(129 days)
The Immunalysis Amphetamine ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Amphetamine in oral fluid samples collected with the Quantisal™ oral fluid collection device using a cutoff of 50 ng/mL of d-Amphetamine. This in-vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Amphetamine ELISA Kit for Oral Fluids provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method . Clinical and Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
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The document provided is a 510(k) clearance letter for the Immunalysis Amphetamine ELISA for Oral Fluids device. This type of document primarily confirms that a medical device is substantially equivalent to a legally marketed predicate device. It does not typically contain detailed acceptance criteria, study methodologies, or performance results in the way that a clinical study report or a more comprehensive premarket application might.
Based on the provided text, I can extract the following limited information:
1. Acceptance Criteria and Reported Device Performance:
The document mentions a cutoff of 50 ng/mL of d-Amphetamine for qualitative detection. It explicitly states: "The Immunalysis Amphetamine ELISA Kit for Oral Fluids provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method."
This implies that the "acceptance criteria" for the device's performance in this context is its ability to provide a preliminary screen for amphetamine at or above the 50 ng/mL cutoff, and acknowledged that confirmation by a more definitive method (GC-MS) is required for a conclusive result.
The document does not provide a table of specific analytical performance metrics (e.g., sensitivity, specificity, accuracy, precision) or a direct comparison to acceptance criteria values.
2. Sample Size and Data Provenance:
- Test set sample size: Not specified in the provided text.
- Data provenance: Not specified in the provided text.
3. Number and Qualifications of Experts for Ground Truth:
- Not applicable/Not specified. This is an analytical device, not an interpretation device that would involve expert readers for ground truth establishment.
4. Adjudication Method for Test Set:
- Not applicable/Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This device is an immunoassay for detecting amphetamine, not an imaging or diagnostic interpretation device that would involve human readers.
6. Standalone (Algorithm Only) Performance:
- Yes, the device is designed to operate in a standalone manner to provide a preliminary analytical result. The performance is the output of the ELISA assay. However, the exact performance metrics are not described in this document.
7. Type of Ground Truth Used:
- While not explicitly stated for the "study" itself in this document, the industry standard for confirming positive drug screens from such devices is Gas Chromatography/Mass Spectrometry (GC-MS), which the document also identifies as the "preferred confirmatory method." GC-MS is an objective, highly specific, and sensitive analytical method considered the gold standard for drug confirmation. Therefore, the ground truth for this type of device's performance evaluation would typically be established by comparing ELISA results to GC-MS results from the same samples.
8. Sample Size for Training Set:
- Not specified in the provided text.
9. How Ground Truth for Training Set Was Established:
- Not specified in the provided text. For an ELISA assay, the "training set" might refer to samples used during assay development and optimization, where ground truth would also be established by reference methods like GC-MS.
Summary of missing information from the provided document:
The provided 510(k) clearance letter focuses on regulatory approval and substantial equivalence. It does not include the detailed performance data, study design, sample sizes, or specifics of ground truth establishment that would typically be found in a full clinical or analytical study report. This kind of information would typically be part of the 510(k) submission itself, but is not extracted into the public-facing clearance letter.
§ 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).