(53 days)
Rapid Methadone Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Rapid Methadone Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Rapid Methadone Test Strip is a dipstick device for detecting the presence or absence of the tested drug. The test strip is also used for the composition of Rapid Methadone Test Card. These test devices are manufactured with the same formulation and procedure except the test card consists a plastic housing containing one methadone test strip. There is no any functional design that may affect the test strip's performance in the test card.
A. Test Strip
Test strips that containing absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, are used to assemble Rapid Methadone Test Strip as shown below:
B. Test Card Format
The above test strip that contains an absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, is used to assemble the Test Card Device as shown below.
The provided submission describes a medical device, the Rapid Methadone Test Strip and Rapid Methadone Test Card, which are immunochromatography-based one-step in vitro tests for the qualitative determination of methadone in human urine specimens above a cutoff level of 300 ng/ml.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria for accuracy, sensitivity, or specificity in the way it might for a diagnostic imaging device. Instead, it states that the devices demonstrate performance characteristics that are "substantially equivalent" to a predicate device, the Applied Biotech SureStep™ Drug Screen Test Methadone. This implies that the acceptance criteria are met if the new device's performance aligns with or is comparable to that of the predicate device.
However, based on the general understanding of drug screening tests, the primary performance metrics are Sensitivity (ability to correctly identify positive samples) and Specificity (ability to correctly identify negative samples). The document mentions "Sensitivity Accuracy" and "Specificity" in the list of studies performed.
Since specific quantitative acceptance criteria are not provided in the document, we will infer the reported device performance based on the claim of substantial equivalence to the predicate. To fully understand the acceptance criteria and corresponding performance, one would typically need access to the predicate device's performance data or a more detailed study report.
| Performance Metric | Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence) |
|---|---|---|
| Sensitivity | Comparable to predicate device (Applied Biotech SureStep™ Drug Screen Test Methadone) | Deemed substantially equivalent to predicate device |
| Specificity | Comparable to predicate device (Applied Biotech SureStep™ Drug Screen Test Methadone) | Deemed substantially equivalent to predicate device |
| Accuracy (Overall) | Comparable to predicate device (Applied Biotech SureStep™ Drug Screen Test Methadone) | Deemed substantially equivalent to predicate device |
| Precision | Consistent results as demonstrated in internal studies | Studies performed, results imply acceptable precision for substantial equivalence |
| Reproducibility | Consistent results across different tests/batches | Studies performed, results imply acceptable reproducibility for substantial equivalence |
| Stability (Specimen) | Maintenance of performance over time with stored specimens | Studies performed, results imply acceptable stability |
| Stability (Product) | Maintenance of performance over shelf-life | Studies performed, results imply acceptable stability |
| Interference | Minimal interference from common substances | Studies performed, results imply acceptable performance in presence of potential interferents |
2. Sample Size Used for the Test Set and Data Provenance
The submission states: "Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Methadone Test Strip and Rapid Methadone Test Card."
- Sample Size: The specific number of "clinical urine specimens" or "urine control specimens" used for the test set is not provided in the given text.
- Data Provenance: The provenance is "clinical urine specimen," implying human samples. The country of origin is not specified. The samples are likely retrospective as they are referred to as "clinical urine specimens" that were "tested," which typically refers to samples collected prior to the study for evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The submission states: "A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result." This indicates that Gas Chromatography/Mass Spectrometry (GC/MS) is the reference method for confirming methadone presence.
- Number of Experts: The document does not specify the number of experts.
- Qualifications of Experts: The document does not explicitly state the qualifications of individuals performing the GC/MS analysis. However, GC/MS is a laboratory-based method typically performed by trained laboratory technicians or chemists with expertise in analytical chemistry and toxicology. It's not a visually interpreted test like radiology, so "experts" in the typical sense of a clinician making a diagnosis from an image are not directly applicable here for ground truth establishment.
4. Adjudication Method for the Test Set
The adjudication method relies on a "more specific chemical method, such as GC/MS," for confirmation.
- Adjudication Method: GC/MS (or similar confirmatory chemical method) is used as the gold standard for ground truth. This is a definitive analytical process and doesn't typically involve human "adjudication" in the same way as, for example, multiple radiologists reviewing an image. Therefore, a 2+1 or 3+1 method is not applicable here. The GC/MS result is considered the definitive truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The device is an in-vitro diagnostic test strip/card, not an imaging AI device that assists human readers. Its output is a qualitative visual result (presence/absence of a colored band), not an interpretation for a human reader to improve upon.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable as it's not an AI assistance tool for human interpretation.
6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)
- Was a standalone study done? Yes, effectively. The "Rapid Methadone Test Strip" and "Rapid Methadone Test Card" are themselves standalone devices. They produce a qualitative result (presence or absence of a colored band) that is then read by a user. The performance studies listed (Sensitivity Accuracy, Specificity, Precision, Reproducibility, etc.) are evaluating the device's inherent ability to detect methadone in urine, independent of "human-in-the-loop" assistance for interpretation, beyond simply reading the test result. The "algorithm" here is the immunochromatographic reaction itself.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for confirming methadone presence is established by a "more specific chemical method, such as GC/MS." This falls under laboratory-based analytical confirmation / definitive analytical truth.
8. Sample Size for the Training Set
The document does not explicitly mention a training set for the device. Given that this is an immunochromatographic test, the "training" for such a device typically refers to the development and optimization of the reagents (antibodies, conjugates, etc.) and manufacturing processes, rather than a data-driven machine learning algorithm that requires a distinct training dataset.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is mentioned in the context of machine learning, this question is not applicable. The ground truth for developing and optimizing the assay components would have been established through controlled experiments and analytical methods, similar to how the final test set's ground truth is established (e.g., using known concentrations of methadone or GC/MS on samples).
§ 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).