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510(k) Data Aggregation
K Number
K112161Device Name
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
Manufacturer
RADIOMETER MEDICAL APS
Date Cleared
2012-01-20
(177 days)
Product Code
KHO, DDR, JIT, JJY
Regulation Number
862.2560Why did this record match?
Product Code :
KHO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.
AQT90 FLEX Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction.
AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer.
AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.
Device Description
The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.
This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.
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K Number
K973547Device Name
TRIAGE STATMETER
Manufacturer
BIOSITE INCORPORATED
Date Cleared
1998-01-13
(117 days)
Product Code
KHO, DDR, JHX, MMI
Regulation Number
862.2560Why did this record match?
Product Code :
KHO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fluometer for the measurement of fluorescence in various assay systems. General fluorometer.
Device Description
Not Found
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K Number
K971103Device Name
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
Manufacturer
TOSOH MEDICS, INC.
Date Cleared
1997-06-27
(93 days)
Product Code
KHO
Regulation Number
862.2560Why did this record match?
Product Code :
KHO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use. The NexlA is used in conjunction with the AIA-PACK reagent series to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders.
Device Description
The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use.
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K Number
K962919Device Name
VITROS IMMUNODIAGNOSTIC SYSTEM
Manufacturer
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
Date Cleared
1996-10-18
(84 days)
Product Code
KHO
Regulation Number
862.2560Why did this record match?
Product Code :
KHO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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