CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE

{0}------------------------------------------------ i x 1<1x # SUMMARY OF SAFETY AND EFFECTIVENESS #### Product: AUG 29 1991 CARDS® Q.S.® hCG-Urine; or Concise® Performance Plus™ hCG-Urine #### Distributor: Pacific Biotech, Incorporated; a subsidiary of QUIDEL Corporation 10165 McKellar Court San Diego, CA 92121 U.S.A. #### Device Classification: The device, CARDS Q.S. hCG-Urine (also sold under the brand name Concise Performance Plus hCG-Urine), is similar to other FDA-cleared devices used for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The test is used in the early detection of pregnancy and is intended to measure hCG, a placental hormone, in urine (21 CFR 862.1155). The FDA has proposed that hCG test systems be classified as Class II. #### Intended Use: The test is a rapid immunoassay for the qualitative detection of hCG in urine. This test is to be used for the early detection of pregnancy. #### Physiologic Basis for the Assay: Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the trophoblastic cells of the developing placenta as early as 7 to 8 days after ovulation. This hormone stimulates the production of progesterone and estradiol which are required to sustain pregnancy. In normal pregnancy, serum levels of hCG continue to rise during the first trimester to levels as 'high as 100,000 mIU/mL. Serum hCG is rapidly cleared in the urine and the concentration of hCG in serum is approximately equal to the concentration in urine. HCG is an excellent indicator of pregnancy early in the gestational period. {1}------------------------------------------------ ### Principle of the Test: The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. Shortly after addition of the urine sample, a blue procedural Control Line will appear. If hCG is present in the sample, a pinkto-purple Test Line intersecting the pre-printed horizontal blue line will also appear. The result is read at three minutes after sample application. If no blue procedural Control Line develops, the result is considered invalid. ## Safety and Effectiveness: Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to other commercially available products for the qualitative detection of hCG in urine. These studies included the following: - · The test was shown to be similar to other commercially distributed in vitro tests in terms of features and intended use. - · The test was shown to have excellent intra- and inter-assay precision. - · Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable. - · Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance. - · Using urine samples obtained from women presenting for pregnancy testing, a direct comparison of the test to other FDA-cleared devices for qualitative hCG detection was conducted. An accuracy exceeding 99% was observed. - · Physician's Office Laboratory studies were conducted to show that doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed greater than 99% with the expected results. ## Conclusion: These studies demonstrated the substantial equivalence of the test to existing products already marketed. They further demonstrated the suitability of the product for use by health care professionals. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an affiliation with a public health organization. Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, rendered in black lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image. AUG 2 9 1997 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Robin Weiner . Vice President, Clinical Develop. & Reg. Affairs OUIDEL Corporation -10165 Mc Kellar Court San Diego, California 92121 K972748 Re : CARDS® Q.S.® hCG-Urine; Concise® Performance Plus™ hCG-Urine Regulatory Class: II Product Code: JHI Dated: July 22, 1997 Received: July 23, 1997 Dear Ms. Weiner: 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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation (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 requlations. {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 assorizoof 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 diaqnostic 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/dsmamain.html". Sincerely yours, Steven Litman 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 _______________________________________________________________________________________________________________________________________________________________ ਹੈ। ਹ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: ## CARDS® Q.S.® hCG-Urine Concise® Performance Plus™ hCG-Urine Indications for Use: The CARDS® Q.S.® hCG-Urine (also sold under the brand name The CARDSO Qlonce Plus™ hCG-Urine) is a one-step immunoassay Concises for the qualitative detection of human chorionic Intended - 101 - and of the early detection of pregnancy. The test is intended for use by health care professionals. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number 59472748 Prescription Use (Per 21 CFR 801.109) OR Over-The Counter Use_ (Optional Format 1-2-96)