(133 days)
The Quest Diagnostics Methamphetamine Micro-Plate EIA is intended for the qualitative detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device. It is a screen test with a cutoff of 40 ng/ml.
The Quest Diagnostics Methamphetamine Micro-Plate EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
The Quest Diagnostics Methamphetamine Micro-Plate EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Methamphetamine Micro-Plate EIA to establish points of reference that are used in the determination of values in the measurement of methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.
The Ouest Diagnostics Methamphetamine Micro-Plate EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for methamphetamine in oral fluid samples collected with OraSure™ Oral Specimen Collection Device.
Quest Diagnostics Methamphetamine Micro-Plate EIA is a solid phase competitive enzyme immunoassay for the detection of Methamphetamine in oral fluid collected with the Orasure™ Oral Specimen Collection Device.
The provided text focuses on the 510(k) summary for the Quest Diagnostics Methamphetamine Micro-Plate EIA. It describes the device, its intended use, and states that it is "substantially equivalent" to a predicate device. However, this document does not contain the detailed acceptance criteria or the specific study data that would typically be presented to prove a device meets those criteria.
Generally, for a qualitative diagnostic device like this, acceptance criteria would involve sensitivity and specificity targets, often compared against a gold standard method. The study detailed would describe how these metrics were evaluated.
Based on the provided text, here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the given text. The document states that "Performance characteristic studies on precision, analytical sensitivity, interference and antibody crossreactivity showed that the Quest Diagnostics Methamphetamine Micro-Plate EIA is in substantial agreement with the Orasure Methamphetamine Intercept® Micro-Plate EIA." However, specific numerical targets for these performance metrics (e.g., "sensitivity > 95%") and the exact reported performance numbers are absent.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not explicitly provided in the given text. The document mentions "Results obtained from patient specimens," but does not specify the number of specimens, the country of origin, or if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the given text. For a device like this, the "ground truth" for methamphetamines is typically established by gas chromatography/mass spectroscopy (GC/MS), not by expert readers.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. As mentioned above, ground truth for methamphetamine detection is established by a definitive chemical method (GC/MS), not by human adjudication of images or other subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not conducted or reported. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers interpret data. For a qualitative immunoassay for drug detection, it's not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
Yes, the studies described are inherently "standalone" in the sense that they evaluate the performance of the immunoassay itself in detecting methamphetamine. The device provides a qualitative result based on chemical reactions, not human interpretation. The "Comparison Performance Data" and "Results obtained from patient specimens" refer to the intrinsic performance of the assay.
7. The Type of Ground Truth Used:
The ground truth assumed for validating drug screening tests like this is typically a confirmatory chemical method, specifically Gas Chromatography/Mass Spectroscopy (GC/MS). This is explicitly stated in the "Indications for Use Statement": "To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method."
8. The Sample Size for the Training Set:
This information is not provided in the given text. As a traditional immunoassay, there wouldn't be a "training set" in the machine learning sense. The device is developed based on known chemical reactions and antibody-antigen binding principles. The "performance characteristic studies" would involve various types of samples to characterize the device, but not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As there is no "training set" in the machine learning context for this type of device, the concept of establishing ground truth for it doesn't apply. Device development involves biochemical engineering and validation against known standards and reference methods (like GC/MS).
In summary, the provided document indicates a determination of "substantial equivalence" based on performance characteristics and patient specimen results being in "substantial agreement" with a predicate device. However, it lacks the detailed quantitative acceptance criteria and the specific study data that would demonstrate how these criteria were met for standalone performance. The focus is on comparing it to an existing, legally marketed device rather than detailing de novo performance against a strict set of predefined acceptance criteria for sensitivity, specificity, etc. This is characteristic of a 510(k) submission where substantial equivalence is the primary pathway to market.
§ 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).