ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY

{0}------------------------------------------------ K991369⊕ ## "Summary of Safety & Effectiveness" The AccuDip™ Home Pregnancy Test and/or AimStick™ Pregnancy is intended for non-professional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. The test utilizes a combination of monoclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by dipping the absorbent wick of the test in urine and observing for the formation of colored liness. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specific antibody-hCG-colored conjugate and form a colored line on the Specimen portion of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Zone will always appear regardless of the presence or absence of hCG. The AccuDip™ Home Pregnancy test detects hCG concentrations of 20 mIU/ml and greater. The test has been standardized to the World Health Organizational Standard. The addition of hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity. Clinical trials using AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy were conducted which included 73 female participants. The results of the study showed that the majority of the participants found AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results. The overall results of the clinical trial confirm that AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy is a suitable test for over-the-counter pregnancy testing Maitre O'connor 4-14-94 Date K991369 arket Notification 510(k) Number {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. MAY 1 0 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Martin O'Connor General Manager Germaine Laboratories, Inc. 4203 Gardendale Center, #230 San Antonio, TX 78229 Re: K991369 Trade Name: AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy Regulatory Class: II Product Code: LCX Dated: April 19, 1999 Received: April 20, 1999 Dear Mr. O'Connor: 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. {2}------------------------------------------------ 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/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Putman 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 {3}------------------------------------------------ ## Indications For Use 510(k) Number: K991369 Device Name: AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy "Indications For Use" - AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy is intended for non-professional over-the-counter use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. Sean Cooper Division Sign-Off) Trision of Clinical Laboratory Devices 510(k) Number (Please do not write below this point) Concurrence of CDRII, Office of Device Evaluation (ODE) Prescription Usc (per 21 CFR 801.109) or