(168 days)
An in vitro diagnostic test for the qualitative identification of methadone in urine. This test was calibrated against methadone at a cut-off concentration of 300 ng/ml. Measurements obtained by this device are used in screening for drug abuse.
Immunoassay for the qualitative detection of methadone in urine. The QuickScreen™ Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoasay technology.
Here's a breakdown of the acceptance criteria and study details for the QuickScreen™ Methadone Screening Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the reported performance used to demonstrate substantial equivalence to predicate devices, particularly the expectation of high agreement with established methods like EMIT II and GC/MS.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Agreement with Methadone-Positive Clinical Specimens | >99% agreement with Behring EMIT II and GC/MS | 49 out of 49 correctly identified (100% agreement) |
| Agreement with Methadone-Negative Clinical Specimens | >99% agreement with Behring EMIT II and GC/MS | 60 out of 60 correctly identified (100% agreement) |
| Overall Agreement (Independent Labs, Professional Users) | High agreement to demonstrate reliability | >98% overall agreement (47/49 positive, 60/60 negative) |
2. Sample Size Used for the Test Set and Data Provenance
- Positive Samples: 49 methadone-positive urine specimens
- Negative Samples: 60 methadone-negative urine specimens
- Data Provenance: The document states "clinical sample kit comparison study, using 49 methadone-positive urine specimens and 60 methadone-negative urine specimens." This indicates the data is from retrospective clinical specimens. There is no specific country of origin mentioned, but the manufacturer is based in San Diego, California, USA, implying the studies were likely conducted within the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established using laboratory methods rather than human expert interpretation of the device's results.
- Number of Experts: Not applicable in the traditional sense, as the ground truth was derived from analytical methods.
- Qualifications of Experts: Not specified, but the methods used (Behring EMIT II and GC/MS) are standard laboratory techniques that would be performed by qualified laboratory personnel.
4. Adjudication Method for the Test Set
The ground truth was established by comparison to two established laboratory methods: Behring EMIT II and GC/MS. While not an "adjudication" in the sense of multiple human readers, the use of two independent, highly regarded analytical methods served as the authoritative reference.
- Adjudication Method: Comparison to Behring EMIT II and Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is explicitly stated as "the preferred confirmatory method."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The study described is a performance evaluation of a rapid immunoassay device against established laboratory methods. There is no mention of human readers evaluating cases with and without AI assistance (as the device itself is a standalone immunoassay, not an AI assisting human interpretation).
6. Standalone Performance
Yes, a standalone performance study was done. The QuickScreen™ Methadone Screening Test is an "algorithm only" device in the sense that it provides a direct qualitative result (positive/negative) based on a chemical reaction, without human interpretation of complex images or data needing AI assistance. The performance reported directly reflects the device's ability to classify samples on its own.
7. Type of Ground Truth Used
- Type of Ground Truth: Analytical laboratory results from established methods. Specifically, Behring EMIT II (an immunoassay) and Gas Chromatography/Mass Spectrometry (GC/MS) (a highly specific and sensitive confirmatory method).
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or "validation set" in the context of machine learning. As a rapid immunoassay, the device's "training" refers to its design and calibration, not a machine learning model. The study described is a performance evaluation using clinical samples.
- Sample Size for Training Set: Not applicable or not specified in this type of device evaluation.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit training set described in the machine learning context, this question is not directly applicable. The device's design and internal calibration would rely on chemical principles and validation against known standards, which is a different process than establishing ground truth for a machine learning training set.
§ 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).