HEMOCHRON RESPONSE/SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the letters "ITC" in a bold, sans-serif font. The letters are black and are slanted to the right. The letters are large and take up most of the image. The image is simple and has a white background. Image /page/0/Picture/1 description: The image shows a handwritten or stamped date. The top line reads "K0308/8". The second line reads "APR 02 2003". The date appears to be April 2, 2003. ### 510 (k) Summary #### HEMOCHRON® Response Instrument/System March 13, 2003 Prepared: Submitted by: John Clay International Technidyne Corp. 6 Olsen Ave. Edison, NJ 08820 (732-548-5700) Ext. 265 (732-548-2325) Fax This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. #### Device Name | Common / Usual Name: | Whole Blood Coagulation Test System | |----------------------|---------------------------------------| | Product Name: | HEMOCHRON® Response Instrument/System | #### Predicate Device HEMOCHRON® Response (K983475) #### Device Description The Hemochron Response instrument/system described herein is a software upgrade (Version 2.0) to the current Hemochron Response Instrument, which has been cleared under K983475 (May 1999). The HEMOCHRON® Response is a portable, dual-well microprocessor-controlled coagulation instrument with an integral barcode reader, laboratory communication interface and a printer designed to perform whole blood coagulation tests using fresh or citrated whole blood. The system is intended for use in many clinical settings requiring point-of-care testing. The modified Response instrument performs the same assays as the predicate instrument. There are no changes to the clot detection algorithm. The patented clot detection mechanism is an electro-mechanical system consisting of two test wells into which disposable test tube assays are inserted. The test tube assays contain specific reagent for the test performed and a precision magnet. Immediately after adding a blood sample to the test tube and pressing the start button, the test tube is placed in the test well and is automatically rotated at a slow controlled speed and incubated at 37°C. When a fibrin clot begins to form, it causes the magnet in the test tube to be displaced. Two magnetic detectors located in the test well continuously monitor the precise position of the magnet. When a pre-determined displacement occurs, the elapsed time form the start of the test and the clot endpoint is displayed as the coagulation time in seconds. {1}------------------------------------------------ The HEMOCHRON® Response contains extensive data management capabilities including the following: - Patient and quality control result storage - . Input of operator and patient identification - Designation of quality control level ● - Date and time stamp for all test results . - Printing of results - . Tagging of test results with date and time - Operator Lockout ● - Storage of operator identification numbers . - . Downloading of stored patient and OC data to a PC - Configurable date and time formats ### New Features of the Hemochron Response Instrument The modifications to the Hemochron Response instrument include a software revision to the instrument. The major components of the software modification include the following: - . Activation of the automated heparin and protamine dosing calculations for patient management. This system is the RxDx module and is described in a previous submission (K010193) for the Hemochron Kaolin-Activated heparin and protamine dosing assays. - Enhanced programming capability and flexibility for the user through the use of the . instrument keypad and the Hemochron Response Data Management Software (HRDM), which is provided for use in a personal computer (PC). The use of the Hemochron Response Data Management Software has been described in the predicate device submission and operator's manual (K983475). The user interface for the clinician remains consistent with the previously cleared system with the exception of the enhanced features described in the revised operators manual, the RxDx module and the features associated with the (HRDM). ### Statement of Intended Use The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays for In vitro diagnostic use only. Activated Clotting Time (ACT) - All HEMOCHRON types Activated Partial Thromboplastin Time (APTT) - All HEMOCHRON types Prothrombin Time (PT) - All HEMOCHRON types Thrombin Time (TT) Heparin Neutralized Thrombin Time (HNTT) High Dose Thrombin Time (HiTT) Fibrinogen (FIB) Protamine Dose Assay (PDA) - All HEMOCHRON types Heparin Response Time (HRT) - All HEMOCHRON types Protamine Response Time (PRT) - All HEMOCHRON types {2}------------------------------------------------ #### Summary of Performance Data #### Laboratory Correlations Laboratory correlation studies were conducted between the Hemochron Response V1.52 (Current Version) and Hemochron Response V2.00 (Modified Version) instruments using a split sample design. Heparin sensitivity testing was conducted