SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

{0}------------------------------------------------ 16 2099 ## 510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-7000 March 26, 2002 Dade Behring Inc. 13251 NW 9th Terrace Miami, FL 33182 Contact Person: Radames Riesgo at 305.480.7558 or by facsimile at 305.552.5288 JUN 2 7 2002 | Trade or Proprietary Name: Sysmex® Automated Coagulation Analyzer CA-7000 | | | | | | |----------------------------------------------------------------------------|--|--|--|--|--| |----------------------------------------------------------------------------|--|--|--|--|--| | Common or Usual Name: | Automated Coagulation System | | |-----------------------|--------------------------------------------------------------------------------------------|---------| | Classification Name: | Coagulation Instrument (21 CFR §864.5400) | | | Registration Number: | | | | | Manufacturing Site<br>Sysmex Corporation<br>Kobe, Japan | 9613959 | | | Importer<br>Sysmex Corporation of America<br>One Wildlife Way<br>Long Grove, IL 60047-9596 | 1422681 | | | Distributer<br>Dade Behring Inc.<br>Glasgow Site<br>P.O. Box 6101<br>Newark, DE 19714-6101 | 2517506 | The CA-7000 is substantially equivalent in intend use and technological characteristics to the Sysmex® Automated Coagulation Analyzer CA-6000, Sysmex Corporation, Kobe, Japan, which was cleared by FDA under Document Control Nos. K964139, K992321, K993174 and K001145; or the Behring Coagulation System (BCS™ System), Dade Behring, Marburg, Germany, which was cleared by FDA under Document Control Nos. K970431 and K000973. As demonstrated by clinical correlation studies, the performance claims of the proposed device are similar to the predicate devices. During those studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay. The following summaries show the results of the comparison studies between the proposed and the predicate devices as well as the results of of the precision studies performed with the CA-7000 analyzer. {1}------------------------------------------------ | Test | Predicate<br>Device | Sample<br>Number<br>(n) | Coefficient of<br>Correlation<br>(r) | Regression<br>Equitation | |-------------------------------------------------|---------------------|-------------------------|--------------------------------------|--------------------------| | Prothrombin Time<br>(Innovin®, seconds) | CA-6000 | 155 | 0.999 | Y = 0.97X + 0.38 | | Prothrombin Time<br>(Innovin®, INR) | CA-6000 | 155 | 0.999 | Y = 0.95X + 0.04 | | Prothrombin Time<br>(Thromborel® S, seconds) | BCS | 174 | 0.997 | Y = 1.09X - 1.54 | | Prothrombin Time<br>(Thromborel® S, % PT) | BCS | 168 | 0.984 | Y = 0.98X - 3.40 | | Derived Fibrinogen | CA-6000 | 104 | 0.991 | Y = 1.02X + 0.12 | | Activated Partial<br>Thromboplastin Time | CA-6000 | 151 | 0.997 | Y = 1.03X - 0.01 | | Fibrinogen (Clauss) | CA-6000 | 134 | 0.994 | Y = 0.91X + 0.05 | | Factor VII | BCS | 124 | 0.993 | Y = 1.14X - 2.66 | | Factor VIII | BCS | 143 | 0.977 | Y = 1.10X - 4.46 | | Protein C, coagulometric | BCS | 139 | 0.994 | Y = 1.14X - 4.77 | | Thrombin Time | CA-6000 | 381 | 0.981 | Y = 0.78X + 2.72 | | Batroxobin Time | BCS | 169 | 0.987 | Y = 1.02X + 0.75 | | Lupus Anticoagulant<br>LA1 Screening Reagent | CA-6000 | 136 | 0.996 | Y = 0.92X - 1.25 | | Lupus Anticoagulant<br>LA2 Confirmation Reagent | CA-6000 | 136 | 0.953 | Y = 0.66X + 10.59 | | Lupus Anticoagulant<br>LA1/LA2 Ratio | CA-6000 | 136 | 0.987 | Y = 1.00X - 0.08 | | Antithrombin III | BCS | 166 | 0.997 | Y = 0.96X - 1.07 | | Heparin, chromogenic | BCS | 115 | 0.982 | Y = 1.02X + 0.01 | | Plasminogen, chromogenic | BCS | 142 | 0.994 | Y = 0.96X + 0.55 | | a2- Antiplasmin,<br>chromogenic | BCS | 144 | 0.982 | Y = 0.95X + 3.18 | | Protein C, chromogenic | BCS | 156 | 0.996 | Y = 0.98X - 0.63 | | Factor VIII, chromogenic | BCS | 136 | 0.990 | Y = 1.10X - 1.52 | #### Summary of Method Comparison Studies Between CA-6000 or BCS - -- {2}------------------------------------------------ | Assay | Control Level | n | mean | Within<br>Run<br>%CV | Between<br>Run<br>%CV | Total<br>%CV | |---------------------------------------------------------------------------|-------------------------------------------------------------------|----------|---------------|----------------------|-----------------------|--------------| | Prothrombin Time | Control Plasma N | 40 | 11.9 | 0.4 | 0.2 | 0.4 | | (Dade® Innovin® Reagent, seconds) | Ci-Trol®Control Level3 | 40 | 37.2 | 0.5 | 2.0 | 2.1 | | Prothrombin Time | Control Plasma N | 40 | 1.1 | 0.4 | 0.2 | 0.4 | | (Dade® Innovin® Reagent, INR) | Ci-Trol®Control Level3 | 40 | 3.4 | 0.5 | 2.1 | 2.1 | | Prothrombin Time | Control Plasma N | 40 | 12.0 | 0.4 | 0.5 | 0.6 | | (Thromborel®S Reagent, seconds) | Control Plasma P | 40 | 25.1 | 0.9 | 1.1 | 1.4 | | Prothrombin Time | Control Plasma N | 40 | 91.9 | 0.6 | 0.6 | 0.8 | | (Thromborel®S Reagent, % of norm) | Control Plasma P | 40 | 36.1 | 1.0 | 1.2 | 1.5 | | Derived Fibrinogen | Control Plasma N | 40 | 1.9 | 5.4 | 2.2 | 5.5 | | (Dade® Innovin® Reagent, g/L) | Path. plasmapool | 40 | 5.7 | 3.2 | 1.3 | 3.3 | | Activated Partial Thromboplastin Time | Control Plasma N | 40 | 29.6 | 0.7 | 0.3 | 0.7 | | (Dade® Actin® FSL Reagent, seconds) | Ci-Trol®Control Level3 | 40 | 70.4 | 0.6 | 0.4 | 0.7 | | Fibrinogen (Clauss) | Control Plasma N | 40 | 2.5 | 1.4 | 0.7 | 1.5 | | (Dade® Thrombin Reagent, g/L) | Control Plasma P | 40 | 0.9 | 2.5 | 1.2 | 2.6 | | Factor VII | Control Plasma N | 40 | 99.7 | 2.4 | 3.4 | 4.1 | | (Dade® Innovin® Reagent) | Control Plasma P | 40 | 31.5 | 1.7 | 2.4 | 2.8 | | Factor VIII | Control Plasma N | 40 | 104.6 | 6.5 | 5.2 | 8.1 | | (Dade® Actin® FSL Reagent) | Control Plasma P | 40 | 33.8 | 5.9 | 3.9 | 6.8 | | Protein C Coagulometric | Control Plasma N | 40 | 112.5 | 3.2 | 1.2 | 3.2 | | (Portein C Reagent, % of norm) | Control Plasma P | 40 | 40.9 | 4.3 | 2.4 | 4.6 | | Thrombin Time | Control Plasma N | 40 | 16.5 | 0.6 | 1.1 | 1.3 | | (Test Thrombin Reagent, seconds) | Path. plasmapool | 40 | 19.7 | 3.5 | 4.4 | 5.5 | | Assay | Control Level | n | Mean | Within<br>Run<br>%CV | Between<br>Run<br>%CV | Total<br>%CV | | Batroxobin Time<br>(Batroxobin Reagent, seconds) | Control Plasma