(99 days)
The STC Cocaine Metabolite Micro-Plate EIA is intended for use in the qualitative determination of cocaine and cocaine metabolites in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.
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Below is an analysis of Acceptance Criteria and the study from the provided document.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or a detailed performance table. However, it does indicate the device is intended for "qualitative determination of cocaine and cocaine metabolites in oral fluid." The FDA's letter states the device is "substantially equivalent" to predicate devices. This implies that its performance is considered acceptable based on comparison to existing, legally marketed devices.
To infer potential acceptance criteria and reported performance, we can assume that "substantial equivalence" in a qualitative test means the device demonstrated comparable accuracy (sensitivity and specificity) to a predicate device for detecting cocaine metabolites in oral fluid. Without the specific predicate device or the detailed 510(k) submission, we cannot provide exact numbers.
Inferred Table:
| Performance Metric | Acceptance Criteria (Inferred from Substantial Equivalence to a Qualitative Test) | Reported Device Performance (Inferred from FDA Clearance) |
|---|---|---|
| Qualitative Detection of Cocaine Metabolites in Oral Fluid | Comparable Sensitivity to Predicate Device | Deemed Sufficient for "Substantial Equivalence" |
| Qualitative Detection of Cocaine Metabolites in Oral Fluid | Comparable Specificity to Predicate Device | Deemed Sufficient for "Substantial Equivalence" |
2. Sample Size for the Test Set and Data Provenance:
The provided documents (FDA 510(k) clearance letter and Indications for Use statement) do not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the 510(k) submission itself, which is not included here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. For a qualitative diagnostic device detecting drug metabolites, the ground truth would likely be established through a confirmatory test method (e.g., GC/MS), not strictly by human expert consensus on interpretations of the initial test.
4. Adjudication Method for the Test Set:
Given the nature of a qualitative test for drug metabolites, an adjudication method like 2+1 or 3+1 typically used for image interpretation or subjective assessments is unlikely to be directly applicable. The ground truth would most probably be established by an objective, gold-standard laboratory method. The document does not specify any adjudication method used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study (comparing human readers with and without AI assistance) is not applicable and was not performed/reported for this device. This device is an "in vitro diagnostic" (IVD) test, specifically a micro-plate EIA for qualitative determination. It's a laboratory test, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
This device is an "in vitro diagnostic" (IVD) kit. Its performance, as an EIA (Enzyme Immunoassay), is inherently standalone in the sense that the assay itself produces a result (e.g., optical density reading) which is then interpreted against a cut-off to determine a qualitative positive or negative. There isn't an "algorithm only" component separate from the physical assay. The study would have focused on the performance of the entire assay system (reagents, plates, reader, interpretation) in detecting the target analyte.
The FDA's "substantial equivalence" determination implies that the standalone performance of the device was found to be comparable to predicate devices. However, the document does not detail the specific standalone performance study.
7. Type of Ground Truth Used:
While not explicitly stated in the provided text, for a device intended for "qualitative determination of cocaine and cocaine metabolites," the ground truth for performance studies would almost certainly be established by a confirmatory analytical method, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). These are considered gold-standard methods for drug detection and quantification in biological samples.
8. Sample Size for the Training Set:
The document does not provide information regarding the sample size used for the training set. For IVD devices, a "training set" in the context of machine learning (AI) is not typically applicable. If any "training" occurred, it would be related to optimization of reagents, cut-off values, or assay conditions during development, not in the sense of an AI model's training data. The primary performance evaluation would be done on independent test sets.
9. How the Ground Truth for the Training Set Was Established:
As mentioned in point 8, the concept of a "training set" with established ground truth in the AI context isn't directly applicable here. If referring to the process of developing the assay and establishing its optimal cut-off, the ground truth would again rely on a gold-standard confirmatory method (e.g., GC/MS or LC/MS) to calibrate the assay's response and set the appropriate thresholds for positive/negative results. The document does not detail this developmental process.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).