VISULIZE FACTOR IX ANTIGEN KIT

{0}------------------------------------------------ K05105-54 # JUN 2 9 2005 ## Section H ## 510(k) Summary for VisuLize™ Factor IX Antigen Kit (Summary of Safety and Effectiveness) This summary of 510(k) safety and effectiveness information is being submitted in Sammary of STO(K) Sarety in ments of SMDA 1990 and 21 CFR 807.92. | Submitted By: | Affinity Biologicals Inc.<br>1395 Sandhill Drive<br>Ancaster, ON<br>Canada, L9G 4V5<br>Phone: 905-304-9896<br>Fax: 905-304-9897 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Denise Foulon, Scientific Director<br>Phone: 905-304-9896<br>Fax: 905-304-9897 | | Summary Prepared: | April 25, 2005 | | Name of the Device: | VisuLize™ Factor IX Antigen Kit<br>Common Name: Factor IX ELISA assay | | Classification of Device: | Class II<br>21 CFR 864.7290, Factor Deficiency Test<br>Subpart H, Hematology Kits and Packages<br>Product Code: GGP | | Predicate Device: | Asserachrom IX:AG, K854312<br>Diagnostica Stago (formerly American Bioproducts) | | Device Description: | The VisuLize™ Factor IX Antigen kit is a sandwich enzyme-<br>linked immuno-sorbent assay (ELISA) using a polyclonal<br>antibody coated 96-microwell format. Plasma samples are<br>diluted and applied to the pre-coated wells. After washing away<br>unbound proteins, a horseradish peroxidase (HRP) labelled<br>polyclonal antibody is applied to detect the captured Factor IX. A<br>chromogenic substrate (TMB containing H2O2) is added to allow<br>for color development. The color formed is measured<br>spectrophotometrically at 450 nm, with the absorbance being<br>directly proportional to the concentration of Factor IX that was in<br>the sample. | | Device Intended Use: | The VisuLize™ Factor IX Antigen Kit is an Enzyme Immunoassay<br>for the quantitative determination of Factor IX Antigen in human<br>plasma samples and Factor IX concentrates using the double<br>antibody enzyme linked immuno-sorbent assay (ELISA). | {1}------------------------------------------------ ### Comparison to Predicate Device: | following table: | | | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | VisuLize™ Factor IX Antigen<br>Kit (Proposed Device) | Asserachrom IX:AG Kit<br>(Predicate Device) | | Assay Principle | Quantitative determination of Factor<br>IX antigen by sandwich ELISA<br>(polyclonal - polyclonal HRP) | Quantitative determination of Factor<br>IX antigen by sandwich ELISA<br>(polyclonal - polyclonal HRP) | | Intended Use | An enzyme immunoassay for the<br>quantitative determination of Factor<br>IX antigen in human plasma samples<br>and Factor IX concentrates using the<br>double antibody enzyme linked<br>immuno-sorbent assay (ELISA). | An enzyme immunoassay (EIA)<br>procedure for the quantitative<br>determination of Factor IX by the<br>sandwich technique also known as<br>enzyme-linked immunosorbent<br>assay (ELISA). | | Sample Matrix | Human plasma derived from blood<br>collected into 3.2% buffered citrate | Human plasma derived from blood<br>collected into 3.2% buffered citrate | | Intra-assay<br>precision (CV%) | 3.24% - 8.78% | 5.31% - 5.84% | | Inter-assay<br>precision (CV%) | 2.96% - 6.84% | 5.99% - 6.39% | | Linearity | Log-log curve, R2 ≥ 0.990 | Log-log graph | | Detection Limit | 0.005 IU/mL (0.5%) | 1% | | Traceability of<br>Calibrator Plasma | Calibrator plasma is standardized<br>against a secondary standard that is<br>traceable to the WHO International<br>Standard for Factor IX Activity<br>99/826 | Calibrator plasma is standardized<br>against a secondary standard that is<br>traceable to the WHO International<br>Standard for Factor IX Activity<br>99/826 | A technical comparison of the proposed device and the predicate device is illustrated in the ### Clinical Performance Comparison: The clinical performance of the VisuLize™ Factor IX Antigen Kit versus the Asserachrom IX:AG rine oliniour performance of the substantial equivalence. Testing of clinical samples across the kir was confider range was conducted internally and by two external testing sites. The results ohtained by the three testing sites demonstrated excellent correlations between the proposed and predicate devices, as illustrated in the following table: ### Summary of all Clinical Data from 3 Testing Sites | | INTERNAL<br>TESTING | EXTERNAL TESTING<br>SITE #1 | EXTERNAL TESTING<br>SITE #2 | |------------------------------------------------------------|---------------------|-----------------------------|-----------------------------| | Number of Samples | 134 | 114 | 109 | | Pearson Product<br>Moment correlation co-<br>efficient (r) | 0.987 | 0.976 | 0.982 | | P-value (Single factor<br>ANOVA) | 0.528 | 0.458 | 0.228 | Conclusion: Based on the technical comparison and clinical performance results, it is concluded that the VisuLize™ Factor IX Antigen kit is substantially equivalent to the Asserachrom IX:AG enzyme immunoassay. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. JUN 2 9 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Denise Foulon Scientific Director Affinity Biologicals Inc. 1395 Sandhill Drive Ancaster, ON Canada, L9G 4V5 Re: k051054 > Trade/Device Name: VisuLize™ Factor IX Antigen Kit Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GGP Dated: April 25, 2005 Received: April 26, 2005 Dear Ms. Foulon: 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). This letter will allow you to begin marketing your device as described in your Section 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. {3}------------------------------------------------ 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 (240) 276-0484. 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/industry/support/index.html Sincerely yours, Robert L. Becker Jr. Robert L. Becker, Jr., MD, PH. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Indications For Use Statement 510(k) Number (if known): K051054 Device Name: VisuLize™ Factor IX Antigen Kit Indications for Use: The VisuLize™ Factor IX Antigen Kit is intended for use as an in vitro diagnostic assay for the quantitative determination of Factor IX antigen in human plasma samples and Factor IX concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA). Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Souchesi Buntuta Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Kos1054