(76 days)
For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies.
Fibrinogen is a plasma protein which is converted from a soluble protein to an insoluble polymer by the action of thrombin resulting in the formation of a fibrin clot. The thrombin clotting time of dilute plasma is inversely proportional to the fibrinogen concentration of the plasma. Using this principle, Clauss developed a simple quantitative assay for fibrinogen by measuring the clotting time of dilute plasma when excess thrombin is added. The clotting time obtained is then compared with that of a standardized fibrinogen preparation.
Here's a breakdown of the acceptance criteria and study details for the Dade® Thrombin Reagent, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria for the Dade® Thrombin Reagent is demonstrated through a method comparison study against the legally marketed predicate device, the Dade® Fibrinogen Determination Reagents kit. The acceptance criteria are implicit in the "Correlation Coefficient" values, indicating a strong correlation between the new device and the predicate.
| Acceptance Criteria (Stated/Inferred) | Reported Device Performance (Dade® Thrombin Reagent vs. Dade® Fibrinogen Determination Reagents) |
|---|---|
| High Correlation (e.g., >0.90) with Predicate Device | Slope: 1.03, Intercept: -0.063, Correlation Coefficient: 0.995 (for SHP Lot # 502587) |
| Slope: 0.946, Intercept: -0.027, Correlation Coefficient: 0.993 (for SHP Lot # 502589) |
Study Details
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 80 samples were used for each of the two lots tested (SHP Lot # 502587 and SHP Lot # 502589), for a total of 160 samples in the method comparison study.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This is an in vitro diagnostic device for quantitative determination, not an imaging or qualitative diagnostic device requiring expert interpretation of results for ground truth establishment in the traditional sense. The "ground truth" for comparison is the performance of the legally marketed predicate device.
-
Adjudication Method for the Test Set:
- Not applicable, for the same reasons as point 2. The comparison is quantitative against a predicate device.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this type of study was not done. MRMC studies are typically used for imaging devices or diagnostics that involve human interpretation, which is not the primary function of this in vitro diagnostic reagent.
-
If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:
- Yes, in a sense. The performance presented is for the reagent itself, functioning on an instrument. There is no "human-in-the-loop" component in the direct measurement process of a fibrinogen level using a coagulation assay. The device determines the fibrinogen level directly.
-
The Type of Ground Truth Used:
- Comparative Ground Truth: The "ground truth" for this device's performance evaluation is established by comparison to a legally marketed predicate device. The predicate device itself (Dade® Fibrinogen Determination Reagents kit) serves as the reference standard. The study aims to show that the new device produces results that are highly correlated and comparable to the established method.
-
The Sample Size for the Training Set:
- The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. For a reagent test, development typically involves analytical validation and optimization rather than a separate training set for a "machine learning" algorithm.
-
How the Ground Truth for the Training Set was Established:
- Not applicable, as a discrete "training set" with established ground truth as understood in machine learning is not described or required for this type of in vitro diagnostic reagent. The development of such reagents generally relies on established chemical and biological principles, optimization through analytical testing, and ultimately validation against reference methods or clinical samples.
§ 864.7340 Fibrinogen determination system.
(a)
Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).(b)
Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.