(213 days)
The STA® Liatest® Control [N]+[P] kit is intended for use as control plasmas (Normal and Abnormal levels) for von Willebrand Factor (vWF) and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).
The STA®-Liatest® Control [N]+[P] kit provides two citrated human plasmas intended for use as normal and abnormal controls for von Willebrand Factor (vWF) and D-dimer antigen assays by the immino-turbidimetric method performed on STA® analyzers (Diagnostic Stago, France: STA® full-size model and STA® Compact model).
Each STA®-Liatest® Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF and D-dimer at normal levels (STA®-Liatest® Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF and D-dimer at abnormal levels (STA®-Liatest® 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 STA® analyzers.
The provided text does not contain typical acceptance criteria and study results in the format expected for medical device performance evaluation. This document is a 510(k) Premarket Notification for a control kit (STA®-Liatest® Control [N]+[P] Kit), which is used to ensure the proper functioning of other assays, specifically for von Willebrand Factor (vWF) and D-dimer antigen.
For a control kit, "acceptance criteria" usually relate to the stability and consistency of the control material itself, rather than performance metrics like sensitivity, specificity, or AI accuracy that would be expected for a diagnostic device. The provided text describes the product, its intended use, and its stability.
Here's the breakdown of what can be extracted or inferred, and what is missing based on your requested format:
What can be inferred from the provided text:
- Device: STA®-Liatest® Control [N]+[P] Kit
- Intended Use: Normal and abnormal controls for vWF and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers.
- Purpose of the "Study" mentioned (implicitly): To demonstrate the stability of the control plasmas.
What is present regarding "Acceptance Criteria" (interpreted for a control kit):
| Acceptance Criteria (Inferred from text) | Reported Device Performance (from text) |
|---|---|
| Stability (Freeze-dried state): Control plasmas should be stable for a specified duration at a given temperature. | 24 months after the date of manufacture, when stored at 2°-8°C. |
| Stability (After reconstitution): Control plasmas should be stable for a specified duration after reconstitution. | 8 hours on board STA® analyzers. |
Missing Information (as per your request, because this is for a control kit, not a diagnostic device with AI):
The following points are not applicable or not provided in the context of this 510(k) submission for a control kit:
- Sample size for the test set and data provenance: Not explicitly stated for performance validation. The "study" here is likely internal manufacturing/stability testing, not a clinical trial with a "test set" of patients.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for a control kit. Ground truth for a control kit refers to the known concentrations of its analytes, established during manufacturing.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This kit controls human readers of an assay, it is not an AI algorithm assisting human readers.
- Standalone (algorithm-only) performance: Not applicable, as this is a physical control substance, not an algorithm.
- Type of ground truth used: For a control, the "ground truth" would be the assayed values of vWF and D-dimer established during manufacturing, possibly against a reference standard. The text doesn't specify how these were established.
- Sample size for the training set: Not applicable. Control kits don't have "training sets."
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a regulatory approval for a control kit, not a performance study of a diagnostic device with AI. Therefore, most of your requested detailed study information is not available and not relevant to this specific type of device. The document primarily focuses on the product description and its stability claims.
§ 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.