(177 days)
VERDICT -II OPIATES 2000 is a one-step immunochromatographic test for the rapid, qualitative detection of opiates (morphine and/or codeine) in human urine. The test detects opiates and their major metabolites at the cut-off concentration of 2000ng/mL. It is not for overthe-counter sale.
VERDICT®-II OPIATES 2000 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, particularly when preliminary positive results are used.
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Here's an analysis of the provided FDA document regarding the VERDICT®-II OPIATES 2000 device, focusing on acceptance criteria and study details:
This document, an FDA 510(k) clearance letter, primarily establishes that the VERDICT®-II OPIATES 2000 device is substantially equivalent to a legally marketed predicate device. It does not contain detailed information about specific acceptance criteria or a comprehensive study report designed to prove the device meets those criteria with a specified performance metric.
The document does describe the device's intended use and the concentration it detects, which implicitly sets a functional performance expectation.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of sensitivity, specificity, accuracy percentages, or other statistical measures. Instead, it defines the functional capability of the device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Rapid, qualitative detection of opiates (morphine/codeine) | The device is a one-step immunochromatographic test for rapid, qualitative detection of opiates. |
| Detection in human urine | The device detects opiates in human urine. |
| Detection at a cut-off concentration of 2000 ng/mL | The device detects opiates and major metabolites at a cut-off of 2000 ng/mL. |
| Preliminary analytical test result | The device provides only a preliminary analytical test result. |
| Not for over-the-counter sale | Explicitly stated "Not for over-the-counter sale." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available. The 510(k) clearance letter does not describe the specific study data (sample size, provenance) used by the manufacturer to demonstrate substantial equivalence. This information would typically be in the full 510(k) submission, not in the FDA's clearance letter.
3. 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 available. The document does not provide details about clinical studies, expert involvement, or the qualifications of such experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not available. Since it's an in-vitro diagnostic test for drug detection and not an image-based diagnostic, adjudication methods like N+1 are not typically used in the same way. The document does not describe any specific adjudication process.
5. 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. This device is an immunochromatographic test, not an AI-assisted diagnostic device that would involve human readers interpreting AI output. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The VERDICT®-II OPIATES 2000 is an in-vitro diagnostic test. Its performance is evaluated as a standalone product. While the result is "preliminary" and requires confirmation, the device itself operates without continuous human intervention during the test run. The "standalone" performance would be its accuracy, sensitivity, and specificity in detecting opiates at the specified cut-off, although these metrics are not provided in this document.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document states: "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."
This strongly implies that GC/MS is the gold standard (ground truth) for confirming the presence and concentration of opiates.
8. The sample size for the training set
Not available. This device is not an AI/machine learning product that undergoes "training." Its performance is based on the inherent chemical and immunological properties of its components.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).