(41 days)
The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of crosslinked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens.
The provided document describes the Triage® D-Dimer Test, a fluorescence immunoassay for quantitative determination of D-dimer in blood and plasma. The K042890 submission establishes its substantial equivalence to a predicate device, the Triage® Profiler S.O.B. Panel (K040437).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance thresholds for sensitivity, specificity, accuracy, etc. Instead, it describes a method comparison study to demonstrate "substantial equivalence" to a predicate device, which implies that its performance should be comparable to the established predicate.
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Method Comparison (Correlation to Predicate) | Performance characteristics equivalent to predicate methods | Slope of 0.999, Intercept of -85.89, Correlation Coefficient of 0.92 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 180 specimens.
- Data Provenance: Not specified in the provided document. It does not mention the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in-vitro diagnostic test. The "ground truth" for the method comparison was based on the results from the predicate device, not on expert consensus or adjudication. The document does not mention any human readers or experts used to establish a ground truth for the device's performance in this context.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth was based on a predicate device's results, not on interpretation by experts requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. The study performed was a method comparison study between the new device and a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the study described is a standalone performance assessment of the Triage D-Dimer Test. It directly compares the quantitative results of the Triage D-Dimer Test to a predicate method, without involving human interpretation or a human-in-the-loop component for the device being evaluated.
7. The Type of Ground Truth Used
The ground truth for the method comparison study was established by the results obtained from the predicate device. The underlying "ground truth" for D-dimer measurements in general would be the actual concentration of D-dimer in the specimens, as measured by a validated method.
8. The Sample Size for the Training Set
The document does not provide information about a training set. The study described is an analytical performance study (method comparison) using 180 specimens. It is possible that the device underwent internal development and validation with other data, but this is not detailed in the 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set details are provided in the document.
§ 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).