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Found 15 results
510(k) Data Aggregation
K Number
K102552Device Name
HEMOSIL LA POSITIVE CONTROL
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2011-04-05
(210 days)
Product Code
GGC, GGN, GIZ
Regulation Number
864.5425Why did this record match?
Product Code :
GGC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- HemosIL LA Positive Control .
For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
- . HemosIL LA Negative Control
For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
Device Description
- . HemosIL LA Positive Control
The LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer, which has been determined to be positive for LA in accordance with the Guidelines from ISTH1.
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
- HemosIL LA Negative Control
The LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a Pooled Normal Plasma with added buffer. The guidelines from ISTH', recommends a plateletpoor plasma as a negative control for Lupus Anticoagulant (LA).
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
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K Number
K100103Device Name
SPECIALTY ASSAYED CONTROL-2
Manufacturer
HELENA LABORATORIES
Date Cleared
2010-12-15
(336 days)
Product Code
GGC
Regulation Number
864.5425Why did this record match?
Product Code :
GGC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K062306Device Name
PLASMACON N, PLASMACON L-1, PLASMACON L-2
Manufacturer
R2 DIAGNOSTICS, INC.
Date Cleared
2007-03-16
(220 days)
Product Code
GGC, GIZ
Regulation Number
864.5425Why did this record match?
Product Code :
GGC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PlasmaCon N is a human lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
PlasmaCon L-1 is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.
Device Description
The PlasmaCon Control Plasma devices contain lyophilized citrated human plasma, for use in the verification of system performance for PT and aPTT assays.
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K Number
K061803Device Name
STA - CONTROL LA 1+2
Manufacturer
DIAGNOSTICA STAGO, INC.
Date Cleared
2006-07-28
(31 days)
Product Code
GGC, GGN
Regulation Number
864.5425Why did this record match?
Product Code :
GGC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of the tendsma for LA detection carried out with the following tests: STA® -Staclor® dRVV Screen (#00339 & #00333) STA® -Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)
Device Description
The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of LA testing using the following kits: STA® - Staclot® dRVV Screen (#00339 & 00333) STA® - Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)
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K Number
K032804Device Name
CRYOCHECK WEAK LUPUS POSITIVE CONTROL
Manufacturer
PRECISION BIOLOGIC
Date Cleared
2003-11-03
(55 days)
Product Code
GGC
Regulation Number
864.5425Why did this record match?
Product Code :
GGC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CryoCheck Weak Lupus Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.
Device Description
CryoCheck Weak Lupus Positive Control contains citrated human plasma collected from donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants. Source plasmas are processed in a manner that yields platelet-poor plasmas. Plasma is then buffered, aliquoted and rapidly frozen.
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K Number
K023312Device Name
CONTROL PLASMA P
Manufacturer
DADE BEHRING, INC.
Date Cleared
2002-11-01
(29 days)
Product Code
GGC
Regulation Number
864.5425Why did this record match?
Product Code :
GGC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Control Plasma P is assayed for use as an accuracy control of the following parameters in the pathological range: Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Fibrinogen (Clauss method); Coagulation factors II, V, VII, VIII, VWf, IX, X, XI, XII and XIII*; Inhibitors: Antithrombin III, Protein C, Protein S, a2-antiplasmin, C, inhibitor*; Total complement activity*, Plasminogen. (* Not available in the U.S.)
Device Description
Control Plasma P is a lyophilized control prepared from pooled human plasma, adjusted to defined factor concentrations, and then stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the accuracy and precision of coagulation and fibrinolysis tests in the pathological ranqe.
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K Number
K020878Device Name
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
Manufacturer
BIO-RAD
Date Cleared
2002-04-15
(28 days)
Product Code
GGC
Regulation Number
864.5425Why did this record match?
Product Code :
GGC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Device Description
Lyphochek® Hemostasis Control is prepared from human plasma with added purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.
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K Number
K020109Device Name
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2002-02-06
(26 days)
Product Code
GGC
Regulation Number
864.5425Why did this record match?
Product Code :
GGC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sigma Diagnostics ACCUCLOT™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT). Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
Device Description
Sigma Diagnostics ACCUTROL™ LA Control is a lyophilized human plasma based product. After reconstitution with water, ACCUTROL™ LA Control is stable for 48 hours when stored at 2-8°C and 4 weeks when stored at -20°C.
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K Number
K012422Device Name
K-ASSAY D-DIMER CONTROLS
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
2001-08-21
(22 days)
Product Code
GGC
Regulation Number
864.5425Why did this record match?
Product Code :
GGC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays.
Device Description
Not Found
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K Number
K003329Device Name
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2001-03-01
(128 days)
Product Code
GGC
Regulation Number
864.5425Why did this record match?
Product Code :
GGC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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