(104 days)
Verdict®-II THC/COC/OPI/MAMP-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids, opiates, cocaine, methamphetamine (MAMP), and 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations:
Cannabinoids (11 nor-9-carboxy-Δ 9 -THC)-50 ng/ml
Opiates (morphine)-300 ng/ml
Cocaine (benzoylecgonine)-300 ng/mL
Methamphetamine (MAMP)-1000 ng/mL
3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL
This product is not for over-the-counter-sale
Verdict®-II 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
Not Found
This is an FDA 510(k) clearance letter for the Verdict®-II THC/OPI/COC/MAMP-MDMA, a rapid, qualitative immunochromatographic test for the detection of various drugs and their metabolites. The provided document details the indications for use but does not contain the specific study data, acceptance criteria, or performance metrics typically requested for a device.
Therefore, many of the requested items cannot be extracted directly from this document.
However, I can extract the indication for use and the cut-off concentrations, which are fundamental to understanding the device's intended performance.
Acceptance Criteria and Reported Device Performance (Based on provided information):
The document defines the cut-off concentrations for detecting the major metabolites of the specified drugs. While it doesn't explicitly state "acceptance criteria" in a table format, these cut-off levels inherently define the performance target for the device's qualitative detection. It does not provide data on the device's actual performance against these cut-offs (e.g., sensitivity, specificity, accuracy).
| Analyte (Metabolite) | Cut-off Concentration (ng/ml) | Reported Device Performance (N/A – not in document) |
|---|---|---|
| Cannabinoids (11 nor-9-carboxy-Δ⁹-THC) | 50 | Not provided |
| Opiates (morphine) | 300 | Not provided |
| Cocaine (benzoylecgonine) | 300 | Not provided |
| Methamphetamine (MAMP) | 1000 | Not provided |
| 3,4-methylenedioxymethlyamphetamine (MDMA) | 1500 | Not provided |
Since the provided document is a 510(k) clearance letter, it primarily states that the device is substantially equivalent to a predicate device and provides its intended use and general characteristics. It does not include the detailed study report that would contain the specific information requested for points 2 through 9.
Therefore, for the following points, the answer is "Not provided in the document."
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided in the document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable for this type of diagnostic test (which is not an AI-assisted imaging device). Not provided in the document.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an immunochromatographic test, not an algorithm. Its performance is inherent to the chemical reaction. Not provided in the document.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document. For drug tests, ground truth typically involves a confirmatory method like GC/MS. The document specifies GC/MS as the preferred confirmatory method but doesn't detail how it was used in a study.
- The sample size for the training set: Not applicable (not an AI device). Not provided in the document.
- How the ground truth for the training set was established: Not applicable (not an AI device). Not provided in the document.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).