(78 days)
The ACON BAR One Step Barbiturates Test Strip and ACON BAR One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of barbiturates in urine at a cut-off concentration of 300 ng/mL. They are intended for use by healthcare professionals including professionals at point-of-care sites.
The ACON BAR One Step Barbiturates Test Strip and ACON BAR One Step Barbiturates Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of barbiturates in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of barbiturates in urine specimens at a designated cut-off concentration of 300 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 barbiturates at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Here's a breakdown of the acceptance criteria and study details for the ACON® BAR One Step Barbiturates Test Strip and Test Device, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance (ACON BAR One Step Barbiturates Test Strip) | Device Performance (ACON BAR One Step Barbiturates Test Device) |
|---|---|---|
| Comparison to Predicate Device (MCC Instant Screen Card BAR Test): | ||
| Positive Agreement: High agreement with predicate device | 100% (97% - 100%* CI) | 100% (97% - 100%* CI) |
| Negative Agreement: High agreement with predicate device | 99% (97% - 100%* CI) | 99% (97% - 100%* CI) |
| Overall Agreement: High agreement with predicate device | 99% (98% - 100%* CI) | 99% (98% - 100%* CI) |
| Comparison to GC/MS (at 300 ng/ml secobarbital cut-off): | ||
| Positive agreement with GC/MS: > 90% (implied for substantial equivalence) | 92% (86% - 96%* CI) | 92% (86% - 96%* CI) |
| Negative agreement with GC/MS: > 90% (implied for substantial equivalence) | 98% (94% - 99%* CI) | 98% (94% - 99%* CI) |
| Total agreement with GC/MS: > 90% (implied for substantial equivalence) | 95% (92% - 97%* CI) | 95% (92% - 97%* CI) |
| Clinical Performance: Safe and effective in qualitatively detecting barbiturates in urine specimens at a secobarbital cut-off concentration of 300 ng/mL | Demonstrated and determined to be substantially equivalent to predicate. | Demonstrated and determined to be substantially equivalent to predicate. |
| Suitability for Point-of-Care Use: Demonstrated suitability for healthcare professionals, including point-of-care settings. | Demonstrated through Point-of-Care (POL) study (details not provided beyond mention) | Demonstrated through Point-of-Care (POL) study (details not provided beyond mention) |
| *CI: 95% Confidence Intervals |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 292 clinical urine specimens.
- Composition: Included 10% of samples with barbiturate concentrations at -25% to +25% of the cut-off range (300 ng/mL secobarbital).
- Data Provenance: Not explicitly stated, but it's a "clinical evaluation" using "clinical urine specimens," implying real-world human samples. No country of origin is specified, nor is it explicitly stated as retrospective or prospective; however, given it's a clinical evaluation for regulatory submission, it would typically be a prospective collection or a specifically curated retrospective collection for the validation study.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document refers to Gas Chromatography/Mass Spectrometry (GC/MS) analysis as the ground truth. GC/MS is an analytical chemistry technique, not a human expert. Therefore, the concept of "number of experts" and "qualifications of experts" does not directly apply in the same way it would for image interpretation or diagnosis. The "experts" would be the laboratory personnel performing and interpreting the GC/MS results, who are presumed to be qualified in analytical chemistry methods.
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Adjudication Method for the Test Set:
- Not applicable as the ground truth is established by a definitive analytical method (GC/MS), not by human interpretation requiring adjudication. Agreement was measured by comparing the device's qualitative results to the quantitative GC/MS results against the 300 ng/mL cut-off.
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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, an MRMC comparative effectiveness study was not done. This device is an immunoassay for chemical detection, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or complex data with and without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance reported for the ACON BAR One Step Barbiturates Test Strip and Test Device is standalone performance. It measures how the device itself performs against the predicate device and the GC/MS ground truth, without human-in-the-loop performance influencing the result-generating mechanism of the immunoassay itself. The "human-in-the-loop" would be the healthcare professional interpreting the visual line on the strip, but the performance metrics are for the device's ability to produce that correct visual indication.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis at the secobarbital cut-off concentration of 300 ng/ml. This is considered a highly accurate and definitive analytical method for drug detection.
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The sample size for the training set:
- The document describes a "clinical evaluation" and does not specify a separate "training set" in the context of machine learning algorithms. For in-vitro diagnostic devices like immunoassays, the development process involves internal verification and validation, but not a distinct "training set" in the AI sense. The 292 clinical urine specimens constitute the independent validation set against which the device's performance was formally assessed for regulatory submission.
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How the ground truth for the training set was established:
- As there is no explicitly defined "training set" in the AI sense, this question is not directly applicable. The device's underlying immunoassay principle is based on antigen-antibody binding, which is a chemical process, not a learned one. The "ground truth" for developing such a device would reside in the chemical properties of the antibodies and antigens and their interaction with known concentrations of the target analyte (barbiturates).
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).