) # Submitter Name and address: Alfa Scientific Designs, Inc. 11494 Sorrento Valley Rd, Suite M San Diego, CA 92121 619-350-9798 (Tel) 619-350-9709 (Fax) Contact Person: Naishu Wang, MD, Ph.D. Date Prepared: 12/30/98 #### Device Name Trade Name: Instant-View™ Pregnancy Combo Test Common Name: Human Chorionic Gonadotropin (hCG) Test Classification name: 21CFR section 862.1155, Class II. A Qualitative Human Chorionic Gonadotropin (hCG) test system. ### Predicate device The Instant-View TM Pregnancy Combo Test is substantially equivalent to other legally marketed devices for the similar intended use. The device used for comparison study is the QuikpacII-One Step HCG Combo Test made by Syntron Bioresearch, Inc. The 510(K)# is K945951. # Device description A single step, visually read, qualitative chromatographic immunoassay, single use cassette test #### Intended use The Instant-View TM Pregnancy Combo Test is designed for qualitative detection of the human chorionic gonadotropin (hCG) in human urine and serum. The test is for use as an aid in the diagnosis of early pregnancy. Continued on next page 510(K) Summary {1}------------------------------------------------ | Summary of the<br>similarities to the<br>predicate device | • The intended use and performance characteristics:<br>Both devices are intended to use for an early detection of hCG<br>in human urine and serum at the level close to or greater than 25<br>mIU/ml (calibrated against the WHO 3rd IS 75/537). | |-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | • Technological characteristics:<br>Both devices are one step, qualitative, visual lateral flow<br>immuno-Chromatographic test in a sandwich complex format of<br>anti-hCG antibody /hCG/ anti-hCG antibody. | | | • Interpretation of results:<br>The presence of C line serves as an internal quality control, and<br>the presence of the T line indicates a positive result. | | Discussion and<br>Conclusion | • The accuracy by correlation of the results from the Instant-<br>View ™ Pregnancy Combo Test and the legally marketed test<br>compared is 100%, indicating that the Instant-View ™<br>Pregnancy Combo Test is substantially equivalent to this<br>existing legally marketed product. | | | • The evaluation results from clinical lab and three physician's<br>offices conducted by the persons with diverse educational<br>backgrounds and working experience agreed 100% with the<br>results expected. | | | • Based on the results of the correlation and POL studies, we may<br>conclude that the Instant-View ™ Pregnancy Combo Test is as<br>safe, as effective, and performs as well as the legally marketed<br>device. Therefore, this test is suitable for use by health care<br>professionals with diverse educational backgrounds and work<br>experience. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a triple-stranded helix design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 FEB 1 6 1999 Naishu Wang, M.D., Ph.D. President Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road, Suite F&M San Diego, CA 92121 Re: K984077 Trade Name: Instant-View Pregnancy Combo Test Regulatory Class: II Product Code: 75 JHI Dated: January 6, 1999 Received: January 11, 1999 Dear Dr. Wang: 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 QS 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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}------------------------------------------------ Page 14 of 14 | <strong>Labels</strong> | <strong>Values</strong> | |--------------------------|-----------------------------------| | 510(k) Number (if known) | K984077 | | Device Name | Instant-View pregnancy Combo Test | Indications For Use: The Instant-View Pregnancy Combo Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. This test is for laboratory and professional use only. in 66 (Division Sign-Off) (Division of Clinical Laboratory Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)