DADE BEHRING BFTII

{0}------------------------------------------------ Dade Behring Inc. Dade Behring BFTII 510(k) Notification 84501 JUL 28 1999 ### 510(k) Summary For Dade Behring BFTII ### Manufactures Name, Address, Telephone, and Contact Person, Date of 1. Preparation: Manufacturer: Contact Information: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Rebecca S. Ayash Tel: 302-631-6276 Preparation date: June 29, 1999 #### 2. Device Name/ Classification: Dade Behring Fibrintimer II (BFTII): Classification Number: Multipurpose system for in vitro coagulation studies Class II (864.5425) #### 3. Identification of the Legally Marketed Device: Behring Coagulation Timer & CA-6000 #### 4. Device Description: Dade Behring BFTII is a semi-automated opto-mechanical coagulation analyzer. The BFTII is used in conjunction with coagulation reagents for measurement of various coagulometric tests. #### 5. Device Intended Use: The Dade Behring Fibrintimer II (BFTII) is a semi-automated device intended for use to determine PT, aPTT, and Fibrinogen. #### 6. Medical device to which equivalence is claimed and comparison information: There are a number of multipurpose systems for in vitro coagulation studies. Two such products are the Dade Behring BCT, K955278 and CA-6000, K964139. The BFTII is substantially equivalent in intended use and results obtained to both the BCT and CA-6000. The BFTII, like the BCT and CA-6000, performs quantitative measurement of coagulometric tests by optical clot detection. 000019 {1}------------------------------------------------ Image /page/1/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. Above the caduceus, the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern. The text is in all caps and appears to be in a sans-serif font. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUL 28 1999 Ms. Rebecca S. Ayash Manager, Regulatory and Biology Dade Behring, Inc. Glasgow Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101 Re: K984501 Trade Name: Dade Behring BFTII Regulatory Class: II Product Code: JPA Dated: May 12, 1998 Received: May 13, 1998 Dear Ms. Ayash: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Dade Behring Inc. Dade Behring BFTII 510(k) Notification ## Indications Statement Device Name: Dade Behring BFTII ### Indications for Use: The Dade Behring BFTII is a semi-automated device intended for use to determine PT, a nd and will to aPTT, and Fibrinogen. Peter E. Machin (Dion S. Di of ratory Devices K984501 510(k) Number (Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use_ (Optional Format 1-2-96) # 000018