GBACT + KIT

{0}------------------------------------------------ #### MAY 28 1000 Sienco, Inc. 4892 Van Gordon St. - Unit 203 Wheat Ridge, CO USA 80033 303/420-2204(Fax) 303/420-1148 800/432-1624 # 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: _K 984 141 - (1) Contact Person: Barbara DeBiase, Director, Sienco Inc. Summary Preparation Date: 1 November 1998 - (2) Device Trade Name: gbACT+ Kit Common Name: Activated Clotting Time (ACT) Test Classification Name: Activate Whole Blood Clotting Time Test Classification: Class II, 21 CFR 864.7140 - (3) Identification of predicate device to which substantial equivalence is being claimed: SonACT Kit, 510(k) # K952560 - (4) and (5) Device Description and Intended Use: The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. Each kit contains glass bead cuvettes, probes and instructions for use. Current package sizes of 100 (#800-0412) and 24 (#800-0411) tests are available. The lidded pink cuvettes contain a controlled amount of the glass bead activator and a magnetic stir bar. A mason box is used for the kit package. The gbACT+ test is an activated whole blood clotting time test. It may also be used with citrated whole blood or plasma. The gbACT+ Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management at low to moderate heparin levels (1 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. . " {1}------------------------------------------------ #### (6) Technological Characteristic Comparison of the gbACT+ Kit to the standard SonACT Kit: | ITEM | gbACT+ | STANDARD SONACT | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Name | Activated Whole Blood Clotting<br>Time Test | Activated Whole Blood Clotting<br>Time Test | | IVD Reagent for<br>Use With | Sonoclot Coagulation & Platelet<br>Function Analyzer | Sonoclot Coagulation & Platelet<br>Function Analyzer | | Intended Use | General purpose global hemostasis<br>monitoring, hypercoagulable and<br>hyperfibrinolysis screening,<br>platelet function assessment,<br>anticoagulation management (low<br>to moderate heparin levels) | General purpose global hemostasis<br>monitoring, hypercoagulable and<br>hyperfibrinolysis screening,<br>platelet function assessment,<br>anticoagulation management (low<br>to high heparin levels) | | Results Provided | Quantitative results for Activated<br>Clotting Time (Onset /ACT Time).<br>Qualitative and quantitative fibrin<br>formation information (Clot RATE,<br>Sonoclot Signature). Qualitative<br>and quantitative platelet function<br>information from Sonoclot<br>Signature. Qualitative and<br>quantitative hyperfibrinolysis<br>information from Sonoclot<br>Signature. | Quantitative results for Activated<br>Clotting Time (Onset/ACT Time).<br>Qualitative and quantitative fibrin<br>formation information (Clot RATE<br>Sonoclot Signature). Qualitative<br>and quantitative platelet function<br>information from Sonoclot<br>Signature. Qualitative and<br>quantitative hyperfibrinolysis<br>information from Sonoclot<br>Signature. | | Test Design | Pink plastic lidded cuvette<br>containing contact activator (glass<br>beads ) and magnetic stir bar | Colorless plastic lidded cuvette<br>containing contact activator (celite)<br>and magnetic stir bar | | Kit Contents | Cuvettes, probes and instructions<br>for use | Cuvettes, probes and instructions<br>for use | | Quality Control | Reference Plasma Quality Control<br>Kit, Sienco part #900-1318 | Reference Plasma Quality Control<br>Kit, Sienco part #900-1318 | 510(k) Summary - Page 2 of 3 : . .. ー…。 『 ! {2}------------------------------------------------ - (7) Performance Comparison of the gbACT+ Kit to the standard SonACT Kitt Expected Performance Comparison of the goACT The to the standard SonACT in the lables below. values for the gbACT+ Kit and the standard SonACT to estandard values for the gDACT+ Tric and the standard Somro-Print as pro-SonACT test are also included. #### gbACT+ Typical Results and Examples | gbACT+ Test (#800-0411, 800-0412)<br>Native Whole Blood - Normal Population, No Heparin | | |-----------------------------------------------------------------------------------------|----------------------------------| | Result | Normal Range | | ACT/Onset | 125 - 220 seconds | | Clot RATE | 10-45 Clot Signal Units / minute | | Time to Peak | <20 minutes | ### Normal A: Native Whole Blood: gbACT+ Image /page/2/Figure/4 description: The image shows three lines of text related to medical measurements. The first line reads "Onset/ACT: 167", indicating a value of 167 for Onset/ACT. The second line reads "ClotRATE: 15", indicating a ClotRATE value of 15. The third line reads "Time to Peak: 8", indicating a Time to Peak value of 8. Image /page/2/Figure/5 description: The image shows a graph of a clot signal over time. The y-axis represents the clot signal, and the x-axis represents time. The graph shows an initial increase in the clot signal, followed by a peak, and then a gradual decrease. The onset is labeled as 169, and the rate is 15. # Normal B: Native Whole Blood: gbACT+ Onset/ACT: 149 ClotRATE: 9 Time to Peak: 12 Image /page/2/Figure/20 description: The image shows a graph of a clot signal. The x-axis is labeled "SIEN.D. INC." and ranges from 0 to 20. The y-axis is labeled "Clot Signal" and ranges from 0 to 120. The graph shows two peaks, one at approximately x=5 and y=40, and another at approximately x=12 and y=80. The text "Onset=149" and "帆-1.3" are also visible on the graph. #### SonACT Typical Results and Examples for Comparison | Standard SonACT Test (#800-0432, #800-0431)<br>Native Whole Blood - Normal Population, No Heparin | | |---------------------------------------------------------------------------------------------------|----------------------------------| | Result | Normal Range | | ACT/Onset | 85-145 seconds | | Clot RATE | 15-45 Clot Signal Units / minute | | Time to Peak | <30 minutes | # Normal A: Native Whole Blood: SonACT Image /page/2/Figure/12 description: The image shows a graph of clot signal over time. The graph shows an initial increase in clot signal, followed by a peak and then a gradual decrease. The image also includes some text, which indicates that the onset/ACT is 89, the clot rate is 22, and the time to peak is 17. The y axis is labeled clot signal and the x axis is not labeled. ### Normal B: Native Whole Blood: SonACT Image /page/2/Figure/14 description: The image shows a graph of a clot signal over time. The graph shows the clot signal increasing to a peak, then decreasing. The image also includes the following values: Onset/ACT: 91, ClotRATE: 10, and Time to Peak: 20. Barbara DeBiase, Director rbara DeBiase, Director {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right. MAY 2 8 1939 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Barbara Debiase SIENCO, INC. 4892 Van Gordon Street Unit 203 80033 Wheatridge, CO - Re: K984141 Trade Name: gbACT + Kit Requlatory Class: II Product Code: JBP Dated: May 11, 1999 Received: May 12, 1999 Dear Ms. Debiase: 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 qeneral 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 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 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. {4}------------------------------------------------ #### 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 {5}------------------------------------------------ Page_ 1_of_1 510(k) Number (if known): \$944 / 41 Device Name: ### Indications For Use: The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The gbACT+ test is an activated whole blood clotting time test. It may also be used with citrated whole blood or plasma. The gbACT+ Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management at low to moderate heparin levels (0 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <img alt="Signature" src="signature.png"/> | |-----------------------------------------|--------------------------------------------| | (Division Sign-Off) | | | Division of Clinical Laboratory Devices | | | 510(k) Number | K984141 | | Prescription Use | <div style="text-align:center;">✓</div> | |----------------------|-----------------------------------------| | (Per 21 CFR 801.109) | | OR | Over-The-Counter Use | _________________ | |--------------------------|-------------------| | (Optional Format 1-2-96) | |