INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Alfa Scientific Designs, Inc. The logo is a stylized "alpha" symbol. Above the logo is the date 2/16/99. Medical Diagnostic Devices. Contract R&D. OEM 11494 Sorrento Valley Rd, Suite F & M San Diego, CA 92121 Tel: (619) 350-9798 Fax: (619) 350-9709 E-mail: asdi@worldnet.att.net ## 510(K) Summary (K984075) | Submitter | Name and address: Alfa Scientific Designs, Inc.<br>11494 Sorrento Valley Rd, Suite M<br>San Diego, CA 92121 | |-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 619-350-9798 (Tel)<br>619-350-9709 (Fax) | | | Contact Person: Naishu Wang, MD, Ph.D. | | | Date Prepared: 1/8/99 | | Device Name | Trade Name: Instant-ViewTM Pregnancy Urine Mid-Stream Test | | | Common Name: Human Chorionic Gonadotropin (hCG) Test | | | Classification name: 21CFR section 862.1155, Class II.<br>A Qualitative Human Chorionic<br>Gonadotropin (hCG) test system. | | Predicate device | The Instant-ViewTM Pregnancy Urine Mid-Stream Test is<br>substantially equivalent to OSOM Pregnancy Urine Test made by<br>Wyntek Diagnostic, Inc., 510K#: K954178. | | Device description | A qualitative visual immuno-chromatographic assay, single step,<br>single use stick test | | Intended use | The Instant-ViewTM Pregnancy Urine Mid-Stream Test is a home<br>pregnancy urine test for use as an aid in the diagnosis of early<br>pregnancy. | | | Continued on next page | | Summary of the<br>similarities to the<br>predicate device | • The intended use and performance characteristics:<br>Both devices are OTC devices intended to use for an early<br>detection of hCG in human urine.<br>• Technological characteristics:<br>Both devices are one step, qualitative, lateral flow, visual<br>immuno-chromatographic test in a sandwich complex format of<br>anti-hCG antibody /hCG/ anti-hCG antibody.<br>• 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 consumer studies demonstrated that the results obtained from<br>consumers were 100% agreed with that obtained from the<br>professionals and the actual patient status. No discrepancy was<br>found between the results obtained by the professionals from the<br>subject device and the predicate device.<br>Over 99% of the consumers found the Instant-ViewTM Pregnancy<br>Urine Mid-Stream Test is simple, fast, convenient and accurate. | | | • The comparison studies demonstrated that the accuracy by<br>correlation of the results from the Instant-ViewTM Pregnancy<br>Urine Mid-Stream Test and the predicate device was 100%. It<br>indicates that the Instant-ViewTM Pregnancy Urine Mid-Stream<br>Test is substantially equivalent to the predicate device. | | | • The evaluation results from three POL sides agreed 100% with<br>the results expected, indicating that the testing results are highly<br>repeatable. | | | • Based on the results of the correlation study, consumer study and<br>POL evaluations, we may conclude that the Instant-ViewTM<br>Pregnancy Urine Mid-Stream Test has excellent intra- and inter-<br>assay precision. It is as safe, as effective, and performs as well<br>as the legally marketed OTC device. Therefore, this device is<br>suitable for use as an OTC pregnancy test. | K984076 {1}------------------------------------------------ ## Continued {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure, with three lines forming the body and head. 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: K984075 > Trade Name: Instant-View Pregnancy Urine Mid-Stream Test Regulatory Class: II Product Code: 75 LCX Dated: January 8, 1999 Received: January 12, 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 (OS) 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 Autman 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 l of 1 510(K) NUMBER (IF KNOWN): K 984075 DEVICE NAME : Instant-View™ Pregnancy Urine Mid-Stream Test INDICATIONS FOR USE: This test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. This test is for Over-The-Counter use only. ean Looxh (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K984075 (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 (Optional Format 1-2-96) .2//8