(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT

{0}------------------------------------------------ ## MAR 2 8 2000 Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850 November, 1999 # 510(k) Summary of Safety and Effectiveness Information This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The assigned 510(k) number is K994194. | Submitted by: | Cynthia Pritchard, Ph.D. (author)<br>Cardiovascular Diagnostics, Inc. | |------------------|-----------------------------------------------------------------------| | Address: | 5301 Departure Drive<br>Raleigh, NC 27616 | | Phone: | 1-800-247-4234 | | Fax: | 1-919-954-9932 | | Contact: | Peter Scott<br>VP of Quality Assurance and Regulatory Affairs | | Date of Summary: | November, 1999 | {1}------------------------------------------------ Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850 November, 1999 ### Summary of Safety and Effectiveness Information LHMT Card Trade name: (Rapidpoint Low range Heparin Management Test) Common Name: LHMT Classification Name: systems for in vitro coagulation studies, automated or semiautomated instruments and associated reagents and controls used to perform a series of coagulation studies and coagulation factor assays (Class II. 21 CFR864.5425) Predicate Device: The proposed Rapidpoint LHMT is substantially equivalent to the recently cleared to market Low Range Activated Clotting Time test (ACT-LR; International Technidyne Corporation), performed on the Hemochron Jr. and the Activated Clotting Time test (ACT; International Technidyne Corporation), performed on the Hemochron. These devices produce similar results with samples from patients on low to moderate doses of heparin (see package insert for predicate devices). Description of the Device: The Rapidpoint LHMT provides a method to measure the response of a patient to heparin. A noncitrated whole blood sample can be used for this test. The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample flows into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time. Intended Use: The Rapidpoint Low range Heparin Management Test Card is to be used with the Rapidpoint Coag (formerly TAS) Analyzer to monitor the effects of low to moderate levels of unfractionated heparin on coagulation in noncitrated arterial whole blood samples from patients undergoing diagnostic and interventional procedures. The test is for in vitro diagnostic use. It is especially suited for professional use in decentralized areas of the hospital near the patient's bedside, in the cardiac catheterization lab, and other areas where patients are treated with low to moderate levels of heparin. LHMT Cards {2}------------------------------------------------ Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850 November, 1999 and the control of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comment ### Summary of Safety and Effectiveness Information LHMT Card ### Comparison of Rapidpoint LHMT and the Predicate Device(s) ### Hemochron ACT-LR or ACT (International Technidyne) | Characteristic | Predicate Device | Proposed Device | |---------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Intended Use | monitors effect of heparin at low<br>to moderate doses | same | | Format | dry reagent in cuvette or tube | lyophilized reagents in a flat<br>shallow reaction chamber<br>mounted on a thin plastic card | | Reaction | one stage | one stage | | Sample type | noncitrated whole blood | citrated or noncitrated whole<br>blood | | Reagent base | Celite (ACT), celite, potato<br>dextrin (ACT-LR) | celite, partial thromboplastin | | Reaction | formation of a fibrin clot | same | | Instrument | Hemochron Jr., Hemochron 401 | Rapidpoint Analyzer | | Endpoint monitored | coagulation time | same | | Units reported | Seconds | same | | Test interpretation | endpoint has direct correlation to<br>heparin activity | same | | Range | Up to 2.5 U/ml (ACT-LR) or 6<br>U/ml (ACT) of heparin | 0 - 3 Units of heparin | | Quality control | functional testing with two levels<br>of quality control plasmas,<br>electronic QC | Same and self tests performed by<br>analyzer at power up and<br>throughout operation | LHMT Cards {3}------------------------------------------------ Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------November, 1999 10 - 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 ### Summary of Safety and Effectiveness Information LHMT Card ### Stachrom Heparin (anti-Xa; Diagnostica Stago) (reference, tiebreaker method) ' | Characteristic | Reference Test | Proposed Device | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | determines heparin concentration | monitors effect of heparin at low to moderate doses | | Format | chromogenic assay | lyophilized reagents in a flat shallow reaction chamber mounted on a thin plastic card | | Reaction | two stage chemical | one