N<br>Path. plasmapool | 40<br>40 | 20.1<br>58.3 | 1.1<br>1.2 | 0.6<br>0.7 | 1.2<br>1.4 | | Lupus Anticoagulant<br>(LA1 Screening Reagent)<br>(seconds) | Control Plasma N<br>LA Control High | 40<br>40 | 36.1<br>90.6 | 1.6<br>1.5 | 2.7<br>1.5 | 3.1<br>2.1 | | Lupus Anticoagulant<br>(LA2 Confirmation Reagent)<br>(seconds) | Control Plasma N<br>LA Control High | 40<br>40 | 34.6<br>40.4 | 1.0<br>1.0 | 0.4<br>0.9 | 1.0<br>1.3 | | Lupus Anticoagulant<br>(LA1 / LA2)<br>(ratio) | Control Plasma N<br>LA Control High | 40<br>40 | 1.04<br>2.24 | 1.0<br>1.2 | 2.5<br>0.9 | 2.7<br>1.5 | | Antithrombin III<br>(Berichrom™ Antithrombin III (A)<br>Reagent) | Control Plasma N<br>Control Plasma P | 40<br>40 | 92.6<br>31.7 | 1.6<br>1.8 | 0.7<br>0.7 | 1.7<br>1.9 | | Heparin<br>(Berichrom™ Heparin Reagent) | Ci-Trol®Heparin<br>Control Low<br>Ci-Trol®Heparin<br>Control High | 40<br>40 | 0.06<br>0.22 | 7.3<br>1.9 | 6.1<br>2.1 | 9.2<br>2.8 | | Plasminogen<br>(Berichrom™ Plasminogen Reagent)<br>(% of norm) | Control Plasma N<br>Control Plasma P | 40<br>40 | 101.4<br>34.6 | 1.2<br>1.3 | 1.4<br>2.5 | 1.8<br>2.8 | | α2-Antiplasmin<br>(Berichrom™ α2-Antiplasmin<br>Reagent)<br>(% of norm) | Control Plasma N<br>Control Plasma P | 40<br>40 | 98.8<br>35.4 | 1.5<br>3.2 | 0.9<br>1.8 | 1.7<br>3.5 | | Protein C,<br>(Berichrom™ Protein C Reagent)<br>(% of norm) | Control Plasma N<br>Control Plasma P | 40<br>40 | 101.9<br>33.3 | 1.7<br>2.7 | 0.8<br>2.4 | 1.8<br>3.5 | | Factor VIII Chromogenic<br>(Factor VIII Chromogenic Assay)<br>(% of norm) | Control Plasma N<br>Control Plasma P | 40<br>40 | 107.5<br>29.6 | 1.7<br>1.4 | 3.8<br>2.4 | 4.2<br>2.8 | ### Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-7000 {3}------------------------------------------------ ( ## Summary of Precision Studies (Continued) Sysmex® Automated Coagulation Analyzer CA-7000 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUN 2 7 2002 Mr. Radames Riesgo Manager, Regulatory Affairs and Compliance Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, DE 19714-6101 Re: k020979 > Trade/Device Name: Sysmex® Automated Coagulation Analyzer CA-7000 Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: Class II Product Code: GKP Dated: June 21, 2002 Received: June 24, 2002 Dear Mr. Riesgo: 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ . . Page 2 - 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 1 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" (21CFR 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/dsmaldsmamain.html". Sincerely yours, Steven Butman 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 {6}------------------------------------------------ # 510(k) Number (if known): _ K O&O 979 Device Name: Sysmex® Automated Coagulation Analyzer CA-7000 #### Indications for Use: The intended use of the Sysmex® CA-7000 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument uses citrated human plasma to perform coagulation tests. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Josephine Bautista (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number - Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96)