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MAS® UrichemTRAK Tri-Level control is intended for use in the clinical laboratory as consistent test samples of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK control with patient urine specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a quality control material (MAS® UrichemTRAK, Tri-Level Liquid Assayed Urine Control). This document does not contain information about studies proving a device meets acceptance criteria related to its performance in diagnosing or making clinical decisions. Instead, it's about the substantial equivalence determination for a quality control product, which itself is used to monitor the performance of other diagnostic assays.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies from this document.

The document discusses:

• Device Name: MAS® UrichemTRAK, Tri-Level Liquid Assayed Urine Control
• Regulation Number: 21 CFR 862.1660
• Regulation Name: Quality control material (assayed and unassayed)
• Regulatory Class: Class I
• Product Code: JJW
• Indications for Use: "MAS® UrichemTRAK Tri-Level control is intended for use in the clinical laboratory as consistent test samples of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK control with patient urine specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment." It also mentions "For in vitro diagnostic use to monitor the precision and the accuracy of chemistry systems, including the ADVIA IMS®".

This type of device is not "tested" in the same way a diagnostic algorithm or a new medical treatment device would be. Its "performance" is based on its stability and consistency in providing known concentrations, rather than diagnostic accuracy metrics like sensitivity or specificity. While the manufacturer would have internal data to ensure the quality control material itself meets manufacturing specifications, this document does not describe such studies or acceptance criteria for a diagnostic performance context.

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