VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG

{0}------------------------------------------------ K052825 ## Section H JAN 2 0 2006 # 510(k) Summary for VisuLize™ Factor VIII Antigen Kit (Summary of Safety and Effectiveness) This summary of 510(k) safety and effectiveness information is being sumitted in Sammary of UTS(x) Carolyiirements 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: | September 30, 2005 | | Name of the Device: | VisuLize™ Factor VIII Antigen Kit<br>Common Name: Factor VIII 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: | Coamatic® Factor VIII, K981038<br>Instrumentation Laboratory Co. | | Device Description: | The VisuLize™ Factor VIII 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 VIII.<br>A chromogenic substrate (TMB) is added to allow for color<br>development. The color formed is measured<br>spectrophotometrically at 450 nm, with the absorbance being<br>directly proportional to the concentration of Factor VIII that was in<br>the sample. | | Device Intended Use: | The VisuLize™ Factor VIII Antigen Kit is an Enzyme<br>Immunoassay for the quantitative determination of Factor VIII<br>Antigen in human plasma samples and Factor VIII concentrates<br>using the double antibody enzyme linked immuno-sorbent assay<br>(ELISA) | {1}------------------------------------------------ #### Comparison to Predicate Device: A technical comparison of the proposed device and the predicate device is illustrated in the following table: | | VisuLize™ Factor VIII Antigen Kit<br>(Proposed Device) | Coamatic Factor VIII assay<br>(Predicate Device) | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Assay Principle | Quantitative determination (in IU/mL) of Factor VIII antigen by sandwich ELISA (polyclonal - polyclonal HRP) | Quantitative determination (in IU/mL) of Factor VIII activity by Factor Xa chromogenic activity assay. | | Intended Use | An enzyme immunoassay for the quantitative determination of Factor VIII antigen in human plasma samples and Factor VIII concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA). | For the photometric determination of factor VIII activity in plasma such as when identifying factor VIII deficiency or monitoring patients on replacement therapy as well as for potency estimation of FVIII concentrates. | | Technology | Double antibody enzyme linked immuno-sorbent assay (ELISA) | Chromogenic based assay | | Sample Matrix | Human plasma derived from blood collected into 3.2% buffered citrate | Human plasma derived from blood (9 vol blood mixed with 1 vol 0.1mol/L citrate) | | Intra-assay precision (CV%) | 2.97 – 6.77%<br>(mean results) | 2.4 – 3.0% | | Inter-assay precision (CV%) | 3.38 – 6.66%<br>(mean results) | 2.1 – 5.9% | | Linearity | Log-log curve, R2 $\geq$ 0.990 | Linear curve | | Detection Limit | 0.008 IU/mL (0.8%) | Normal range: 0.05 IU/mL<br>Low range: 0.005 IU/mL | | Traceability of Calibrator Plasma | Calibrator plasma is standardized against a secondary standard that is traceable to the WHO International Standard for Factor VIII Antigen | Not provided with kit. | The technological difference between the 2 devices does not raise concerns regarding safety and effectiveness as the ELISA method is a well-characterized technology. Secondly, the performance evaluation carried out on the proposed device further supports its safety and effectiveness. #### Clinical Performance Comparison: The clinical performance of the VisuLize™ Factor VIII Antigen Kit versus the Coamatic® Factor VIII assay was compared to demonstrate substantial equivalence. Testing of clinical samples across the entire detection range was conducted internally and by two external testing sites. The results obtained 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<br>TESTING SITE #1 | EXTERNAL<br>TESTING SITE #2 | |--------------------------------------------------------|---------------------|-----------------------------|-----------------------------| | Number of Samples | 142 | 100 | 81 | | Pearson Product Moment<br>correlation co-efficient (r) | 0.968 | 0.964 | 0.974 | Conclusion: Based on the technical comparison and clinical performance results, it is concluded that the VisuLize™ Factor VIII Antigen kit is substantially equivalent to the Coamatic® Factor VIII assay. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Denise Foulon Scientific Director Affinity Biologicals, Inc. 1395 Sandhill Drive Ancaster, Ontario Canada, L9G 4V5 JAN 2 0 2006 k052825 Re: Trade/Device Name: VisuLize™ Factor VIII Antigen Kit Regulation Number: 21 CFR§ 864.7290 Regulation Name: Factor deficiency test Regulatory Class: Class II Product Code: GGP Dated: December 5, 2005 Received: December 6, 2005 Dear: Ms. Foulon We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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). and Coometer For , 100) known 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, n you stions 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 I va may ovailable ground of 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, lobatz Beckeyh Robert L. Becker, Jr., MD, PK 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): K0538875 Device Name: VisuLize™ Factor VIII Antigen Kit #### Indications for Use: The VisuLize™ Factor VIII Antigen Kit is intended for use as an in vitro diagnostic assay The Visuelize - Factor VIII antigen in human plasma samples and for the quantiative dolormination United antibody enzyme linked immuno-sorbent assay (ELISA). Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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) Caroline Buatulai **Division Sign-Off** Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K052825 510(k) VisuLize™ Factor VIII Antigen Kit, RAR0026 rev. 1