(45 days)
The Emit® II Plus Monoclonal 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-of-abuse test result, particularly when preliminary positive results are used.
Emit® II Plus Monoclonal Cocaine Metabolite Assay is a homogeneous enzyme immunoassay for qualitative and semi-quantitative analysis of cocaine metabolite (benzoylecgonine) in human urine.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Emit® II Plus Monoclonal Cocaine Metabolite Assay:
Acceptance Criteria and Device Performance
The provided document describes a method comparison study to demonstrate substantial equivalence to a legally marketed predicate device (Emit® II Plus Cocaine Metabolite Assay). The primary acceptance criterion appears to be a high percentage agreement between the new device and the comparative method.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance (150 ng/mL Cutoff) | Reported Device Performance (300 ng/mL Cutoff) |
|---|---|---|
| High Percent Agreement with Comparative Method | 96% | 98% |
Study Details
Here's a breakdown of the study that proves the device meets the acceptance criteria:
-
A table of acceptance criteria and the reported device performance:
See table above.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: 110 samples for both the 150 ng/mL cutoff and the 300 ng/mL cutoff analyses.
- Data Provenance: The document does not specify the country of origin. It also doesn't explicitly state whether the samples were collected retrospectively or prospectively. However, given it's a method comparison for a new assay, it's most likely that a set of existing or collected samples were used for retrospective analysis.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- The document does not specify the number of experts or their qualifications. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method, not human expert consensus.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- There was no human "adjudication" in the traditional sense, as the ground truth was determined by GC/MS. The Emit® II Plus Monoclonal Cocaine Metabolite Assay results were compared against the Emit® II Plus Cocaine Metabolite Assay results, with GC/MS serving as the gold standard for confirmation, particularly for discrepancies.
-
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:
- No. This study is for an in-vitro diagnostic (IVD) immunoassay, not an AI-powered diagnostic imaging device or a system requiring human interpretation. Therefore, an MRMC study and human reader improvement due to AI assistance are not applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the Emit® II Plus Monoclonal Cocaine Metabolite Assay. The device is a homogeneous enzyme immunoassay, which provides a direct output result without human interpretive input for the primary analytical test. The results were then compared to a legally marketed predicate device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for confirmation was Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "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." For the samples identified as false negatives by the new assay, GC/MS results confirmed the presence of benzoylecgonine at specific concentrations.
-
The sample size for the training set:
- The document does not provide information about a separate "training set" or its size. This is common for conventional immunoassay development, where a "training set" in the machine learning sense is not typically used. The development of the assay itself would have involved laboratory optimization and characterization rather than a distinct training phase on a dataset of clinical samples.
-
How the ground truth for the training set was established:
- As no specific "training set" is mentioned in the context of this 510(k) submission for an immunoassay, the establishment of ground truth for such a set is not described. The assay's performance characteristics are established through analytical validation and method comparison using samples with known concentrations confirmed by a gold standard like GC/MS.
§ 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).