(82 days)
The Stratus® CS D-dimer CalPak is an in vitro diagnostic product used to calibrate the Stratus® D-dimer method on the Stratus® CS STAT fluorometric analyzer. This calibrator is intended for medical purposes to establish points of reference that are used in the determination of D-dimer concentration in human specimens.
The Stratus® CS D-dimer CalPak consists of a plastic cartridge (CalPak) containing human D-dimer in a liquid, buffered bovine protein matrix in each of three wells. The CalPak is designed for use only on the Stratus® CS analyzer.
This document is a 510(k) premarket notification for a calibrator device, not an AI/ML diagnostic or prognostic device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of submission.
The document focuses on demonstrating substantial equivalence to a predicate device, which is the primary regulatory pathway for calibrators. The key aspects are the comparison of intended use, design, and performance characteristics (though specific performance data like accuracy or precision of the calibration itself are not detailed in this summary).
Here's an attempt to address the applicable parts of your request based on the provided text:
Acceptance Criteria and Device Performance for Stratus® CS D-dimer CalPak
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from substantial equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Calibration of corresponding D-dimer method | Calibration of Stratus® D-dimer method on Stratus® CS STAT fluorometric analyzer. Substantially equivalent to predicate's intended use. |
| Design/Composition | Liquid, buffered bovine protein matrix, human D-dimer. | Liquid, stored frozen; buffered bovine protein matrix with human D-dimer, stabilizers, and sodium azide. Substantially equivalent in design to predicate. |
| Packaging | Suitable for specific analyzer | Sealed plastic cartridge for use only on the Stratus® CS analyzer. |
| Calibration Method | Functional calibration system | Calibration curve updated for each lot initially (in triplicate) and every 60 days thereafter using Master lot values. Recovered values automatically calculated from stored calibration coefficients. |
| Substantial Equivalence | Demonstrated equivalence to predicate device in intended use and design for regulatory approval. | The device is deemed substantially equivalent to the VIDAS® D-dimer Calibrator. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a calibrator, which primarily demonstrates substantial equivalence to a predicate device. It does not involve a "test set" in the context of evaluating a diagnostic algorithm's performance against patient data. The "test" mentioned relates to the calibration procedure itself (e.g., "After completion of each test, the recovered values are automatically calculated...").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2.
4. Adjudication method for the test set
- Not Applicable. See point 2.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used
- Not Applicable directly in a diagnostic performance sense. For a calibrator, the "truth" is established by the known concentration of the D-dimer within the calibrator material itself, which is then used to set the instrument's reference points for measuring unknown samples. The document doesn't detail the method of how the D-dimer concentration in the calibrator was precisely determined, but it would involve analytical chemistry and highly controlled reference materials.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
Study Proving Acceptance Criteria:
The "study" that proves the device meets its "acceptance criteria" is the 510(k) premarket notification process itself, specifically the comparison to the predicate device.
The document explicitly states:
"Both the Dade Behring Stratus® CS D-dimer CalPak and the VIDAS® D-dimer calibrator products are intended to calibrate their respective closed system methods utilizing similar designs consisting of human blood products in a buffered, bovine protein-based matrix."
"The Stratus® CS D-dimer CalPak is substantially equivalent in intended use and design to the VIDAS® D-dimer calibrator as noted above."
This statement, reviewed and accepted by the FDA (as indicated by the clearance letter), serves as the evidence that the device meets the regulatory acceptance criteria for market entry as a substantially equivalent device. The underlying details of the analytical performance of the calibrator (e.g., its accuracy, stability, commutability) would have been part of the full 510(k) submission, even if not fully detailed in this summary. However, the core "proof" presented here for regulatory acceptance relies on this substantial equivalence argument.
§ 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).