CS-400 COAGULATION ANALYZER SYSTEM (A1208)

{0}------------------------------------------------ # 000 20 1997 #### 510(k) NOTIFICATION Sigma Diagnostics Inc. June 12, 1997 2019 CS-400™ Coagulation Analyzer Catalog No. A1208 #### 510(k) Summary of Safety and Effectiveness The Amelung CS-400™ Coagulation Analyzer is an automated random access multipurpose analyzer. The CS-400™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the CS-400™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III). In comparison studies of assays between the CS-400™ Coagulation Analyzer and the Amelung AMAX CS-190™ Coagulation Analyzer, the following regression statistics were obtained: | PT (optical) | r = 0.921 | y = 1.061x + 0.6 | |-------------------------|-----------|-------------------| | PT (mechanical) | r = 0.924 | y = 1.038x - 0.5 | | APTT (optical) | r = 0.964 | y = 1.072x - 0.5 | | APTT (mechanical) | r = 0.972 | y = 0.938x + 1.0 | | Factor IX (optical) | r = 0.945 | y = 0.943x + 4.6 | | Factor IX (mechanical) | r = 0.924 | y = 0.977x + 3.7 | | Factor X (optical) | r = 0.966 | y = 0.920x + 9.5 | | Factor X (mechanical) | r = 0.974 | y = 0.898x + 8.7 | | Fibrinogen (optical) | r = 0.967 | y = 1.064x - 11.3 | | Fibrinogen (mechanical) | r = 0.977 | y = 1.074x - 2.2 | | AT III (chromogenic) | r = 0.972 | y = 0.920x + 11.7 | The following coefficients of variation were obtained from precision studies: | | Within Run | Total | |-------------------------|------------|-------| | PT (optical) | <2.2% | <4.5% | | PT (mechanical) | <3.2% | <6.5% | | APTT (optical) | <2.5% | <3.5% | | APTT (mechanical) | <2.3% | <3.5% | | Factor IX (optical) | <5.3% | <7.3% | | Factor IX (mechanical) | <6.3% | <9.5% | | Factor X (optical) | <5.7% | <7.8% | | Factor X (mechanical) | <3.8% | <7.0% | | Fibrinogen (optical) | <5.1% | <8.1% | | Fibrinogen (mechanical) | <5.9% | <9.0% | | AT III (chromogenic) | <5.9% | <9.3% | The safety and effectiveness of the CS-400™ Coagulation Analyzer is demonstrated by its substantial equivalency to the predicate devices. {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human figures intertwined, representing health and well-being. The logo is presented in black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 ### OCT 20 1997 William Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics Inc. 545 South Ewing Avenue St. Louis, Missouri 63103 K972260 Re : CS-400™ Coaqulation Analyzer System Requlatory Class: II Product Code: JPA Dated: Auqust 21, 1997 Received: August 22, 1997 Dear Dr. Gilbert: 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 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 The general controls provisions of the Act 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 Requlations, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 requlations. {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 requlation (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 Other general premarket notification" (21 CFR 807.97). 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/dsmamain.html". Sincerely yours, Steven Gutman 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}------------------------------------------------ Page 1 of 1 510(k) Number (if known): _ Device Name: CS-400™ Coagulation Analyzer ## Indications For Use: The CS-400™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ### Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory Devices) 510(k) Number. K972260 Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use \$\eta\$