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Found 26 results
510(k) Data Aggregation
K Number
K974343Device Name
DADE INNOVIN
Manufacturer
DADE INTL., INC.
Date Cleared
1998-07-22
(245 days)
Product Code
GJS
Regulation Number
864.7750Why did this record match?
Applicant Name (Manufacturer) :
DADE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in prothrombin time determinations and prothrombin time-based assays.
Device Description
Dade® Innovin® is a lyophilized preparation of purified recombinant human tissue factor produced in E. coli combined with synthetic phospholipids, calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.
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K Number
K970505Device Name
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
Manufacturer
DADE INTL., INC.
Date Cleared
1997-11-17
(280 days)
Product Code
JOZ
Regulation Number
864.5700Why did this record match?
Applicant Name (Manufacturer) :
DADE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To aid in the detection of platelet dysfunction in citrated human whole blood for use in patients with a suspected disorder of primary hemostasis.
Device Description
The Dade® PFA-100™ system is an instrument and test reagents in which the process of platelet adhesion and aggregation following a vascular injury is simulated in vitro. Platelet dysfunction detected by the PFA-100 system may be acquired, inherited or induced by platelet inhibiting agents. The PFA-100 system allows for rapid evaluation of platelet function on small samples of anticoagulated whole blood. The single use test cartridge reagents consists of a number of integrated parts including a capillary, a sample reservoir and a biologically active membrane with a central aperture. By application of a constant vacuum, anticoagulated whole blood is aspirated from the sample reservoir through the capillary and the aperture under standardized rheological conditions that expose platelets to high shear stress. The membrane is coated with collagen and one additional agonist. At the beginning of a test, Trigger Solution is dispensed to wet the membrane. Similar to the in vivo mechanism, platelets adhere and aggregate at the aperture thereby gradually diminishing and finally arresting the blood flow. The instrument determines the time from the start of the test until the platelet plug occludes the aperture, and reports that time interval as the Closure Time. Platelet plug formation in the PFA-100 system is dependent on adequate platelet activity and adequate von Willebrand factor status. Therefore, the Closure Time is an indicator of the platelet function in the analyzed whole blood sample.
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K Number
K973974Device Name
DADE TRU-LIQUID CARDIAC CONTROL
Manufacturer
DADE INTL., INC.
Date Cleared
1997-11-06
(17 days)
Product Code
JJT
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
DADE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac marker procedures.
Device Description
Dade® TRU-Liquid™ Cardiac Control Levels 1,2 and 3. Liquid Tri-Level Cardiac Control. Quality Control Material (Assayed and Unassayed).
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K Number
K973668Device Name
CARDIAC TROPONIN-I (TROP) CALIBRATOR
Manufacturer
DADE INTL., INC.
Date Cleared
1997-10-20
(25 days)
Product Code
JIT
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
DADE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardiac Troponin-I Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
Device Description
The Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 8, 25, and 55 ng/mL containing cardiac troponin-l in a buffered bovine protein matrix. The kit consists of five vials; two at each level.
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K Number
K972524Device Name
DRIED GRAM-POSITIVE MIC/COMBO PANELS
Manufacturer
DADE INTL., INC.
Date Cleared
1997-09-08
(63 days)
Product Code
JWY
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
DADE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To determine gram-positive bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Sparfloxacin Gram-Positive Bacteria Staphylococcus aureus
Device Description
Microdilution Minimum Inhibitory Concentration (MIC) Panels
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K Number
K972782Device Name
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
Manufacturer
DADE INTL., INC.
Date Cleared
1997-08-15
(21 days)
Product Code
JHX
Regulation Number
862.1215Why did this record match?
Applicant Name (Manufacturer) :
DADE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infaction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Device Description
The Dade Stratus® CK-MB Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the MB isoenzyme of creatine kinase. The assay can be processed on the Stratus® analyzer, the Stratus® II analyzer or the Stratus® IIntellect analyzer.
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K Number
K972287Device Name
DADE TRU-LIQUID BILIRUBIN CONTROL
Manufacturer
DADE INTL., INC.
Date Cleared
1997-07-07
(18 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
DADE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dade TRU-Liquid Bilirubin Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and in the monitoring of accuracy and precision.in the clinical laboratory assay of ... .. bilirubin.
Device Description
Dade® TRU-Liquid™ Bilirubin Control Levels 1,2 and 3. Liquid Tri-Level Bilirubin Control. Quality Control Material (Assayed and Unassayed).
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K Number
K964660Device Name
PARAMAX CHOLESTEROL REAGENT
Manufacturer
DADE INTL., INC.
Date Cleared
1997-06-04
(196 days)
Product Code
CHH
Regulation Number
862.1175Why did this record match?
Applicant Name (Manufacturer) :
DADE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For quantitative determination of cholesterol or HDL cholesterol in plasma or serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders'.
Device Description
The Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent are based on colormetic methodology.
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K Number
K970676Device Name
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
Manufacturer
DADE INTL., INC.
Date Cleared
1997-05-02
(67 days)
Product Code
JWY
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
DADE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To determine antimicrobial agent susceptibility
Device Description
Microdilution Minimum Inhibitory Concentration (MIC) Panels, specifically MicroScan™ Dried Gram-Negative MIC/Combo Panels
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K Number
K964715Device Name
PARAMAX SALICYLATE REAGENT
Manufacturer
DADE INTL., INC.
Date Cleared
1997-04-25
(151 days)
Product Code
DKJ
Regulation Number
862.3830Why did this record match?
Applicant Name (Manufacturer) :
DADE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paramax® Salicylate Reagent is intended for use as quantitative determination of salicylate in plasma and serum.
Device Description
The Paramax® Salicylate Reagent is based on colormetric methodology.
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