MESACUP TEST PR-3

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a logo with a black background and white text and graphics. The text "Rhibene" is at the bottom of the logo in a bold, stylized font. Above the text is a graphic that resembles a molecule or a stylized plant with a curved stem. There is also a curved line extending from the right side of the graphic. ## SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS MESACUP Test PR-3 March 30, 2004 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 The MESACUP Test PR-3 is compared to a legally marketed predicate device and a substantial equivalence claim made. The predicate device is Bindazyne Human Anti-PR3 Enzyme Inutumoassay Kit (K981029) currently manufactured and marketed by The Binding Site Ltd., Birmingham, U.K. The MESACUP Test PR-3 is an enzyme-linked inununosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with proteinase III antigen. Incubation allows the anti-PR-3 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for haman IgG immunoglobulins. labeled with horseradish peroxidase (HRP), are added forming complexes with the PR-3 bound antibodics. Following another washing step. The bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzioine (TMB) and lydrogen peroxide (H2O2) as the chromogenic substrate, The intensity of the color generated is proportional to the scrum concentration of anti-PR-3 antibodies, Optical density is read spectrophotometrically at 450mm. The total incubation time (at toom The assay makes use of two calibrators to measure the amount tomperature) of the assav is 150 minutes. of anti-PR-3 antibody in patient samples. The intended use of the device is a somi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-proteinase III (PR-3) antibodies in human serum. The MESACUP Test PR-3 is intended for in vitro diagnostic use as an aid in the diagnosis of certain systematic vasculitides such as Wegence's granulomatosis. Performance indicates that MESACUP Test PR-3 and the Bindazyme Human Anti-PR3 Enzyme Immunoassay are equivalent. In-house studies indicate a clinical specificity of 100% for anti-PR-3 antibodies in a healthy donor serum population on both kits. Additional studies resulted a sensitivity of 35% with a vasculitis population on both assay for anti-PR-3 antibadies compared to IIF ANCA positive results and 87% for both assays specifically for cANCA positive IIF petterns. In general, the performance characteristics are comparable between the two methods (100% relative agreement). Yuck Robe Yusuke Kobe Vice President, Sales and Marketing Department 3/30/2004 --- Date Fax: 455 State St. Ste 104 (847) 375-9093 Des Plaines, IL 80016 {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three flowing lines, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic. APR - 2 2004 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Nanci Dexter Director of Quality/ Regulatory Affairs RhiGene, Inc. c/o Corgenix, Inc. 12061 Tejon St. Westminister, CO 80234 k040711 Re: Trade/Device Name: MESACUP TEST PR-3 Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MOB Dated: March 10, 2004 Received: March 18, 2004 Dear Ms. Dexter: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {2}------------------------------------------------ Page 2 If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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, Joseph L. Aralett Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Statement 510(k) Number: K040711 Device Name: MESACUP TEST PR-3 Indications for Use: The MESACUP TEST PR-3 is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-proteinase III (PR-3) antibodies in human serum. The MESACUP TEST PR-3 is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as Wegener's granulomatosis. The MESACUP TEST PR-3 is intended to be used by clinical (hospital and reference) laboratories. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V (per 21 CFR 801.109) OR Over-The-Couter Use_ Optional Format 1-2-96) Maria Chan Division Sign Off ivision Sian Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K040711