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The MICRO-STRIP FOR MARIJUANA METABOLITES is an immunoassay that qualitatively detects the major Marijuana metabolites (tetrahydrocannabinoids/THC) in urine at the SAMHSA cutoff level of 50 ng/m1. The MICRO-STRIP FOR MARIJUANA METABOLITES is Intended for use by clinical toxicology laboratories, physician offices, drug abuse clinics and law enforcement agencies only.

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This is a 510(k) premarket notification for "MICRO-STRIP FOR MARIJUANA METABOLITES", an immunoassay for qualitatively detecting major marijuana metabolites (tetrahydrocannabinoids/THC) in urine at the SAMHSA cutoff level of 50 ng/ml. The document explicitly states that the device is intended for use by clinical toxicology laboratories, physician offices, drug abuse clinics, and law enforcement agencies. This FDA letter approves the device, meaning it was found substantially equivalent to a predicate device. Often, 510(k) summaries, not the approval letter itself, contain detailed study information. The provided text is an approval letter, not the full submission. Therefore, much of the requested detailed study information is not available in the provided text.

However, based on the nature of the device (an immunoassay detecting a specific metabolite at a cutoff level), we can infer certain aspects of the acceptance criteria and study design, even if the explicit details are missing.

Here's an attempt to answer the questions based on the available information and general knowledge of such devices, highlighting what is directly stated, inferred, or not present.

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA letter does not include a table of acceptance criteria or specific reported device performance metrics. Such information would typically be found in the 510(k) summary or the full submission, not in the FDA's approval letter.

However, for a qualitative immunoassay like this, the primary performance metrics would likely revolve around:

• Sensitivity: The ability of the test to correctly identify samples containing marijuana metabolites at or above the 50 ng/ml cutoff.
• Specificity: The ability of the test to correctly identify samples not containing marijuana metabolites above the 50 ng/ml cutoff, or to not react with interfering substances.
• Cutoff Performance: Accurate classification of samples around the 50 ng/ml threshold.
• Reproducibility/Precision: Consistency of results when tested multiple times.
• Cross-reactivity: Assessment against various prescription and over-the-counter drugs, as well as structurally similar compounds, to ensure no false positives.

Inferred Acceptance Criteria (Typical for such devices):

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