(67 days)
The Emit® II Plus Amphetamines Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff, 500 ng/mL cutoff or a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Amphetamines Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
The Emit® II Plus Amphetamines Assay is a homogeneous enzyme immunoassay for the qualitative and semiquantitative analysis of amphetamines in human urine.
Here's an analysis of the provided text regarding the Syva® Emit® II Plus Amphetamines Assay, broken down by your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the reported "Percent agreement" with the reference method (GC/MS). While a specific pre-determined threshold for acceptance isn't explicitly stated as "acceptance criteria," the goal is to show a high agreement.
| Cutoff Level | Acceptance Criteria (Implied) | Reported Device Performance (Percent Agreement with GC/MS) |
|---|---|---|
| 300 ng/mL | High agreement with GC/MS | 97% |
| 500 ng/mL | High agreement with GC/MS | 96% |
| 1000 ng/mL (vs. GC/MS) | High agreement with GC/MS | 86% |
| 1000 ng/mL (vs. Predicate Device) | High agreement with predicate device | 97% |
Note: For the 1000 ng/mL cutoff, there are two comparisons: one against GC/MS and one against the predicate device (Syva® Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay). Both are listed in the table.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 124 urine specimens were used for method comparison studies for each cutoff level (300 ng/mL, 500 ng/mL, and 1000 ng/mL).
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective. Given that specimens were "obtained" and then analyzed by both the proposed device and GC/MS, it is likely a retrospective analysis of collected urine samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) which is a laboratory analytical method, not typically performed by "experts" in the clinical sense (e.g., radiologists). The document does not describe who performed the GC/MS analysis or their qualifications.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication typically refers to resolving discrepancies between multiple human readers or between a human reader and an AI. In this study, the primary ground truth is established by an objective analytical method (GC/MS), and the device's results are compared directly to that. There is no mention of human readers or a need for adjudication among them. Discrepancies between the device and GC/MS are reported and sometimes further analyzed semiquantitatively.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay designed to provide a chemical analysis of urine, not to assist human readers in interpreting images or clinical data. Therefore, there's no "human readers improve with AI vs without AI assistance" aspect to evaluate.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, a standalone performance study was done. The Syva® Emit® II Plus Amphetamines Assay is an automated enzyme immunoassay performed on a chemistry analyzer (Syva®-30R Biochemical System). The results presented are the direct output of this automated system compared to the reference method (GC/MS), without any human interpretation of the assay results before comparison. It functions as an "algorithm only" in the context of an IVD.
7. Type of Ground Truth Used
The type of ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered a highly specific and sensitive reference method for confirming the presence and concentration of substances in biological samples, making it an objective and reliable ground truth for in vitro diagnostic assays like this.
8. Sample Size for the Training Set
The document does not specify a discrete "training set" sample size. For an IVD assay, the development process involves optimization and calibration, which would use various samples, but this is not typically reported as a "training set" in the same way machine learning models report it. The reported studies are for performance validation rather than model training.
9. How the Ground Truth for the Training Set Was Established
Since a distinct "training set" with established ground truth as per common AI/ML terminology is not explicitly mentioned or described for this IVD, this information is not provided. The development of the assay itself would involve internal studies and verification cycles, likely using methods such as GC/MS to establish the reference values for calibrators and controls used in the assay.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).