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LiniCAL™ hsCRP Calibration Verifiers Levels A – E for the Dade BN™II Nephelometer is intended for use as an assayed quality control material for analysis.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "LiniCAL™ hsCRP Calibration Verifiers Levels A – E for the Dade BN™II Nephelometer." This document does not contain information about acceptance criteria, study details, or performance data of the device.

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 marketed in interstate commerce prior to May 28, 1976..."

This indicates that the FDA's approval is based on substantial equivalence to a predicate device, rather than a new study demonstrating performance against specific acceptance criteria.

Therefore, I cannot provide the requested information. The document is missing all points you asked for, including:

• A table of acceptance criteria and the reported device performance: Not present.
• Sample sized used for the test set and the data provenance: Not present.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
• Adjudication method for the test set: Not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
• If a standalone performance study was done: Not present.
• The type of ground truth used: Not present.
• The sample size for the training set: Not present.
• How the ground truth for the training set was established: Not present.

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