stage coagulation | | Sample type | plasma | noncitrated whole blood | | Reagent base | antithrombin (AT), Xa, chromogenic substrate | celite, partial thromboplastin | | Reaction | heparin in the sample combines with AT to inactivate Xa; remaining Xa catalyzes release of p-nitroaniline from the substrate; absorbance is inversely proportional to heparin level | formation of a fibrin clot | | Instrument | MDA, Organon Teknika | Rapidpoint Coag analyzer, CVDI | | Endpoint monitored | colorimetric reaction; absorbance at 405 nm | coagulation time | | Test interpretation | heparin concentration | endpoint has direct correlation to heparin activity | | Quality control | standards run with each set of assays | self tests performed by analyzer at power up and throughout operation, plus functional testing of each test card with two levels of quality control plasmas, electronic QC | Nonclinical Performance Data: Preclinical testing was done at CDI using Rapidpoint LHMT cards and the Rapidpoint Coag analyzer to determine the performance characteristics of the system. The Rapidpoint L.HMT cards are stable at refrigerator temperatures or lower (<8℃) for a period of time up to or exceeding the expiration date recorded on the cards. The LHMT is sensitive to the effects of heparin on coagulation, and responds in a linear manner from 0 to 3.0 Ulml of heparin. The LHMT card is relatively insensitive to deficiencies in the intrinsic and common coagulation pathways, as expected. Lipid (to at least 15 mg/ml), nitroglycerin (to 1 ug/ml), and Dextran (to 6 mg/ml) had no effect on LHMT card results in the presence of absence of heparin. There was no effect of sample temperature (2 - 37°C) on LHMT card results. LHMT Cards {4}------------------------------------------------ Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850 November, 1999 Clinical Performance Data: Noncitrated samples were obtained from 59 males and 61 females that were normal, healthy donors, ranging in age from 24 to 67 years. Normal ranges (mean +/- 2 SD) were 65 to 175 for noncitrated whole blood. Field testing and clinical testing were done at large hospitals to establish substantial equivalence of the Rapidpoint LHMT to the predicate devices (ACT or ACT-LR). The range with noncitrated patient "baseline" samples taken before the procedures were begun was 53 to 195 seconds. Samples also were taken from individuals expected to have abnormal LHMT results and were tested to compare results of the LHMT cards, the predicate device, and a chromogenic anti Xa assay for heparin activity. A total of 429 samples were drawn from 232 individuals undergoing a variety of treatments. These samples were tested on several different lots of LHMT cards on the Rapidpoint Coag Analyzer and with the predicated device. Noncitrated samples from all sites combined produced an overall correlation of 0.93 of the LHMT card to the ACT. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The image is simple and straightforward, with a clear focus on the text. MAR 2 8 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Peter Scott Vice President, Quality Assurance and Regulatory Affairs Cardiovascular Diagnostic, Inc. 5301 Departure Drive Raleigh, North Carolina 27616 Re: K994194 > Trade Name: Cardiovascular Diagnostics Rapidpoint Coag ( TAS) Low range Heparin Management Test (I.HMT ) Card Regulatory Class: II Product Code: JBP Dated: March 14, 2000 Received: March 15, 2000 Dear Mr. Scott: 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 generals, 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 cither 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 notes 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 Flectronic Product Radiation Control provisions, or other Federal laws or regulations. {6}------------------------------------------------ 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 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 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 {7}------------------------------------------------ Page 1 of 1 510(k) Number (if known): K994194 Device Name: Low range Heparin Management Test (LHMT) Card Indications For Use: The Rapidpoint Coag Low range Heparin Management Test Card is to be used with the Rapidpoint Coag Analyzer to monitor the effects of low to moderate levels of unfractionated heparin on coagulation in noncitrated arterial whole blood samples from patients undergoing diagnostic and interventional procedures. The test is for in vitro diagnostic use. It is especially suited for professional use in decentralized areas of the hospital near the patient's bedside, in the cardiac catheterization lab, and other areas where patients are treated with low to moderate levels of heparin. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Tuta E. Maluni (Optional Format 3-10-98) FESSERIPANON -