on the test tubes from each of three groups of tests, namely ACT (including ACT, KACT and P214), specialty tubes (including APTT FWB, APTT Citrate, PT FWB, PT Citrate, TT, HNTT, Fibrinogen diluted and undiluted) and RxDx tubes (including HRTB, HRTP, PDAO, PRT200, each in Celite or kaolin versions). Blood samples were drawn from four different donors and heparinized in vitro. Six HR V2.00 and six HR V1.52 were used for these laboratory studies. > The linear correlations between the instruments were excellent. (Y=HR V2.00, X=HR V1.52) HR=Hemochron Response | Test Assay Group | Correlation Equation | r value | n | |------------------|----------------------|---------|----| | ACT Tubes | $y=0.98x-9.36$ | 0.995 | 18 | | Specialty Tubes | $y=1.04x-0.45$ | 0.954 | 15 | | RxDx Tubes | $y=1.00x-16.32$ | 0.998 | 17 | #### Precision Testing Precision testing was conducted using two levels of assay-specific controls on two Response V 1.52 and two Response V2.00 (n=10 per instrument type) instruments. Representative assays from each of three groups of tests including ACT (ACT test tubes), APTT Fresh Whole Blood, HiTT (Specialty test tubes) and PRT (RxDx test tubes) were used in the test matrix. | Level 1 | HR V2.00 | HR V1.52 | Level 2 | HR V2.00 | HR V1.52 | |------------|----------|----------|------------|----------|----------| | total mean | 127.5 | 130.8 | total mean | 269.3 | 261.8 | | SD | 7.6 | 8.1 | SD | 13.8 | 9.0 | | CV% | 6.0% | 6.2% | CV% | 5.1% | 3.4% | | mean diff | 2.52% | | mean diff | 2.86% | | d. CDI Na ారా (Control ### Assay: APTT FWB (Control used: O101 Normal and Abnormal) | Level : | HR V2.00 | HR V 1.52 | Level 2 | HR V2.00 | HR V1.52 | | |------------|----------|-----------|------------|----------|----------|--| | total mean | 103.5 | 106.6 | total mean | 335.6 | 321.9 | | | SD | 7.8 | 9.1 | SD | 17.9 | 16.9 | | | CV% | 7.5% | 8.5% | CV% | 5.3% | 5.2% | | | mean diff | 2.91% | | mean diff | | 4.26% | | {3}------------------------------------------------ | Assay: PRT | (Control used: RxDX WBC Normal and PRT Level II) | | | | | |------------|--------------------------------------------------|----------|------------|----------|----------| | Level 1 | HR V2.00 | HR V1.52 | Level 2 | HR V2.00 | HR V1.52 | | total mean | 151.8 | 156.5 | total mean | 359.5 | 376.4 | | SD | 7.7 | 8.8 | SD | 14.9 | 10.3 | | CV% | 5.1% | 5.6% | CV% | 4.2% | 2.7% | | mean diff | 3.51% | | mean diff | 4.49% | | #### Assav: PRT (Control used: PxDx WRC Normal and PPT Lavel II) #### Assay: HiTT (Control used: RxDx WBC Normal and HiTT Level II) | Level 1 | HR V2.00 | HR V1.52 | Level 2 | HR V2.00 | HR V1.52 | | |------------|----------|---------------------|------------|----------|----------|--| | total mean | 57.1 | રેતે રહ્યું રેતા વિ | total mean | 168.6 | 183.9 | | | SD | 8.2 | 8.0 | SD | 26.4 | 24.0 | | | CV% | 14.4% | 13.5% | CV% | 15.7% | 13.0% | | | mean diff | 4.19% | | mean diff | 8.32% | | | | | | | | | | | ## Conclusion of Risk analysis and Design Controls Based on the extensive verification and validation testing, it can be concluded that the potential risks associated with the modified system have been resolved and that safety and effectiveness of the HEMOCHRON Response Instrument/System are not compromised. {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol with three intertwined lines, representing health and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. John Clay Director, Regulatory Affairs International Technidyne Corporation 8 Olsen Avenue Edison, New Jersey 08820 Re: k030818 > Trade/Device Name: HEMOCHRON® Response Instrument/System Regulation Number: 21 CFR & 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Instruments Regulatory Class: II Product Code: JPA Dated: March 13. 2003 Received: March 14, 2003 APR 0 2 2003 Dear Mr. Clay: 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. Iisting 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). 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. {5}------------------------------------------------ Page 2 - 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). You may obtain other general information on your responsibilities under the Act 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 {6}------------------------------------------------ # 510(k) Number (If Known): Device name: HEMOCHRON® Response #### Indications for Use: The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays Activated Clotting Time (ACT) - All HEMOCHRON types Activated Partial Thromboplastin Time (APTT) - All HEMOCHRON types Prothrombin Time (PT) - All HEMOCHRON types Thrombin Time (TT) Heparin Neutralized Thrombin Time (HNTT) High Dose Thrombin Time (HiTT) Fibrinogen (FIB) Protamine Dose Assay (PDA) - All HEMOCHRON types Heparin Response Time (HRT) - All HEMOCHRON types Protamine Response Time (PRT) - All HEMOCHRON types For In Vitro Diagnostic Use Only 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 K030818 Prescription Use or Over-the- Counter Use Per 21 CFR 801.109 (Optional Format 1-2-96)