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510(k) Data Aggregation
(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: 0.06Slope: 0.87R2: 0.755Range: 0.08-4.55 µg FEU/mL | Intercept: 0.079Slope: 1.010R2: 0.996Range: 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 < 100 IU/mL- Heparin < 1.5 IU/mL- Lipemia up to 1500 mg/dL Triglyceride | Interference less than 10%:- Bilirubin: up to 40 mg/dL- Hemolysis: up to 500 mg/dL Hemolysate- Rheumatoid Factor: up to 100 IU/mL- Heparin: up to 1.5 IU/mL- Lipemia: up to 1000 mg/dL Intralipid (AU400/400e & 600/640/640e)- Lipemia: up to 700 mg/dL Intralipid (AU2700/5400) |
| Reagent On Board Stability | 28 Days | 30 days |
| Calibrator Open Vial Stability | 1 day @ 15 -25°C | 1 day @ 15 - 25°C28 days @ 2 - 8°C30 days @ -20°C |
| Control Open Vial Stability | 1 day @ 15 - 25°C14 days @ 2 - 8°C | 1 day @ 15 - 25°C28 days @ 2 - 8°C30 days @ -20°C |
| Calibration Stability | Not Specified | 30 days |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the sample size for the test set used in performance evaluations (e.g., precision, method comparison, interfering substances). It refers generically to "samples" for precision and provides a "Range" for method comparison without indicating the number of individual patient samples.
The data provenance (country of origin, retrospective/prospective) is not specified.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement, and its performance is assessed against established analytical methods and reference standards, not against expert human interpretation of images or other diagnostic findings.
4. Adjudication Method for Test Set
Not applicable. Clinical test performance is determined by a quantitative measurement against a comparative method.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not a medical imaging or diagnostic aid that involves human reader interpretation.
6. Standalone (Algorithm Only) Performance
Yes, the performance characteristics (Precision, Assay Range, Analytical Sensitivity, Method Comparison, Interfering Substances, Stability) represent the standalone performance of the Olympus D-Dimer Test System, as measured on Olympus analyzers, without human intervention in the result generation beyond operating the instrument.
7. Type of Ground Truth Used
The ground truth for evaluating the Olympus D-Dimer Test System implicitly relies on:
- A commercially available assay (predicate device, Roche Tina-Quant® D-Dimer) for method comparison. This assay itself would have been validated against a traceable standard.
- In-house Master Calibrator: The Olympus D-Dimer Test System is traceable to an in-house Master Calibrator.
- Defined concentrations/levels: For precision studies, specific "samples" (likely control materials or spiked plasma) are used with known D-Dimer concentrations. For interfering substances, known concentrations of bilirubin, hemoglobin, rheumatoid factor, heparin, and lipids are added to samples.
8. Sample Size for the Training Set
Not applicable. This is an analytical immunoassay, not a machine learning model that requires a "training set" in the conventional sense of AI/ML algorithms. The development and optimization of the reagent and assay would involve various experimental and testing phases, but these are not referred to as training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The calibration of the device is performed using a 6-point calibration curve, which is described as being traceable to an in-house Master Calibrator and aligned with another commercially available test system. This establishes the analytical accuracy of the measurements.
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