QUICK CARD HCG ONE STEP PREGNANCY TEST

{0}------------------------------------------------ Fax:6196355843 0:06 P. 04 K973570 OCT 3 1 1997 ## 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(C) Identification: QuickCard HCG One Step Pregnancy Test (9011) Description: Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Detection of Early Pregnancy Name of Manufacturer: Phamatech 9265 Activity Road #112 San Diego, California, 92126, USA Intended Use: The QuickCard HCG One Step Pregnancy Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. HCG is a well know and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration. Technology: The QuickCard HCG One Step Pregnancy Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Unipath Clearview HCG (Mountainview, CA 94043), Abbot Laboratories' Fact Plus (Abbot Park, IL 60064) and the Syntron Bioresearch Be Sure Pregnancy Test (Carlsbad, CA 92008). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / HCG / antibody complexes. Performance: The product performance characteristics of the QuickCard HCG One Step Pregnancy Test were evaluated in a clinical sample correlation study and a blind labeled spiked HCG study. The results of these studies demonstrate the Phamatech QuickCard HCG One Step Pregnancy Test to be substantially equivalent to the reported performance characteristics of other commercially available test for the qualitative detection of early pregnancy. Correlation studies, using clinical specimens, produced a >99% correlation when compared to the Quidel RapidVue (San Diego, CA 92121) and the Syntron Bioresearch Be Sure Pregnancy Test (Carlsbad, CA 92008). A blind labeled spiked consumer study was performed; the Phamatech QuickCard exhibited excellent sensitivity (122/123), specificity (122/123), and accuracy (244/246) in the hands of lay users. Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickCard HCG One Step Pregnancy Test is substantially equivalent to a variety of pregnancy tests currently in commercial distribution. {1}------------------------------------------------ # IV. Consumer Survey: Introduction: - A study was conducted at five geographically distinct locations using a panel . of coded specimens to demonstrate that lay people, not clinical professic nals, could perform the QuickCard HCG One Step Pregnancy Test reprodicibly and obtain accurate results. The proficiency panel contained negative (0 mIU/mL) and low positive (40 mIU/mL) hCG urine specimens. - Individuals were instructed to follow the QuickCard HCG One Step Pregr ancy . Test package insert to perform and read the assay. In no case was them any verbal communication between the trial participant and Phamatech with regard to assay procedure or interpretation. Trial participants were sur plied with coded specimens and QuickCard HCG One Step Pregnancy Tests. Most participants received a set containing 1 coded positive sample and 1 c >ded negative sample. One participant received 2 coded negative samples. ### Study Population: - . Trial participants ranged in age from 16 to 55 years of age. Respondents were of diverse occupational backgrounds, from students and housewivi s to accountants, chemists and pharmacists. Approximately 25% of the respondents were of Asian decent, 10% were Hispanic, while the rema nder were African American and Caucasian. ### Study Design: - Coded urine samples were prepared as follows: . Samples 1 and 3 were normal pooled male urine samples spiked o 40 mIU/mL hCG (WHO 1st IRP). Samples 2 and 4 were 0 mlU/mL hCG. - . Trial participants each were sent two (2) QuickCard HCG One Step Pregnancy Tests, two (2) coded samples, 1 pair of latex gloves and ge neral instructions (see page 39). Included in each "kit" was a survey explanati on, a questionnaire (see page 40) and a self-addressed, stamped envelope. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. Public Health Service .......................................... Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 31 1997 Tuan Pham President Phamatech, Inc. 9265 Activity Road, # 112/113 San Diego, California 92126 Re : K973570 Quick Card HCG One Step Preqnancy Test Requlatory Class: II Product Code: LCX Dated: August 17, 1997 - -September 19, 1997 Received: Dear Mr. Pham: 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 regulations 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 finding of substantial equivalence of your device to a leqally 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/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}------------------------------------------------ #### INDICATIONS FOR USE l Applicant: Phamatech 510(k) Number (if known): Device Name: QuickCard HCG One Step Pregnancy Test Indications for Use: An &CG pregnancy test intended for over the counter use by lay persons is an in An nCG pregnancy to the qualitative identification of human Chorionic Gonadotropin (hCG), a human hormone, in urine. Measurements that are optained by this device are used in the diagnosis of pregnancy. PLEASE DO NOT WRITE BELOW THIS LINE Concurrence of CDRH Office of Device Evaluation (ODE) Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number: Prescription Use: __ Over the Counter: _ Per 21 CFR 801.109 OR (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number. K973570