(70 days)
The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Monoclonal Cocaine Metabolite 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-ofabuse test result, particularly when preliminary positive results are used.
Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay for qualitative and semi-quantitative analysis of cocaine metabolite (benzoylecgonine) in human urine.
Here's a breakdown of the acceptance criteria and study information for the Syva Company - Dade Behring Inc. Emit® II Plus Cocaine Metabolite Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (150 ng/mL Cutoff) | Reported Device Performance (300 ng/mL Cutoff) |
|---|---|---|
| High agreement with GC/MS (reference method) for qualitative results | 93% agreement with GC/MS | 94% agreement with GC/MS |
Note: The document does not explicitly state numerical acceptance criteria, but demonstrates a high percentage agreement with the Gas Chromatography/Mass Spectrometry (GC/MS) method, implying that high concordance is the de facto acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
- 150 ng/mL Cutoff: The number of samples is not explicitly stated, but the provided table shows:
- 2 samples testing positive by GC/MS (123 and 140 ng/mL) but negative by the device.
- 7 samples testing positive by GC/MS (150, 151, 157, 162, 164, 166, and 190 ng/mL) and positive by the device.
- The total number of samples where an agreement or disagreement is reported (excluding the header rows) is 9. However, the full sample size for the agreement percentage calculation is not provided.
- 300 ng/mL Cutoff: The number of samples is not explicitly stated, but the provided table shows:
- 6 samples testing positive by GC/MS (218, 241, 261, 294, 295, and 298 ng/mL) but negative by the device.
- 1 sample testing positive by GC/MS (354 ng/mL) and positive by the device.
- Similar to the 150 ng/mL cutoff, the full sample size for the agreement percentage calculation is not provided, only the cases of disagreement and agreement mentioned.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable for this type of device. The ground truth is established by a reference chemical/analytical method (GC/MS), not by human experts.
4. Adjudication Method for the Test Set
- Not applicable as the ground truth is established by a single, definitive chemical method (GC/MS), not by human interpretation or consensus that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is an in-vitro diagnostic (IVD) device for chemical analysis, not an AI-powered diagnostic imaging or interpretation device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this is a standalone device. The device's performance is measured directly against the GC/MS reference method. It performs the analysis of benzoylecgonine in human urine without human interpretation affecting the direct assay output. The text states: "The Emit® II Plus Monoclonal Cocaine Metabolite 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." This indicates the Emit® II Plus provides its own result which is then compared, and if positive, needs GC/MS for confirmation.
7. The Type of Ground Truth Used
- Reference standard/Gold Standard: Gas Chromatography/Mass Spectrometry (GC/MS) is specified as the "preferred confirmatory method" and the method against which the Emit® II Plus assay results are compared.
8. The Sample Size for the Training Set
- The document does not provide any information about a training set size. This assay is a homogeneous enzyme immunoassay, not a machine learning model that typically requires a distinct training set. The "method comparison" describes validation, not necessarily model training.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as no training set for a machine learning model is mentioned or implied.
§ 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).