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510(k) Data Aggregation
K Number
K062593Device Name
CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET
Manufacturer
Date Cleared
2006-11-22
(82 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
COMPASS BIOSCIENCE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Compass Bioscience Cardiac Markers Controls are to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the antigens and enzymes contained in the control. It is intended to validate the measurement of these analytes in patient samples.
Three levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.
The Compass Bioscience Cardiac Marker Calibration Control Set is used to verify the calibration of various test methods over the measurable range of the test.
Device Description
Compass Bioscience Cardiac Markers Controls are supplied in three levels, 2 x 1 mL each level per box and as a four Level Calibration Verification set, 2 x 1 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a human EDTA plasma matrix fortified to target levels with human source material and reagent grade chemicals added at different concentrations to achieve the levels. Sodium Azide <0.1% has been added as preservative to inhibit microbial growth.
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K Number
K060570Device Name
HEMOGLOBIN ALC CONTROL
Manufacturer
Date Cleared
2006-04-13
(38 days)
Product Code
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
COMPASS BIOSCIENCE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Compass Bioscience Hemoglobin A1c Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure Hemoglobin A1c levels. It is intended to validate the measurement of Hemoglobin A1c in patient samples.
Two levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.
Device Description
The Compass Bioscience Hemoglobin A1c Control is supplied as frozen liquid in two levels and consists of a human whole blood matrix adjusted to target concentrations of glycated hemoglobin (HbA1c) and containing preservatives and stabilizers. Assayed values are determined from interlaboratory data.
Hemoglobin A1c Assayed Controls are supplied in two levels, 3 x 1 mL each level per box . The controls are supplied as a ready-to-use frozen liguid, requiring no reconstitution or dilution. They are prepared in a human whole blood matrix adjusted to target concentrations of HbA1c. Stabilizers and preservatives have been added to inhibit microbial growth.
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