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Beckman Coulter's Protein Control is intended for use in monitoring the reliability and overall performance of specific protein tests systems in the clinical laboratory. The use of three levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision.

The Vigil™ Protein Controls are three level ready-to-use human serum-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 4 X 5 mL bottles of a sinale level of control.

The provided document is a 510(k) premarket notification for a medical device called "Vigil™ Protein Controls". This device is a quality control material intended for use in monitoring the reliability and performance of specific protein test systems in a clinical laboratory.

The document does not contain information regarding acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone). It is a regulatory submission for a quality control material, not a diagnostic or therapeutic device requiring such performance studies.

Therefore, I cannot provide the requested information based on the input document.

Summary of what is present in the document:

• Device Name: Vigil™ Protein Control
• Intended Use: Monitoring the reliability and overall performance of specific protein test systems in the clinical laboratory.
• Classification: Class I, Product Code JJY (Quality Control Material, assayed and unassayed, per 21 CFR § 862.1660)
• Predicate Device: Vigil PRₓ™ Controls (K936184)
• Manufacturer: Beckman Coulter, Inc.
• Regulatory Decision: Substantially Equivalent (K982224)

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