(57 days)
The Emit® II Plus Methadone Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methadone in human urine. The Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Methadone Assay provides only a preliminary analytical test result. A more specific alternative chemical 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 Methadone Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of methadone in human urine.
Here's a breakdown of the acceptance criteria and study information for the Syva Emit® II Plus Methadone Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Qualitative Analysis (150 ng/mL cutoff) | High agreement with GC/MS (predicate) | 95% agreement with GC/MS (reference method) |
| Qualitative Analysis (300 ng/mL cutoff) | High agreement with predicate device | 100% agreement with predicate device |
| Spiked-Sample Recovery (150 ng/mL cutoff) | Consistent distinction of negative/positive above/below cutoff | Consistently distinguished negative or positive for methadone spiked at levels or = +25% of cutoff (187.5-1500 ng/mL). |
| Spiked-Sample Recovery (300 ng/mL cutoff) | Consistent distinction of negative/positive above/below cutoff | Consistently distinguished negative or positive for methadone spiked at levels or = +25% of cutoff (375-3000 ng/mL). |
| Semiquantitative Recovery (150 ng/mL cutoff) | Acceptable recovery range | Within ± 13 % of nominal concentrations |
| Semiquantitative Recovery (300 ng/mL cutoff) | Acceptable recovery range | Within ± 20 % of nominal concentrations |
| Precision (Qualitative, 150 ng/mL cutoff) | Low Coefficient of Variation (CV) | Within-run CV: 0.5-0.7%, Total CV: 1.2-1.7% |
| Precision (Qualitative, 300 ng/mL cutoff) | Low Coefficient of Variation (CV) | Within-run CV: 0.6-0.7%, Total CV: 1.5-2.1% |
| Precision (Semiquantitative, 150 ng/mL cutoff) | Low Coefficient of Variation (CV) | Within-run CV: 1.0%, Total CV: 2.3-3.0% |
| Precision (Semiquantitative, 300 ng/mL cutoff) | Low Coefficient of Variation (CV) | Within-run CV: 0.9-1.1%, Total CV: 1.6-3.7% |
| Sensitivity (150 ng/mL cutoff) | Lowest concentration distinguishable from 0 ng/mL | Less than 10 ng/mL |
| Sensitivity (300 ng/mL cutoff) | Lowest concentration distinguishable from 0 ng/mL | Less than 20 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the test set in the comparative analysis, spiked-sample recovery, or precision studies.
The data provenance is not explicitly stated beyond "human urine" samples. There is no mention of country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The ground truth method (GC/MS or predicate device) is mentioned, but not the human involvement in its establishment or interpretation.
4. Adjudication Method for the Test Set:
This information is not provided in the document, as the evaluations primarily rely on objective analytical methods (GC/MS, predicate device, and laboratory measurements) rather than subjective expert interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The device is a laboratory assay, not an imaging or diagnostic tool requiring human interpretation comparison. The comparisons are between the new assay and a reference method (GC/MS) or a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance evaluation was conducted. The device (the Emit® II Plus Methadone Assay) is an automated enzyme immunoassay that provides analytical results without direct human interpretive involvement in the "loop" of the assay's output. Its performance was assessed directly against reference methods and internal precision controls.
7. The Type of Ground Truth Used:
- For Qualitative Analysis: Gas Chromatography/Mass Spectrometry (GC/MS) is explicitly stated as the "reference method" for the 150 ng/mL cutoff. For the 300 ng/mL cutoff, the predicate device (Syva Emit® II Methadone Assay) was used as the comparative standard, implying it served as the ground truth in that comparison.
- For Spiked-Sample Recovery: Known concentrations of methadone "spiked" into negative human urine samples were used as the ground truth.
- For Semiquantitative Recovery: Similar to spiked-sample recovery, known concentrations of methadone spiked into negative human urine were used as the ground truth.
- For Precision: The ground truth for precision studies would be the expected results (e.g., control values, calibrator concentrations) against which the assay's reproducibility is measured.
8. The Sample Size for the Training Set:
The sample size for any training set is not mentioned. This type of 510(k) summary for an in vitro diagnostic assay typically focuses on validation data rather than machine learning training data.
9. How the Ground Truth for the Training Set Was Established:
As no training set is described or implied, information on how its ground truth was established is not provided. This device is a biochemical assay, not an AI/ML-based diagnostic that would typically have a distinct "training set" in the common understanding of that term.
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).