QUICKCARD HCG COMBO TEST, MODEL #9014

{0}------------------------------------------------ 4/28/99 K 9910895 ## 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C) ## QuickCard hCG Combo Test (9014) ldentification: Immunoassay for the Qualitative Detection of Human Chorionic Description: Gonadotropin (hCG) in Urine or Serum for the Early Pregnancy Name Of Manufacturer: Phamatech 9265 Activity Road #112 San Diego, California 92126, USA The QuickCard hCG Combo Test is intended to detect the Intended Use: presence of Human Chorionic Gonadotropin (hCG) in urine or Serum. HCG is a well known and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration. This device is intended for clinical laboratories and physician's office labs as an IVD test for the qualitative measurement of hCG in urineor serum. The QuickCard hCG Combo Test, like many commercially available Technology: preqnancy 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), Abbott Laboratories' Test Pack Plus (Abbott Park, IL 60064) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083). 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 Combo 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 Combo Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of early pregnancy. Correlations studies, using clinical specimens, produced a >98% correlation when compared to the Quickvue (San Diego, CA 92121), the Phamatech QuickCard hCG Pregnancy Test (9008) and the Abbott Test Pack Plus (Abbott Park, III.). For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickCard hCG Combo Test is substantially equivalent to a variety of pregnancy tests currently in commercial distribution. {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service APR 2 8 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road #112 San Diego, California 92126 Re: K991095 Trade Name: Phamatech OuickCard™ hCG Combo Test Regulatory Class: II Product Code: JHI Dated: March 31, 1999 Received: April 1, 1999 Dear Mr. Mongiovi: 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. {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 Applicant: Phamatech 510 (k) Number (if known): _ 99 j095 Device Name:_QuickCard™ hCG Combo Test Indications for Use: ) Status and This test detects hCG in urine or serum. hCG is a hormone produced by the placenta shortly after implantation. Since hCG is present in the urine and serum of a pregnant woman, it is an excellent marker for confirming pregnancy. This device is intended for clinical laboratories and physician's office laboratories (POL's) as an IVD test for the qualitative measurement of hCG in urine or serum. Tean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices x 191695 510(k) Number _ PLEASE DO NOT WRITE BELOW THIS LINE Concurrence of the CDRH Office of Device Evaluation (ODE) Division Sign-off Division of Clinical Laboratory Devices | 510 (k) Number: | | |-----------------|--| |-----------------|--| | Prescription Use: | <div style="display:inline-block; vertical-align:bottom;">✓</div> | OR | Over the Counter: | | |--------------------|-------------------------------------------------------------------|----|-------------------|--| | Per 21 CFR 801.109 | | | | |