GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY

{0}------------------------------------------------ zyme Diagnostics/Medix Biotech subsidiary 1983399 Contrast® GiardialCryptosporidium Combo Rapid Assay Reference No. K983399 December 23, 1998 San Carlos, CA 94070 JAN 1 1 1999 Industrial Road ## CONFIDENTIAL ## ATTACHMENT 1 #### 510(k) Summary Of Safety and Effectiveness Information | Trade or Proprietary Name: | Giardia/Cryptosporidium Combo Rapid Assay | | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--| | Common or Usual Name: | Immunoassay for Giardia and Cryptosporidium Antigens | | | Manufacturer: | Genzyme Diagnostics<br>Medix Biotech subsidiary<br>1531 Industrial Road<br>San Carlos, CA 94070 | | | Contact Person: | Barbara Pizza, Manager Regulatory Affairs, (617) 252-7953<br>Genzyme Diagnostics<br>One Kendall Square, Building 200<br>Cambridge, MA 02139-1562 | | The use of the Genzyme Contrast@ Giardia/Cryptosporidium Combo Rapid Assay in the clinical laboratory setting is substantially equivalent to a currently marketed method for Giardia and Cryptosporidium for the detection of Giardia and Cryptosporidium antigen in aqueous fecal specimens. #### PERFORMANCE STUDIES: #### Comparative Performance Studies A Comparative performance study was conducted using the Genzyme GiardialCryptosporidium Assay, a Reference method (microscopic examination) and predicate method (Alexon ProSpecT). The summary of the sensitivity and specificity are provided below. | | Sensitivity | Specificity | |-----------------------------------------------------------|---------------|--------------------| | Retrospective Analysis Genzyme vs Microscopic examination | | | | Giardia | 33/33 = 100% | 109/109 = 100% | | Cryptosporidium | 36/37 = 97.3% | 105/105 = 100% | | Prospective Analysis Genzyme vs Microscopic examination | | | | Giardia | 50/50 = 100% | 448/452 = 99.1% | | Cryptosporidium | 73/73 = 100% | 427/429 = 99.5% | | Retrospective Analysis Genzyme vs Rapid EIA | | Relative Agreement | | Giardia | | 138/142 = 97.2% | | Cryptosporidium | | 142/142 = 100% | The Genzyme method yielded acceptable relative agreement with the predicate method. {1}------------------------------------------------ ## Agreement Both within-run and between-run studies were performed using Giardia and Cryptosporidium positive and neqative stool specimens. Five replicates of each specimen stool pool (Giardia positive, Cryptosporidium positive and GiardialCryptosporidium negative) was tested five times in one batch using the Contrast Giardial Cryptosporidium Combo Rapid Assay over five days. The Agreement was calculated for each stool specifications for within and between-run precision were 100% agreement. ## Conclusion Based on the results of the performance studies described above, the Genzyme Contrast Giardial Cryptosporidium Combo Rapid Assay is substantially equivalent in performance to the reference method (Standard microscopic examination) and to the predicate (Alexon ProSpecT) a legally marketed method for the detection of Giardia and Cryptosporidium antigen in aqueous fecal specimens. In lieu of a 510(k) statement under 513(i) of the Act, this information is provided as a 510(k) summary for disclosure to any other persons/companies without the specific written authorization from Genzyme Corporation. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JAN 1 1 1999 Barbara Pizza Manager, Regulatory Affairs Genzyme Diagnostics One Kendall Square Cambridge, MA 02139-1562 K983399 Re: Trade Name: Contrast® Giardia/Cryptosporidium Combo Rapid Assay Regulatory Class: II Product Code: MHI Dated: December 23, 1998 Received: December 24, 1998 Dear Ms. Pizza: 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 OS 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 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 {4}------------------------------------------------ Page__________________________________________________________________________________________________________________________________________________________________________ of 1 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name:4 Contrast® Giardia/Cryptosporidium Combo Rapid Assay Indications For Use: This is an immunochromatographic assay for the simultaneous qualitative detection and distinguishing of Giardia and Cryptosporidium specific antigens in aqueous extracts of fecal specimens. It is intended for professional laboratory use. For In Vitro Diagnostic Use. Woody Dubois vision of Clinical Laboratory Devices 510(k) Number. PRESCRIPTION USE X