(16 days)
The Emit® II Plus Monoclonal Amphetamine Assay is a homogeneous enzyme immunoassay with a 1000 ng/ml cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semi-quantitative analysis of amphetamines in human urine. These reagents are packaged specifically for use on a variety of Olympus® analyzers.
The Emit® II Plus Monoclonal Amphetamine 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 modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.
The provided text is a 510(k) summary for the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay. It establishes the device's substantial equivalence to a predicate device and states its intended use. However, it does not include detailed acceptance criteria, a study demonstrating performance against those criteria, or the specific information requested in the prompt regarding sample sizes, ground truth establishment, or clinical study designs.
Therefore, most of the information requested cannot be extracted from this document. The document primarily focuses on regulatory approval based on equivalence rather than presenting a performance study with detailed acceptance criteria.
Here's what can be inferred or explicitly stated from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific acceptance criteria (e.g., sensitivity, specificity thresholds) nor report detailed performance metrics against such criteria. It states that the "assay performance characteristics" are the same as the predicate device, implying that the predicate device's performance would be the reference, but no specific numbers are given.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe a new performance study with a test set. The submission is based on the device being substantially equivalent to a predicate device, with minor changes primarily related to packaging and compatibility with different analyzers.
3. 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)
- Cannot be provided. No new test set is described, so no information on experts or ground truth establishment for such a set is present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No new test set or adjudication method is described.
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
- Cannot be provided. This device is an in-vitro diagnostic (IVD) assay for drug detection, not an AI-assisted diagnostic tool that would involve human readers interpreting results in a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. While an IVD assay functions "standalone" without human interpretation in the sense of a clinical reader, the document does not present results of a standalone performance study with specific metrics. It relies on the substantial equivalence to an existing device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided for a new study. For drug-of-abuse assays, the "ground truth" for confirming positive results typically involves more specific analytical methods like Gas Chromatography/Mass Spectrometry (GC/MS). The document mentions GC/MS as the preferred confirmatory method for preliminary positive results, implying how clinical ground truth would be established for patient samples, but not for a specific device validation study described in this document.
8. The sample size for the training set
- Not applicable/Cannot be provided. This is an enzyme immunoassay, not a machine learning model. There is no concept of a "training set" in the context of this device.
9. How the ground truth for the training set was established
- Not applicable/Cannot be provided. As above, no training set.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence for a minor modification (packaging and analyzer compatibility) of an existing in-vitro diagnostic device. It does not describe or report the outcomes of a new performance study that would establish new acceptance criteria or detailed performance metrics.
§ 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).