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Plasma or whole blood collection device where glycolytic inhibition of the specimen is reguired.

Evacuated Blood Collection Tube Gray Stopper

The provided text describes a 510(k) clearance for an Evacuated Blood Collection Tube with a Gray Stopper (K971111). This document states the device is "substantially equivalent" to legally marketed predicate devices, which means it doesn't require a new clinical study to prove safety and effectiveness.

Therefore, the document does not contain any information about:

• Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, etc.)
• A study proving the device meets acceptance criteria
• Sample sizes for test or training sets
• Data provenance
• Number of experts or their qualifications for ground truth establishment
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used
• How ground truth for the training set was established

The document is a regulatory clearance letter, not a clinical study report. It focuses on the legal and regulatory aspects of device marketing, based on the device's equivalence to existing products rather than a new demonstration of performance through a clinical trial.

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