(549 days)
The D-Dimer Assay is for the quantitative determination of fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only.
The Diazyme D-Dimer Calibrator Set is intended for use of the calibration of the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.
The Diazyme D-Dimer Control Set is intended for use as quantitative quality controls for the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.
Diazyme's D-Dimer Assay is based on a latex enhanced immunoturbidimetric assay. D-Dimer proteins in the sample bind to the specific anti-D-Dimer antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of D-Dimer in the sample. The instrument calculates the D-Dimer concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve.
Here's a breakdown of the acceptance criteria and study information for the Diazyme D-Dimer Assay Kit, Diazyme D-Dimer Assay Calibrator Set, and Diazyme D-Dimer Assay Control Set, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (Diazyme D-Dimer Assay) |
|---|---|---|
| Linear Range | 0.15 - 9 µg/mL FEU D-Dimer (Predicate: Roche Tina-Quant D-Dimer K062203) | 0.15 - 8 µg/mL FEU D-Dimer |
| Precision (CV%) | 0.8 - 8.3% (Predicate: Roche Tina-Quant D-Dimer K062203) | Internal Study: |
- Plasma Samples Within Run: 1.4% - 5.0%
- Plasma Samples Total: 2.7% - 6.2%
- Control Samples Within Run: 1.4% - 2.9%
- Control Samples Total: 2.8% - 4.4%
External Study: - Total CV%: 3.5% - 11.5% |
| Correlation Coefficient (Method Comparison) | 0.775 (Predicate: vs. Asserachrom D-Dimer K862156) | 0.939 (vs. Roche Tina-Quant D-Dimer K062203) |
| Slope (Method Comparison) | 1.03 (Predicate: vs. Asserachrom D-Dimer K862156) | 0.979 (vs. Roche Tina-Quant D-Dimer K062203) |
| Intercept (Method Comparison) | -0.11 (Predicate: vs. Asserachrom D-Dimer K862156) | -0.106 (vs. Roche Tina-Quant D-Dimer K062203) |
| Bias around medical decision point | Not explicitly stated for predicate in summary, but typical for method comparison studies. | -0.12 µg/mL FEU |
| Limit of Blank (LOB) | Not explicitly stated for predicate. | 0.06 µg/mL FEU |
| Limit of Detection (LOD) | Not explicitly stated for predicate. | 0.09 µg/mL FEU |
| Limit of Quantitation (LOQ) | Not explicitly stated for predicate. | 0.15 µg/mL FEU (target CV
§ 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).