(147 days)
The proposed BUP/NBUP Urine Test is a qualitative immunoassay for the rapid detection of buprenorphine and norbuprenorphine from human urine specimens. The test provides only a preliminary result. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with Rabbit anti-buprenorphine antibodies and mouse IgG, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with Buprenorphine-BSA, and the C line is coated with goat anti-mouse IgG antibodies.
Here's a breakdown of the acceptance criteria and study information for the INSTANT-VIEW® BUP/NBUP Urine Test, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity | 96.3% |
| Specificity | 97.3% |
| Accuracy | 96.8% overall agreement with GC/MS or HPLC/MS |
| Reproducibility | 97.1% for BUP (across 3 sites) |
| 98.4% for NBUP (across 3 sites) | |
| Stability | Predicted 2 years (24 months) shelf life (based on accelerated degradation) |
| Urine Specific Gravity Influence | No influence found for specific gravity ranging from 1.002 to 1.035 |
| Urine pH Influence | No influence found for pH ranging from 3.0 to 9.0 |
| Formats Equivalence | Cassette and dip-strip formats demonstrated to be equivalent |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Size: 94 clinical specimens.
- 54 specimens were confirmed BUP/NBUP clinical samples.
- 40 specimens were drug-free clinical samples.
- Data Provenance: The document does not explicitly state the country of origin. It refers to "clinical specimens," suggesting real-world samples. It does not specify if the data was retrospective or prospective, but the use of "clinical specimens" often implies a retrospective collection for such validation.
- Test Set Size: 94 clinical specimens.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth was established by HPLC/MS or GC/MS (High-Performance Liquid Chromatography/Mass Spectrometry or Gas Chromatography/Mass Spectrometry), which are analytical gold standard methods, not human experts. Therefore, the concept of "experts" in the traditional sense for establishing ground truth does not directly apply here. These methods are considered highly accurate and serve as the definitive reference.
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Adjudication method for the test set:
- Not applicable as the ground truth was established by analytical methods (HPLC/MS or GC/MS), not human interpretation requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This device is a qualitative immunoassay for chemical detection, not an AI-assisted diagnostic imaging or interpretation tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The device itself performs the detection (algorithm/chemical reaction only), producing a "preliminary positive" or negative result without direct human-in-the-loop performance influencing the result generating mechanism. The "human-in-the-loop" aspect comes in the interpretation of the preliminary result and the need for confirmatory testing.
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The type of ground truth used:
- Analytical Gold Standard / Confirmatory Chemical Method: HPLC/MS or GC/MS confirmed results.
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The sample size for the training set:
- The document does not explicitly mention a "training set" for the primary performance metrics (sensitivity, specificity, accuracy). Immunoassays typically rely on biochemical reactions rather than machine learning models that require distinct training and test sets in the same way. The 94 clinical specimens are referred to as the "studied" or "test" set for performance evaluation.
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How the ground truth for the training set was established:
- As no explicit "training set" is described in the context of machine learning, this question isn't directly applicable. For the samples used in the performance evaluation, the ground truth was established by HPLC/MS or GC/MS.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).