ADVANCED D-DIMER ASSAY

{0}------------------------------------------------ # AUG 1 1 2004 ## 510(k) Summary for Advanced D-Dimer Assay 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 assigned 510(k) number is: _ Ko4 1438 ## Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation: Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany Contact Information: Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497 Preparation date: May 28, 2004 - Device Namel Classification: Advanced D-Dimer Assay 2. Fibrinogen and Fibrin Split Product, Class II, Class: 21 CFR 864.7320 Hematology (HE) Panel: DAP Product Code: ### Identification of the Legally Marketed Device: 3. Advanced D-Dimer Assay (K992957) #### Device Description: 4. Polystyrene particles covalently linked to a monoclonal antibody (DD5) to the crosslinkage region of cross-linked fibrin degradation products (D-dimer) are agglutinated when mixed with samples containing D-dimer. The cross-linkage region has a stereosymmetrical structure, i.e. the epitope for the monoclonal antibody occurs twice. Consequently, one antibody suffices in order to trigger an agglutination reaction, which is then detected turbidimetrically via the increase in turbidity. {1}------------------------------------------------ #### Device Intended Use: 5. Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative Advanced D Dimor is a fatox of handed and on products containing D-dimer in human determination of orders liching Coagulation Analyzers and Sysmex® Coagulation plasma for use with Dado Doning Oosay is intended for use as an aid in the diagnosis of Systems: The Auvanood ‫(VTE) Jdeep vein thrombosis (DVT) or pulmonary embolism (PE)]. ### Medical device to which equivalence is claimed and comparison information: 6. The modified Advanced D-Dimer assay is substantially equivalent in intended use to the The modified Advanced D-Dimer corrently marketed (K992957). The modified Advanced D-Dimer assay, like the current Advanced D-Dimer assay, is intended for the quantitative doody, like the ourrent interest tion products containing D-dimer in human determination of or order linked fining Coagulation Analyzers Sysmex Coagulation Systems. ### Device Performance Characteristics: 7. # Advanced D-Dimer Clinical Study Summary | 111111111111 11 11 11 1 2 1111 15 2 1011 11111 11 11 1 1 12 1011 11 111111<br>A Book Same Bear<br>washing more and | and and a province<br>108% 3-2 1 4 hours and 11 8 2 4 1 4 5 3 4 1 1 7 3 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | . | A BAND BE PART<br>A C R C S . C . S.<br>2017 28 | | STORES OF COLLECTION<br>173 2008 200 | |--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | BCS"<br>System | 000<br>SIL | | છેકે | 38 | ਰੇਰੇ | | A-1500<br>Sysmex | 297 | | 100 | l Children Children Children Children Children Children Station of Children Children Station of Children Station of Children Station of Children Station of Children Station o<br>ﺮ | 100 | {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Druq Administration 2098 Gaither Road Rockville MD 20850 Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714 AUG 1 1 2004 k041438 Re: Trade/Device Name: Advance D-Dimer Assay Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen/Fibrin degradation products assay Regulatory Class: II Product Code: DAP Dated: May 28, 2004 Received: June 2, 2004 Dear Ms. Dray-Lyons: 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 for use stated in the enerest. 976 the enactment date of the Medical Device Amendments, or to conniner or prist to ria) 2011-03-2014 in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmeter For (110) that the device, subject to the general controls provisions of the Act. The r ou may, merelove, mainer of the Act include requirements for annual registration, listing of general controls provision 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 If your do rioe is excerined controls. Existing major regulations affecting your device can may or sabyer to basil at basil at the material 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 r toate be acternination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any vith 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 Of it rate of 7, as the g requirements o 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, rr you destre specific movies and advertising of your device, please contact the Office of In of questions on the promise Evaluation and Safety at (301) 594-3084. Also, please note the v Hro Diagnetitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation other general information on your responsibilities under the Act from the Four inay 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, Robert L. Becker Jr. Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K041438 Device Name: Advanced D-Dimer Indications For Use: Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative A lovernination of cross-linked fibrin degradation products containing D-dimer in human plasma for use with Dade Behring Coagulation Analyzes and Sysmex® Coagulation plasma for ass war Daal D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Mana Chan for Josephine Bautista Division Sign-Off Page 1 of ____________________________________________________________________________________________________________________________________________________________________ Office of In Vitro Diagnomic Device Evaluation and sty 510(k) K041438