(14 days)
The STA® vWF Control [N]+[P] kit provides two citrated human plasmas intended for use as a normal and an abnormal controls for von Willebrand Factor (vWF) antigen assays by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).
Each STA®-VWF Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF at the normal level (STA®-vWF Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF at the abnormal level (STA vWF Control [P]). Both the normal and abnormal plasmas in the freeze-dried state are stable for 24 months after the date of manufacture, when stored at 2°-8°C; after reconstitution with water, both plasmas are stable for 8 hours on board the STA® analyzer.
This document, K962674, is a 510(k) Premarket Notification for a control kit used in conjunction with a diagnostic device, specifically the STA®-vWF Control [N]+[P] kit. It is not describing a diagnostic device that produces a "result" in the traditional sense that would require performance metrics like sensitivity, specificity, or and AUC, or involve human readers or AI.
Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication, MRMC, standalone performance, training set details) are not applicable to this type of submission.
Here's an attempt to answer the relevant aspects based on the provided text, while clearly indicating where information is not available or not applicable:
Acceptance Criteria and Device Performance for STA®-vWF Control [N]+[P] Kit
This submission describes a control kit, not a diagnostic device with performance metrics related to diagnostic accuracy. The "acceptance criteria" and "device performance" in this context refer to the product's ability to serve its intended function as a quality control.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Intended Use | Provides two citrated human plasmas for use as normal and abnormal controls for vWF antigen assays by immuno-turbidimetric method on the STA® analyzer. | The description confirms the kit contains these components for this purpose. |
| vWF Value Assignment | Each manufactured lot is assigned vWF values (normal and abnormal levels). | This process is described. |
| vWF Value Referencing | vWF values are determined with an internal WF reference that has been assayed against the third International Standard 91/666 for Factor VIII and von Willebrand Factor (1992). | This establishes traceability to an international standard. |
| Kit Contents | 12 x 1-ml vials of freeze-dried plasma (normal level) and 12 x 1-ml vials of freeze-dried plasma (abnormal level). | This matches the product description. |
| Shelf Stability (Freeze-dried) | Stable for 24 months after manufacture when stored at 2°-8°C. | This is explicitly stated. |
| On-board Stability (Reconstituted) | Stable for 8 hours on board the STA® analyzer after reconstitution with water. | This is explicitly stated. |
Study Details:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This is not a study evaluating a diagnostic device's performance on patient samples. Instead, it's about the quality and consistency of a control product.
- Data Provenance: Not applicable in the context of a diagnostic performance study. The "data" pertains to the characterization and stability of the control plasma itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context relates to the assigned vWF values and stability characteristics, which are determined through laboratory testing and referencing, not expert consensus on patient interpretations.
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Adjudication method for the test set:
- Not applicable. There is no "adjudication" of patient results or interpretations involved.
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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 a diagnostic device, and therefore no human-in-the-loop AI studies would be relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
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The type of ground truth used:
- For the vWF value assignment, the "ground truth" is established by referencing against the third International Standard 91/666 for Factor VIII and von Willebrand Factor (1992).
- For stability, the ground truth is established through laboratory testing to determine the duration the product maintains its specified characteristics under defined storage conditions.
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The sample size for the training set:
- Not applicable. This is not a machine learning or algorithmic device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.