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Found 16 results
510(k) Data Aggregation
K Number
K242952Device Name
INNOVANCE Antithrombin
Manufacturer
Siemens Healthcare Diagnostic Products GmbH
Date Cleared
2025-03-28
(184 days)
Product Code
JBQ
Regulation Number
864.7060Why did this record match?
Product Code :
JBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INNOVANCE Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency.
INNOVANCE Antithrombin is indicated as an aid in monitoring antithrombin activity to support QFITLIA (fitusiran) dosing in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.
Device Description
The INNOVANCE Antithrombin assay is suitable for the determination of physiologically active antithrombin on automatic analyzers and enables the diagnosis of inherited or acquired antithrombin deficiencies. The INNOVANCE Antithrombin assay utilizes a chromogenic measuring principle. An excess of human factor Xa is added to citrated plasma. In the presence of heparin, a portion of the enzyme is complexed and inactivated by the antithrombin present in the sample. Excess, uninhibited factor Xa then cleaves a specific chromogenic substrate, causing the release of a dye. The substrate cleavage is determined by the increase in the absorbance value at 405 nm. The release of dye is inversely proportional to the inhibiting activity of antithrombin in the plasma sample, i.e., the smaller the concentration of functionally active antithrombin, the higher the absorbance signal per time unit.
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K Number
K081769Device Name
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS
Date Cleared
2009-05-28
(339 days)
Product Code
JBQ
Regulation Number
864.7060Why did this record match?
Product Code :
JBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INNOVANCE™ Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency.
Device Description
The INNOVANCE™ Antithrombin assay utilizes a chromogenic measuring principle. An excess of factor Xa is added to citrated plasma. In the presence of heparin, a portion of the enzyme is complexed and inactivated by the antithrombin present in the sample. Excess, uninhibited factor Xa then cleaves a specific chromogenic substrate, causing the release of a dye. The rate of the substrate cleavage is determined by the increase in the absorbance value at 405 nm.
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K Number
K070301Device Name
HEMOSIL ANTITHROMBIN
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2007-02-23
(23 days)
Product Code
JBQ
Regulation Number
864.7060Why did this record match?
Product Code :
JBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemosIL Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
Device Description
HemosIL Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
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K Number
K062431Device Name
HEMOSIL LIQUID ANTITHROMBIN
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2006-09-01
(11 days)
Product Code
JBQ
Regulation Number
864.7060Why did this record match?
Product Code :
JBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.
Device Description
HemosIL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.
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K Number
K043007Device Name
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
Manufacturer
HYPHEN BIOMED
Date Cleared
2005-11-07
(371 days)
Product Code
JBQ, 81J
Regulation Number
864.7060Why did this record match?
Product Code :
JBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
Device Description
Biophen Antithrombin 2.5 and 5 kit, an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the Antithrombin concentration in human plasma, in instances of recurrent thrombosis resulting from a congenital or acquired deficiency of Antithrombin.
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K Number
K033775Device Name
HEMOSIL LIQUID ANTITHROMBIN XL
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2004-01-02
(30 days)
Product Code
JBQ
Regulation Number
864.7060Why did this record match?
Product Code :
JBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. For in vitro diagnostic use.
Device Description
HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.
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K Number
K023991Device Name
CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
Manufacturer
PRECISION BIOLOGIC
Date Cleared
2003-04-28
(146 days)
Product Code
JBQ
Regulation Number
864.7060Why did this record match?
Product Code :
JBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ChromoCheck™ Antithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.
Device Description
ChromoCheck™ Antithrombin is a chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer
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K Number
K022550Device Name
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2002-08-27
(25 days)
Product Code
JBQ, JBO
Regulation Number
864.7060Why did this record match?
Product Code :
JBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).
Device Description
Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).
Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.
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K Number
K022195Device Name
COAMATIC AT-400
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2002-08-07
(33 days)
Product Code
JBQ
Regulation Number
864.7060Why did this record match?
Product Code :
JBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.
Device Description
Coamatic® AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.
Antithrombin is the most important natural inhibitor of the coagulation cascade. Bv inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 10-125% of normal plasma.
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K Number
K994238Device Name
IL TEST LIQUID ANTITHROMBIN
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2000-06-23
(190 days)
Product Code
JBQ
Regulation Number
864.7060Why did this record match?
Product Code :
JBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency.
Device Description
IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency.
This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.
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