(97 days)
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.
Not Found
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):
| Performance Metric | Acceptance Criteria (Inferred, commonly 95% CI) | Reported Device Performance (Not provided in text) |
|---|---|---|
| Sensitivity | ≥ 95% Positive Agreement (for samples ≥ 50 ng/ml) | Not provided |
| Specificity | ≥ 97% Negative Agreement (for samples |
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).