(132 days)
'RapidOne'-Methadone Test is a one-step, lateral flow immunoassay for the detection of methadone in urine.
'RapidOne'-Methadone Test is intended for the qualitative detection of methadone in human urine at 300 ng/ml.
'RapidOne'-Methadone Test is intended for professional use. It is not intended for over the counter sale to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).
'RapidOne'-Methadone Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particulary when preliminary results are used.
The assay employed in the 'RapidOne'-Methadone' Test is based on the same principle of highly specific reaction between antigens and antibodies.
This assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug that may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of a membrane. In the absence of any drug in the urine sample, the colloidal goldantibody moves with the urine by capillary action to contact the immobilized drug coniugate. An antibody-antigen reaction occurs forming a visible line in the 'test' area. The formation of a visible line in the 'test' area occurs when the test is negative.
When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-antibody complex. If sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result.
A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The 'control; line is not influenced by the presence or absence of drug in the urine, and therefore, should be present in all reactions.
This document describes the 'RapidOne'-Methadone Test, an immunoassay for the qualitative detection of methadone in human urine, and its performance characteristics as submitted for 510(k) clearance.
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the 'RapidOne'-Methadone Test is its ability to detect methadone at a concentration of 300 ng/ml in urine, and its performance relative to a predicate device and confirmatory GC/MS testing. The reproducibility study further quantifies its performance at concentrations above and below this cut-off.
| Acceptance Criteria/Metric | Reported Device Performance |
|---|---|
| Detection of methadone | The device "will detect 300 ng/ml of methadone in urine." |
| Concordance with predicate device & GC/MS | - All 50 drug-free samples were correctly identified as negative by both 'RapidOne' and the predicate device. |
- Out of 40 Syva Emit II positive samples (confirmed and quantified by GC/MS from 146 to 1072 ng/ml), both 'RapidOne' and the predicate device correctly identified all as positive. |
| Reproducibility (at cut-off and surrounding concentrations) | No drug (0 ng/ml): 120/120 Negative (100%)
150 ng/ml (below cut-off): 6 Positive, 114 Negative (95% negative)
225 ng/ml (near cut-off): 106 Positive, 14 Negative (88.3% positive)
375 ng/ml (above cut-off): 120 Positive, 0 Negative (100% positive) |
Note: The reproducibility table's "RDS Result" column is missing a header for the two sub-columns, but based on context, it appears to represent "Number of Positive" and "Number of Negative" results respectively for each concentration.
2. Sample Size and Data Provenance
- Test Set Size: 90 samples were used for the comparison study with the predicate device and GC/MS. This included 50 drug-free samples and 40 positive samples. For the reproducibility study, 120 replicates were tested at each of four concentrations (total 480 tests).
- Data Provenance: Not explicitly stated (e.g., country of origin). The data appears to be retrospective, as samples were "selected for evaluation" and had already been tested by Syva Emit II and quantified by GC/MS.
3. Number of Experts and Qualifications for Ground Truth for Test Set
- The document does not mention the use of experts to establish ground truth for the test set. Instead, it relies on a confirmatory analytical method, GC/MS, to establish the definitive presence and concentration of methadone in the positive samples.
4. Adjudication Method for the Test Set
- No adjudication method by human experts is described for the test set. The direct comparison is made between the 'RapidOne' device, the predicate device, and the GC/MS results (for positive samples). For negative samples, the "drug-free" status appears to be the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was performed or described. The study focuses on the device's performance against a predicate and a gold standard analytical method, not on human reader improvement with or without AI assistance. The device is a "RapidOne"-Methadone Test, an immunoassay, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance was done. The entire study describes the performance of the 'RapidOne'-Methadone Test device itself, without human-in-the-loop assistance. Operators administered the test according to its instructions and recorded the results.
7. Type of Ground Truth Used
- For positive samples: The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is explicitly mentioned as the preferred confirmatory method. The positive specimens were "confirmed as positive and quantified by GC/MS."
- For negative (drug-free) samples: The ground truth was based on the samples being "found to be drug-free," implying a prior determination that those samples contained no drug. The method for this initial finding is not detailed but is assumed to be a reliable screening method or known origin.
8. Sample Size for the Training Set
- The document does not describe a "training set." This type of in vitro diagnostic device (immunoassay) typically does not involve a machine learning model that requires a distinct training and test set in the same way an AI/ML algorithm would. The development of the assay itself is an iterative process, but the provided documentation focuses on its validation.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a traditional "training set" for an AI/ML model, this question is not applicable to the provided information. The development of the immunoassay involves chemical and biological principles rather than algorithm training on data.
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).