(22 days)
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in D-dimer assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
Sigma Diagnostics AUTO D-Dimer Control, Level 3 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 3 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.
The provided text is a 510(k) summary for the Sigma Diagnostics AUTO D-Dimer Control, Level 3. This document describes a control product used in laboratory assays, not a diagnostic device that directly measures patient parameters or relies on an algorithm. Therefore, many of the requested categories in the prompt are not applicable to this type of product.
Here's an attempt to answer the questions based on the available information, noting where information is not relevant or not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Sigma Diagnostics AUTO D-Dimer Control, Level 2, Cat. No. A5217, K003329) | Demonstrated substantial equivalence to the predicate device. The Level 3 control is suitable for use as an elevated (abnormal) control. |
| Stability when reconstituted and stored at 2-8°C | Stable for 3 days |
| Stability when reconstituted and stored at 18-26°C | Stable for 24 hours |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The document focuses on demonstrating substantial equivalence to a predicate device, which for a control product often involves analytical performance testing rather than clinical study data with human patient samples. The control itself is human plasma-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. For a control product, "ground truth" typically refers to the expected value or range of the control, which is established through analytical testing and characterization against reference methods or the assay it's designed to control. It does not involve expert consensus in the same way a diagnostic imaging device might.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically associated with expert review of complex diagnostic cases, not with the analytical performance assessment of a laboratory control.
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 a laboratory control product, not an AI-powered diagnostic device, and thus MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a control product, the "ground truth" refers to its characterized properties and values, often established through:
- Analytical testing using established reference methods.
- Comparison to existing, legally marketed controls (as implied by substantial equivalence to Level 2 control).
- Quantitative measurements made with the assay the control is designed to monitor.
The document indicates it is a human plasma-based product, and its intended use is as an "abnormal control" (Level 3) with patient citrated plasma in D-dimer assays. This implies its D-dimer level is elevated and characterized accordingly.
8. The sample size for the training set
Not applicable. This is a control product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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).