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The CEDIA® Multi-Drug OFT Calibrators are intended for use in the calibration of d-Amphetamine, Benzoylecgonine, Morphine and Phencyclidine (PCP) in human Oral Fluid when used with the CEDIA Amphetamine, Cocaine, Opiate, and Phencyclidine (PCP) OFT Assays on the MGC 240 analyzer. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA® Multi-Drug OFT Calibrators are liquid ready-to-use. They are prepared by spiking known quantities of Amphetamine, Benzoylecgonine, Morphine and PCP in to buffer matrix. The Cutoff Calibrator is used as a qualitative cutoff reference for distinguishing "positive" from "negative" samples. The concentration for each drug in the calibrators is listed in table below. Concentrations for each calibrator are confirmed by LC-MS/MS methodology.

The provided text describes a 510(k) submission for the CEDIA® Multi-Drug OFT Calibrators, focusing on its substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The document primarily focuses on:

• Intended Use: Calibration of specific drugs (d-Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (PCP)) in human Oral Fluid when used with CEDIA OFT Assays on the MGC 240 analyzer.
• Device Description: Liquid, ready-to-use calibrators prepared by spiking known quantities of drugs into a buffer matrix. Concentrations are confirmed by LC-MS/MS.
• Comparison to Predicate Device: Table outlining similarities and differences in intended use, analytes, matrix, form, calibrator levels, and storage temperature.
• Conclusion: Substantial equivalence due to performance testing verifying intended function and satisfaction of design specifications.

Therefore, based on the provided text, I cannot provide answers to the requested information (1-9) as they pertain to performance acceptance criteria and efficacy studies typically found in clinical validation reports for diagnostic devices.

The document states: "Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied." However, it does not provide any details about this "performance testing," including:

• Specific acceptance criteria: What quantitative thresholds were set for performance?
• Performance results: What were the reported metrics (e.g., accuracy, precision, bias)?
• Study design details: Sample size, data provenance, ground truth establishment, expert involvement, etc.

Without this information, it's impossible to fill in the requested table or answer the subsequent questions about the study. This document appears to be just the 510(k) summary and the FDA's clearance letter, not the detailed performance study report itself.

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