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510(k) Data Aggregation
K Number
K223635Device Name
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
Manufacturer
Sienco, Inc.
Date Cleared
2023-01-04
(30 days)
Product Code
JBP
Regulation Number
864.7140Why did this record match?
Applicant Name (Manufacturer) :
Sienco, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.
The Sonoclot Analyzer System generates a qualitative graph, known a the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
Device Description
The Sonoclot Coaqulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.
The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
Sonoclot Viewer is a data collection, storage, and retrieval program for use with Sonoclot Analyzers. Sonoclot Viewer collects serial data from one or more Sonoclot Analyzers. This data is compressed, processed for certain performance results, displayed, and stored as data files.
Sonoclot Viewer enables users to assign patient, operator, and reagent information to a test, manage patient test results and analyzer/reagent quality control data, communicate with the hospital information system, and create reports to meet billing or regulatory compliance requirements.
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K Number
K032952Device Name
AIACT KIT
Manufacturer
SIENCO, INC.
Date Cleared
2003-12-12
(81 days)
Product Code
JBP
Regulation Number
864.7140Why did this record match?
Applicant Name (Manufacturer) :
SIENCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.
The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT ≥ 400 seconds on Sonoclot Analyzer) as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment.
Device Description
The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.
The aiACT Kit is a yellow plastic lidded cuvette containing contact activator and magnetic stir bar.
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K Number
K002528Device Name
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION
Manufacturer
SIENCO, INC.
Date Cleared
2000-08-31
(15 days)
Product Code
JBP
Regulation Number
864.7140Why did this record match?
Applicant Name (Manufacturer) :
SIENCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K984141Device Name
GBACT + KIT
Manufacturer
SIENCO, INC.
Date Cleared
1999-05-28
(191 days)
Product Code
JBP
Regulation Number
864.7140Why did this record match?
Applicant Name (Manufacturer) :
SIENCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 (1 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.
Device Description
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.
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