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The Synermed® Total Billirubin reagent is intended for use in the quantitative determination of total bilirubin in serum or plasma. The reagent kit is intended for in vitro diagnostic use only.

Elevated serum biliruhin levels are observed in a variety of conditions including hemolytic disorders, biliary obstruction, cholestasis, hepatitis, cirrhosis and decreased conjugation (e.g. neonatal jaundice).

Total Bilirubin Reagent Kit

I am sorry, but the provided text from the FDA letter for the Synermed Total Bilirubin Reagent Kit (K972716) is a clearance letter and does not contain the detailed information required to describe acceptance criteria and a study proving device effectiveness. The letter confirms substantial equivalence to a legally marketed predicate device but does not provide performance data, study design, or ground truth establishment.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. Multi Reader Multi Case (MRMC) comparative effectiveness study results or effect size
6. Standalone algorithmic performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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