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The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. The control is intended as a position marker for hemoglobin variant analysis methods such as ion exchange HPLC, capillary electrophoresis, cellulose acetate and agar/agarose gel electrophoresis. The Hemoglobin FASC control will assist in defining the elution time on HPLC or capillary electrophoresis or migration distance on electrophoresis. In this way the common hemoglobin variants can be identified and rare variants that elute close to these can be distinguished for further characterization.

The control is for in vitro diagnostic use only and should not be used past the expiry date.

The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. It contains stabilizers and preservatives to maintain the stability of the hemoglobin variants. The product is provided in a lyophilized form and is reconstituted with 1.0 ml of reconstitution fluid (0.09% sodium azide) prior to use.

The provided text describes a Hemoglobin FASC Variant Control (extendSURE™ HbFASC Control) and its 510(k) submission. However, it does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, or any details related to AI/algorithm performance studies.

Instead, the document focuses on:

• Device Summary: Describing the device, its intended use, and its classification.
• Predicate Device Comparison: Establishing substantial equivalence to previously cleared devices based on analyte composition and intended uses.
• Performance Characteristics (Stability): Reporting results of stability studies that support the shelf life claims.
• FDA Clearance Letter: Confirming the 510(k) clearance and the regulatory classification.
• Indications for Use: Formal statement of the device's intended applications.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies proving the device meets them, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment, as this information is not present in the provided text.

The only "performance characteristic" explicitly mentioned is:

1. A table of acceptance criteria and the reported device performance

For all other points, the information is not available in the provided text.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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: No AI component or MRMC study mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No AI component or standalone algorithm performance mentioned.
7. The type of ground truth used: Not applicable as it's a control material, and "ground truth" for a diagnostic algorithm is not relevant here. The "performance" is about its stability and ability to serve as a marker.
8. The sample size for the training set: Not applicable as it's not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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