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The 3 Panel TCA/BAR/BZO is a one-step immunochromatographic test for the rapid, qualitative detection of tricyclic antidepressants, barbiturates and benzodiazepines and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations:
Tricyclis antidepressants (Desipramine) - 50 ng/ml
Barbiturates (Phenobarbital)-200 ng/ml
Benzodiazepines (Nordiazepam)-300 ng/mL
This product is not for over-the-counter-sale
The 3 Panel provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result

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I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as requested by the user. The document is a 510(k) clearance letter from the FDA for a device named Profile® -ER TCA/BAR/BZO, along with its indications for use statement. While it mentions cutoff concentrations for detected substances, it does not outline specific acceptance criteria for a study, nor does it describe the study itself.

Therefore, I cannot extract any of the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. Whether a multi reader multi case (MRMC) comparative effectiveness study was done or its effect size
6. Whether a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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