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These kits are intended for separation and quantitations of serum proteins using agarose gel electrophoresis on the REP and REP 3 Analyzer.

This test can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflammatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias and genetic deficiencies.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA for a device, the REP SPE Vis-60/40 Kit, and does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to a pre-amendments device and can be marketed.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The 510(k) letter confirms the device's regulatory pathway and its intended use for "separation and quantitations of serum proteins using agarose gel electrophoresis on the REP and REP 3 Analyzer" to assist in diagnosing various disease states. However, it does not include the detailed performance study information you are asking for.

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