(141 days)
The ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device are rapid chromatographic immunoassays for the qualitative detection of Oxycodone levels in urine at a designated cutoff concentration of 100 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.
The ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Oxycodone 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 Oxycodone and its metabolite in urine at a cutoff concentration of 100 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 Oxycodone at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a coloredline should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Here's an analysis of the acceptance criteria and study detailed in the provided text:
Acceptance Criteria and Device Performance
The core of the study is a comparison of the ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device against a predicate FDA-cleared Oxycodone test and GC/MS analysis. The acceptance criteria aren't explicitly stated as numerical targets in the provided text, but rather implied through "substantial equivalency" to a predicate device and satisfactory performance against GC/MS. Based on the presented data, the implied acceptance criteria would likely be high agreement rates (e.g., >95% for positive and negative agreement).
| Acceptance Criteria (Implied) | ACON® OXY One Step Oxycodone Test Strip Performance (vs. FDA-cleared test) | ACON® OXY One Step Oxycodone Test Device Performance (vs. FDA-cleared test) | ACON® OXY One Step Oxycodone Test Strip Performance (vs. GC/MS) | ACON® OXY One Step Oxycodone Test Device Performance (vs. GC/MS) |
|---|---|---|---|---|
| High Positive Agreement | 97% (93% - 99% CI) | 97% (93% - 99% CI) | 96% (92% - 98% CI) (for positive samples by test) | 96% (92% - 98% CI) (for positive samples by test) |
| High Negative Agreement | 100% (98% - 100% CI) | 100% (98% - 100% CI) | 98% (95% - 99% CI) (for negative samples by test) | 98% (95% - 99% CI) (for negative samples by test) |
| High Overall Agreement | 99% (97% - 99% CI) | 99% (97% - 99% CI) | Not explicitly calculated, but implied by individual agreements. | Not explicitly calculated, but implied by individual agreements. |
Study Details
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Sample Size used for the test set and the data provenance:
- Sample Size: 300 clinical urine specimens.
- Data Provenance: Clinical urine specimens are mentioned, implying human samples. The document does not specify the country of origin, nor whether the samples were retrospective or prospective, but clinical evaluation often implies prospective collection or representative retrospective collection for a device submission.
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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 for comparison was established primarily by Gas Chromatography/Mass Spectrometry (GC/MS) analysis and a FDA-cleared Oxycodone test. The document does not mention the use of human experts to establish the ground truth in the traditional sense, as these are lab-based analytical methods.
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Adjudication method for the test set:
- No adjudication method is described. The comparison is directly between the investigational devices and reference methods (FDA-cleared device and GC/MS).
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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 MRMC or comparative effectiveness study involving human readers and AI assistance was conducted or described. This device is a rapid chromatographic immunoassay, not an AI-based diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance evaluation was done. The ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone Test Device are intended to provide a preliminary analytical result without human interpretation beyond reading the visual line. Their performance was directly compared against a predicate device and GC/MS.
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The type of ground truth used:
- The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered a gold standard for confirming the presence and concentration of substances in urine. Additionally, an existing FDA-cleared Oxycodone test served as a reference for comparison.
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The sample size for the training set:
- The document does not specify a separate "training set" since this is a chemical immunoassay device, not typically an AI/machine learning model that undergoes a distinct training phase with a labeled dataset. The analytical studies (sensitivity, specificity, interference, precision, etc.) and clinical evaluation serve to validate the device's performance characteristics.
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How the ground truth for the training set was established:
- As there's no explicit training set in the context of an AI/ML model, this question is not directly applicable. For the device itself, the chemical and biological principles governing its function are based on established scientific knowledge and empirical validation through "Performance Characteristics and Other information" studies described (analytical sensitivity, specificity, cross-reactivity, interference, precision, read time flex, temperature flex, specimen storage and stability). These studies use controlled samples with known compositions to characterize the device's fundamental behavior.
§ 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).