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The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include CardioImmune® TL with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

The MAS® CardioImmune® proBNP is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include CardioImmune® proBNP with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

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This is a 510(k) premarket notification for a Class I quality control material. Typically, for this type of device, substantial equivalence is established by demonstrating that the device has the same intended use and similar technological characteristics as a predicate device, and does not raise different questions of safety and effectiveness.

The provided document (K032335) does not contain the information requested regarding acceptance criteria studies, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. These types of detailed performance studies are generally not required for Class I quality control materials where the regulatory path focuses on substantial equivalence to existing devices.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This confirms the basis of the clearance.

Therefore, I cannot provide the requested information from the given text.

Summary of what can be inferred or is missing:

1. Table of acceptance criteria and reported device performance: Not provided. The document is a clearance letter, not a study report.
2. Sample size used for the test set and data provenance: No test set information is provided as this is not a study report.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable/Not provided.
4. Adjudication method for the test set: Not applicable/Not provided.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted/Not reported for this type of device.
6. Standalone performance study: Not reported. The clearance is based on substantial equivalence, not a detailed performance study like what would be seen for a diagnostic algorithm.
7. Type of ground truth used: Not applicable/Not provided. For quality control materials, "ground truth" often refers to assigned values established by reference methods or validated consensus processes, but details are not in this document.
8. Sample size for the training set: Not applicable/Not provided. There is no mention of a training set as this is not an AI/ML algorithm device.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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