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Quantex D-DIMER is a latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on automated clinical chemistry analyzers.

Quantex D-DIMER is a latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on automated clinical chemistry analyzers. The quantex D-DIMER Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. When a plasma containing D-Dimer is mixed with the Latex Reagent and the Reaction Buffer included in the quantex D-DIMER kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of the transmitted light caused by the aggregates (turbidimetric immunoassay).

Here's a breakdown of the acceptance criteria and study details for the quantex D-DIMER device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K032419 for quantex D-DIMER) does not explicitly state pre-defined acceptance criteria values in the way one might see for diagnostic accuracy metrics (e.g., "sensitivity must be >90%"). Instead, the performance is demonstrated through a method comparison with a predicate device and precision studies, indicating that the new device's performance should be substantially equivalent to the predicate.

Given the information provided, we can infer the performance metrics reported:

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