(115 days)
System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers.
Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.
In this Olympus procedure, the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the immunological reaction between the D-Dimer of the patient serum and the anti-human D-Dimer antibodies coated on the latex particles
The Olympus D-Dimer Test System, consisting of the Olympus D-Dimer Reagent, Calibrator, and Control, is intended for the quantitative determination of D-Dimer in human plasma on Olympus analyzers. It is designed to aid in detecting the presence and degree of intravascular coagulation and fibrinolysis and in monitoring therapy for disseminated intravascular coagulation.
Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary compares the Olympus D-Dimer Test System with the predicate device, Roche Tina-Quant® D-Dimer Test System. The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate, with specific performance characteristics indicating acceptable levels.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Olympus D-Dimer Test System Performance |
|---|---|---|
| Precision (Total CV%) | Sample 1: 6.5% | AU400/400e: 9.44% |
| AU600/640/640e: 9.14% | ||
| AU2700/5400: 8.17% | ||
| Sample 2: 8.3% | AU400/400e: 7.99% | |
| AU600/640/640e: 7.95% | ||
| AU2700/5400: 4.44% | ||
| Sample 3: 3.2% | AU400/400e: 2.48% | |
| AU600/640/640e: 3.02% | ||
| AU2700/5400: 2.52% | ||
| Assay Range | 0.15 - 9.0 µg FEU/mL | 0.15 - 8.00 µg FEU/mL |
| Analytical Sensitivity | 0.04 µg FEU/mL | 0.08 µg FEU/mL |
| Method Comparison | Intercept: 0.06 | |
| Slope: 0.87 | ||
| R2: 0.755 | ||
| Range: 0.08-4.55 µg FEU/mL | Intercept: 0.079 | |
| Slope: 1.010 | ||
| R2: 0.996 | ||
| Range: 0.28-7.53 µg FEU/mL | ||
| Interfering Substances | Within ±10% variation: |
- Bilirubin up to 20 mg/dL
- Hemolysis up to 500 mg/dL Hemoglobin
- Rheumatoid Factor
§ 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).