(64 days)
The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous drugs-of-abuse enzyme immunoassay with 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 Monoclonal Amphetamine/Methamphetamine 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 Syva Emit® II Plus Monoclonal Amphetamine/ Methamphetamine Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of amphetamines urine.
Here's the breakdown of the acceptance criteria and study information for the Syva Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Comparative Analysis | Complete agreement with predicate method (qualitative) | "Complete agreement in finding samples negative and positive" |
| Qualitative Spiked Sample Recovery | Correctly identify negative (≤ 750 ng/mL) and positive (≥ 1250 ng/mL) spiked specimens at +/- 25% of cutoff (1000 ng/mL) | "Correctly identified the spiked specimens as being negative and positive" |
| Semiquantitative Spiked Sample Recovery | Recovery within a certain percentage of nominal concentrations for d-methamphetamine (500 to 1800 ng/mL range) | "Recovery ranged up to ± 9% of nominal concentrations of spiked analyte" |
| Qualitative Precision (Within-run) | Acceptable coefficient of variation (CV) | 0.4% CV |
| Qualitative Precision (Total) | Acceptable coefficient of variation (CV) | 0.7 - 0.9% CV |
| Semiquantitative Precision (Within-run) | Acceptable coefficient of variation (CV) | 1.2 - 1.9% CV |
| Semiquantitative Precision (Total) | Acceptable coefficient of variation (CV) | 2.4 - 4.3% CV |
| Sensitivity | Be able to distinguish amphetamines from 0 ng/mL with 95% confidence | Less than 500 ng/mL |
Study Details
The provided document describes a standalone, in-vitro diagnostic assay and its performance testing to demonstrate substantial equivalence to a predicate device.
2. Sample Sizes used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the total number of samples (e.g., individual urine specimens) used in the comparative analysis, spiked sample recovery, or precision studies. It mentions "samples" and "specimens" without providing a specific count.
- Data Provenance: The studies were conducted using "human urine" and "negative human urine specimens" which were then spiked. The country of origin for the data is not specified, but the manufacturer is based in San Jose, CA, USA, suggesting the studies were likely conducted in the USA. The data is retrospective in the sense that real-world patient data was not prospectively collected for this specific device evaluation; rather, spiked samples and existing controls were used.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is an in-vitro diagnostic device that measures chemical concentrations. The "ground truth" for the test set was established by the known concentrations of spiked analytes in the samples, or by comparison to a predicate device, rather than through expert human interpretation.
4. Adjudication method for the test set:
- Not Applicable. As this is an assay measuring chemical concentrations, there is no human adjudication process involved in establishing the ground truth for the test set.
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 is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. This entire evaluation focuses on the standalone performance of the assay (the chemical analysis device). It inherently operates without human-in-the-loop performance in the interpretation of the initial chemical reaction, providing a quantitative or qualitative result directly.
7. The type of ground truth used:
- The ground truth for most of the reported studies was based on:
- Known concentrations of spiked analytes: For qualitative and semiquantitative spiked sample recovery, the ground truth was the precisely known amount of d-methamphetamine added to the urine samples.
- Predicate device comparison: For the comparative analysis, the ground truth was the result obtained from the legally marketed Syva Emit® II Monoclonal Amphetamine/Methamphetamine Assay. This serves as a reference standard.
- Defined cutoffs/controls: For precision, the ground truth was derived from the expected values of control materials and cutoff calibrators.
8. The sample size for the training set:
- Not Applicable. This is an enzyme immunoassay, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense. The assay's performance is based on its chemical and enzymatic reactions, not on being trained on a dataset.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).