Search Results
Found 25 results
510(k) Data Aggregation
K Number
K090940Device Name
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
Manufacturer
ASTORIA-PACIFIC,INC.
Date Cleared
2009-12-14
(255 days)
Product Code
JJT
Regulation Number
862.1660Why did this record match?
Product Code :
JJT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SPOTCHECK Blood Spot Controls are used for monitoring assay performance during in vitro diagnostic newborn screening for deficient Galactose-1-phosphate UridyItransferase (GALT) and/or Biotinidase enzyme activity. Enzyme response quantitation is provided in the product insert.
Device Description
SPOTCHECK Blood Spot Controls. Part No. 80-0900P4K, Blood Spot Controls, Deficient; 4 cards. Part No. 80-0901P4K, Blood Spot Controls, Normal; 4 cards. The controls are prepared with mixtures of human serum and human red blood cells. adjusted to approximately 55% hematocrit. Enzyme activity in the Deficient Control is decreased by heating. Enzyme activity in the Normal Control is supported by the addition of dithioerythritol (DTE). The mixtures are spotted on Whatman 903A filter paper and allowed to air dry at room temperature. The suppliers of serum and red blood cells certify that the materials have been tested using FDA-approved assays and shown to be negative for infectious disease agents. The SPOTCHECK Blood Spot Controls provide an ongoing indication of the assay performance. The Deficient Control responds below the assay cutoff, and the Normal Control responds above the assay cutoff within normal limits.
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K Number
K062751Device Name
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2006-10-03
(19 days)
Product Code
JJT
Regulation Number
862.1660Why did this record match?
Product Code :
JJT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
Device Description
Not Found
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K Number
K030768Device Name
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
Manufacturer
CLINIQA CORPORATION
Date Cleared
2003-03-21
(10 days)
Product Code
JJT
Regulation Number
862.1660Why did this record match?
Product Code :
JJT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CLINIQA Liquid QC™ Cardiac Marker Control Levels 1, 2 & 3 Tri-LEVEL is intended for use as an assayed quality control material for analysis.
Device Description
Not Found
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K Number
K030102Device Name
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
Manufacturer
BAYER HEALTHCARE, LLC
Date Cleared
2003-01-24
(14 days)
Product Code
JJT, LIQ
Regulation Number
862.1660Why did this record match?
Product Code :
JJT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bayer Liquid Cardiac Markers 1, 2, 3 are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemical mass measurement test procedures for the ADVIA Centaur® andACS:180® Systems.
Device Description
The Bayer Liquid Cardiac Markers 1, 2, 3 are three separate levels of quality control material prepared from human serum with recombinant human CK-MB, human proteins, Digitoxin, Myoglobin, Troponin-I and Homocysteine.
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K Number
K021498Device Name
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
Manufacturer
BIO-RAD
Date Cleared
2002-05-24
(15 days)
Product Code
JJT, CFR
Regulation Number
862.1660Why did this record match?
Product Code :
JJT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Liquichek™ Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.
Device Description
Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.
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K Number
K012656Device Name
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
Manufacturer
BIO-RAD
Date Cleared
2001-09-06
(24 days)
Product Code
JJT, JJY
Regulation Number
862.1660Why did this record match?
Product Code :
JJT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An assayed quality control serum to monitor the precision of laboratory teating procedures for analytes listed in the package insert.
Device Description
Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.
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K Number
K993723Device Name
CARDIASURE CARDIAC MARKERS CONTROL
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
1999-11-23
(20 days)
Product Code
JJT
Regulation Number
862.1660Why did this record match?
Product Code :
JJT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantimetrix Cardiasure Assayed Controls are intended for use as quality control materials to assess the accuracy and precision of assay procedures for the analytes included in the control.
The Quantimetrix Cardiasure Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the specific serum analytes contained in the control material in order to validate the measurement of these analytes in patient samples.
Device Description
Cardiasure Assayed Controls are supplied in three levels, 3 x 3 mL each level per box and as a Tri-Level pack: 3 vials at 3 mL of each level; the controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a human serum matrix fortified to target levels with human source material and reagent grade chemicals added at different concentrations to achieve the three levels. Sodium Azide has been added as preservative to inhibit microbial growth.
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K Number
K993715Device Name
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
Manufacturer
SERACARE TECHNOLOGY
Date Cleared
1999-11-16
(13 days)
Product Code
JJT
Regulation Number
862.1660Why did this record match?
Product Code :
JJT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities.
Device Description
liquid human serum based assayed quality control material
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K Number
K992430Device Name
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
1999-08-30
(40 days)
Product Code
JJT
Regulation Number
862.1660Why did this record match?
Product Code :
JJT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring various immunoassay and general chemistry assays.
Include Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Device Description
Not Found
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K Number
K984437Device Name
QUANTEX ASO-CRP-RP CONTROL II
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
1999-02-02
(50 days)
Product Code
JJT
Regulation Number
862.1660Why did this record match?
Product Code :
JJT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents.
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.
Device Description
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents. When the combined control, which ADO prob, qualiten Ord problem of antistreptolysin-O, C-reactive protein and rheumatoid factor, commits a known asserver raias our suantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.
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