(58 days)
The ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a designated cutoff concentration of 10 ng/mL. They are intended for use by healthcare professionals including professionals at point-of-care sites to assist in the determination of drug compliance.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result atchuid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory mcthods.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Buprenorphine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Buprenorphine in urine at a cutoff concentration of 10 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Buprenorphine at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The provided text describes the ACON BUP One Step Buprenorphine Test Strip and Device, which are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific percentages for positive, negative, or overall agreement. Instead, it presents the device's performance results against two comparators: a FDA-cleared Buprenorphine test and LC/MS analysis. The "acceptance" is implied by the FDA's substantial equivalence determination, meaning the performance was deemed acceptable relative to a legally marketed predicate.
However, we can infer performance targets for the purpose of demonstrating substantial equivalence. The reported performance is as follows:
| Performance Metric | Acceptance Criteria (Implied by equivalence) | ACON BUP One Step Test Strip Reported Performance (95% CI) | ACON BUP One Step Test Device Reported Performance (95% CI) |
|---|---|---|---|
| Vs. FDA-cleared BUP Test | |||
| Positive Agreement | High agreement | 84% (73% - 92%) | 84% (73% - 92%) |
| Negative Agreement | Very high agreement | 99% (97% - 99%) | 99% (97% - 99%) |
| Overall Agreement | High agreement | 95% (91% - 98%) | 95% (91% - 98%) |
| Vs. LC/MS (Cutoff: 10 ng/mL) | |||
| Positive Agreement | High agreement (for positive specimens) | 98% (90%-99%) (55/56) | 98% (90%-99%) (55/56) |
| Negative Agreement | Very high agreement (for negative specimens) | >99% (98%-100%) (170/170) | >99% (98%-100%) (170/170) |
| Total Agreement | Very high agreement | 99.6% (98% - 99%) | 99.6% (98% - 99%) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for the Test Set: 226 clinical urine specimens.
- Data Provenance: The document does not specify the country of origin. The study used "clinical urine specimens," implying they were collected from real-world patients, but it doesn't state if they were collected retrospectively or prospectively. Given the context of a 510(k) submission and the term "clinical evaluation," it's likely a retrospective collection of samples with known Buprenorphine concentrations or confirmed by an existing method.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth for the test set. The ground truth was established by:
- Comparison with an FDA-cleared Buprenorphine test.
- Comparison with Liquid Chromatography/Mass Spectrometry (LC/MS) analysis, which is considered the "gold standard" for drug confirmation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method involving human readers is described for the test set. The comparisons are entirely based on the results from the devices, the predicate device, and LC/MS.
5. 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 MRMC comparative effectiveness study was done. This device is a standalone immunoassay kit, not an AI-powered diagnostic system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted. The ACON BUP One Step Buprenorphine Test Strip and Test Device are intended to be used as standalone tests, providing a qualitative result. The "Safety and Effectiveness Data" section details the performance of these devices in comparison to existing methods without any human-in-the-loop assistance for interpretation beyond reading the visual result of the strip/device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance evaluation was established using:
- Comparison against an FDA-cleared predicate Buprenorphine test.
- Liquid Chromatography/Mass Spectrometry (LC/MS) analysis, which is a highly specific and sensitive analytical method considered definitive for drug identification and quantification.
8. The sample size for the training set
The document does not mention a "training set" in the context of machine learning or AI. This device is an immunoassay, not an algorithm that requires training data. The development and validation of the immunoassay itself would have involved laboratory testing and optimization, but not a "training set" in the computational sense.
9. How the ground truth for the training set was established
As there is no mention of a training set for an algorithm, this question is not applicable to the described device.
§ 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).