MODIFICATION TO COATEST FACTOR VIII

{0}------------------------------------------------ K033631 (5 DEC 1 5 2003 ## Section 3 Coatest Factor VIII 510(k) Summary (Summary of Safety and Effectiveness) ### Submitted by: Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207 ### Contact Person: Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207 ### Summary Prepared: November 18, 2003 ### Name of the Device: Coatest Factor VIII (Modified) ### Classification Name: | 864.7290 | Factor Deficiency Test | Class II | |----------|------------------------------------------------------|----------| | 81GGP | Test, Qualitative and Quantitative Factor Deficiency | | ### Identification of predicate device: K833892 Coatest Factor VII ## Description of the modified device: Coatest Factor VIII (K833892) was modified to substitute the natural porcine phospholipids in the Phospholipid reagent with synthetic phospholipids. This modification does not alter the fundamental scientific technology of the device or its intended use for the photometric determination of Factor VIII activity in citrated plasma. # Statement of Technological Characteristics of the Device Compared to Predicate Device: The modified Coatest Factor VIII is substantially equivalent in performance, intended use, safety and effectiveness to the currently marketed Coatest Factor VIII. ## Summary of Performance Data: Within run and between run precision assessed over multiple runs in the low and high ranges using two levels of control plasma gave the results below: | Range | Control Level | n | Mean<br>% FVIII | Within Run<br>%CV | Between Run<br>%CV | |-------|---------------|----|-----------------|-------------------|--------------------| | Low | Low | 90 | 14.4 | 1.5 | 2.3 | | High | Normal | 89 | 81.8 | 1.4 | 2.4 | The following results were obtained in a method comparing the current legally marketed Coatest Factor VIII to the modified Coated Factor VIII: | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | الموال<br> | CALL CLASS COLLECT A<br>Intercept | | As all all of the store and the first the first the figure of the film to the collection of the film of the collection and the comments of the results of the second the secon<br>Sample Range | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------------------|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. 20<br>Special and the first and the company of the company of the company of the company of the company of the company of the company of the company of the company of the company o | 1.002 | 0.365 | 0 085<br>100 000 | Californial<br>. 47 % EVET<br>1 | {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 1 5 2003 Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, MA 02421-3125 Re: k033631 > Trade/Device Name: Coatest Factor VIII (Modified) Regulation Number: 21 CFR 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: Class II Product Code: GGP Dated: November 18, 2003 Received: November 19, 2003 Dear Ms. Marble: 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 - 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. 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). Other general information on your responsibilities under the Act may be obtained 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, Steven Sutman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Statement **510(k) Number (if known):** K033631 Device Name: Coatest Factor VIII (Modified) # Indications for Use: Coatest Factor VIII was modified to substitute the natural porcine phospholipids in the Phospholipid reagent with synthetic phospholipids. This modification does not alter the fundamental scientific technology of the device or its intended use for the photometric determination of Factor VIII activity in citrated plasma. For in vitro diagnostic use. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--| | Division Sign-Off | | | Office of In Vitro Diagnostic Device | | Evaluation and Salety 510(k) K033631 Prescription Use (Per 21 CFR 801.019) Over-The-Counter Use Section 2 Special 510(k): Coatest Factor VIII OR Page 1 of 1