(315 days)
The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device is a lateral flow competitive immunoassay intended for the qualitative detection of Methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for methamphetamine cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for methamphetamine and cause false positive results.
The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device is an immunoassay based on the principle of competitive binding. Methamphetamine which may be present in the urine specimen competes against its respective drug conjugate for binding sites on the specific antibody. The assay is a colored-latex particle, monoclonal antibody-based rapid test for the qualitative detection of Methamphetamine at a cut-off of 1000 ng/mL. The test utilizes the QuantRx patented, one step positive read, competitive immunoassay technology.
In the absence of the drug in the urine or if the amount of drug is below cut-off level, the visible test line zone (T) will show a clean negative (no signal on the test band). Drug positive specimens show a blue line in the visible test line zone (T). As an internal procedural control, a red control line appears in the control region (C) to verify that sufficient volume of sample was added and proper flow was obtained. The control line should always appear regardless of the presence of the drug if the assay has been performed properly.
Here's a breakdown of the acceptance criteria and the study details for the RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a predefined numerical target for sensitivity and specificity. Instead, the study aims to demonstrate substantial equivalence to a predicate device (ACON mAMP One Step Methamphetamine Test Strip & Test Device, K011672). The performance metrics presented are the direct results of this comparative study. Therefore, the "acceptance criteria" can be inferred to be a level of agreement with the reference method and comparable performance to the predicate device.
| Performance Metric | Reported Device Performance (RapidSense™ vs. GC/MS) |
|---|---|
| Positive Agreement | 75.0% (33/44) [95% CI: 60.6% to 85.4%] |
| Negative Agreement | 100% (40/40) [95% CI: 91.2% to 100.0%] |
| Total Agreement | 86.9% (73/84) [95% CI: 78.1% to 92.5%] |
| Comparative Performance | Showed "similar performance" to the predicate device when compared to GC/MS. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 84 specimens
- Data Provenance: The specimens were "previously collected from subjects presenting for drug testing by an external laboratory." This indicates the data is retrospective and likely originated from a clinical setting where drug testing is performed. The specific country of origin is not explicitly stated but is implied to be within the scope of the "external laboratory."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established by Gas chromatography/mass spectrometry (GC/MS), which is an analytical chemical method. Therefore, the "experts" in this context would be the specialized laboratory personnel or analytical chemists who performed and interpreted the GC/MS analysis. The document does not specify the number of individuals involved in performing the GC/MS or their specific qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
There was no human "adjudication method" in the sense of multiple human readers independently assessing the results and then resolving discrepancies. The device's results were directly compared against the GC/MS results, which served as the definitive ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study focused on the standalone performance of the RapidSense™ device against a gold standard (GC/MS) and a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 device itself is a qualitative immunoassay that provides a visual end point. The reported results (positive, negative, total agreement) are based on the direct interpretation of the device's output, without human-in-the-loop assistance for the device's reading itself. (Human technicians would apply the sample and read the results, but it's the device's intrinsic performance being measured).
7. The Type of Ground Truth Used
The type of ground truth used was analytical/confirmatory method data, specifically Gas chromatography/mass spectrometry (GC/MS). GC/MS is widely considered the gold standard for confirming drug presence and concentration.
8. The Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. This is typical for immunoassay devices, where the "training" (development and optimization) of the assay components and format is usually an internal process that occurs before formal validation studies. The reported study focuses on the validation of the finalized device.
9. How the Ground Truth for the Training Set Was Established
As no training set information is provided, there is no detail on how ground truth for any potential training set was established.
§ 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).