(80 days)
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:
| Performance Metric | Acceptance Criteria (Implied/Compared to Predicate) | Reported Device Performance (quantex D-DIMER) |
|---|---|---|
| Method Comparison (Correlation) | Substantially equivalent to predicate device performance (ideally high correlation). | Correlation (r) = 0.987 (compared to IL Test D-Dimer on ACL Futura) |
| Within-run Precision (CV) | Acceptable precision for a diagnostic assay (typically |
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).