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The Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, lactate, pH, PCO2, PO2, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood.

Intended for Point-of-Care Usage

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This document is a marketing clearance letter from the FDA for a device called "STAT Profile M Analyzer," not a study report. It does not contain information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The letter confirms that the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This substantial equivalence determination is based on the information provided in the 510(k) premarket notification, but the letter itself does not detail the specific performance studies, acceptance criteria, or their quantitative results.

Therefore, I cannot provide answers to the requested information based on the provided text, as the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information about experts used to establish ground truth.
4. Adjudication methods.
5. Details of a multi-reader multi-case comparative effectiveness study or effect sizes.
6. Results of a standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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