(98 days)
The ACON® One Step Multi-Drug Multi-Line Screen Test Card and Test Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of two to six drugs in a variety of combinations in human urine. The designated cut-off concentrations for these drugs are as follows: Amphetamine at 1,000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1,000 ng/ml, Opiates at 2,000 ng/ml, Marijuana at 50 ng/ml and Phencyclidine at 25 ng/ml. They are intended for healthcare professionals including professionals at the point of care sites.
The ACON One Step Multi-Drug Multi-Line Screen Test Card and Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Amphetamine, Cocaine, Methamphetamine, Opiates, Marijuana, and Phencyclidine in urine samples. The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibodies to selectively detect elevated levels of Amphetamine, Methamphetamine, Cocaine, Opiates, THC and PCP in urine at the cut-off concentrations of 1,000 ng/ml (AMP), 1,000 ng/ml (mAMP), 300 ng/mL (COC), 2,000 ng/ml (OPI), 50 ng/ml (THC) and 25 ng/ml (PCP). These tests can be performed without the use of an instrument.
A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing of Amphetamine, Cocaine, Methamphetamine, Opiates, Marijuana, and Phencyclidine at the concentrations below the designated cut-off levels will generate a colored-line in the designated test region for the drug. 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 an analysis of the acceptance criteria and study details for the ACON One Step Multi-Drug Multi-Line Screen Test Card and Test Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ACON One Step Multi-Drug Multi-Line Screen Test Card and Test Device appear to be based on achieving high agreement rates (positive, negative, and overall) with both previously FDA-cleared single drug tests and Gas Chromatography/Mass Spectrometry (GC/MS) analysis. While specific numeric acceptance thresholds are not explicitly stated as "acceptance criteria," the consistently high percentage agreements demonstrated in the results (mostly 95% and above, often 99%) with narrow confidence intervals imply that such high agreement was the de facto criterion for acceptance.
Device Performance vs. Predicate Device (ACON Single Tests):
| Drug | Device | Acceptance Criteria (Implied: High Agreement) | Reported Performance (Positive Agreement) | Reported Performance (Negative Agreement) | Reported Performance (Overall Agreement) |
|---|---|---|---|---|---|
| AMP | Test Card | High Agreement (>95% for all) | 99% (97% - 99%) | >99% (98% - 99%) | >99% (98% - 99%) |
| COC | Test Card | High Agreement (>95% for all) | >99% (97% - 99%) | 99% (97% - 99%) | 99% (98% - 99%) |
| mAMP | Test Card | High Agreement (>95% for all) | 99% (96% - 99%) | >99% (98% - 99%) | 99% (98% - 99%) |
| OPI | Test Card | High Agreement (>95% for all) | 98% (95% - 99%) | >99% (98% - 99%) | >99% (97% - 99%) |
| THC | Test Card | High Agreement (>95% for all) | >99% (97% - 99%) | 99% (97% - 99%) | 99% (98% - 99%) |
| PCP | Test Card | High Agreement (>95% for all) | 99% (93% - 99%) | >99% (98% - 99%) | 99% (97% - 99%) |
| AMP | Test Device | High Agreement (>95% for all) | >99% (97% - 99%) | >99% (98% - 99%) | >99% (98% - 99%) |
| COC | Test Device | High Agreement (>95% for all) | >99% (97% - 99%) | >99% (97% - 99%) | >99% (98% - 99%) |
| mAMP | Test Device | High Agreement (>95% for all) | >99% (97% - 99%) | >99% (98% - 99%) | >99% (98% - 99%) |
| OPI | Test Device | High Agreement (>95% for all) | >99% (96% - 99%) | >99% (98% - 99%) | >99% (98% - 99%) |
| THC | Test Device | High Agreement (>95% for all) | >99% (97% - 99%) | >99% (98% - 99%) | >99% (98% - 99%) |
| PCP | Test Device | High Agreement (>95% for all) | 99% (95% - 99%) | >99% (98% - 99%) | 99% (97% - 99%) |
Device Performance vs. GC/MS Analysis:
| Drug | Device | Acceptance Criteria (Implied: High Agreement) | Reported Performance (Positive Agreement) | Reported Performance (Negative Agreement) | Reported Performance (Overall Agreement) |
|---|---|---|---|---|---|
| AMP | Test Card | High Agreement (>90% generally) | 95% (90% - 98%) | 99% (97% - 99%) | 97% (95% - 99%) |
| COC | Test Card | High Agreement (>90% generally) | 95% (89% - 98%) | 99% (97% - 99%) | 98% (95% - 99%) |
| mAMP | Test Card | High Agreement (>90% generally) | 90% (84% - 94%) | >99% (98% - 100%) | 96% (93% - 98%) |
| OPI | Test Card | High Agreement (>90% generally) | 99% (96% - 99%) | 99% (96% - 99%) | 99% (97% - 99%) |
| THC | Test Card | High Agreement (>90% generally) | 95% (90% - 98%) | 95% (91% - 98%) | 95% (92% - 97%) |
| PCP | Test Card | High Agreement (>90% generally) | 90% (81% - 95%) | 99% (96% - 99%) | 96% (93% - 98%) |
| AMP | Test Device | High Agreement (>90% generally) | 94% (89% - 97%) | 99% (97% - 99%) | 97% (94% - 99%) |
| COC | Test Device | High Agreement (>90% generally) | 95% (89% - 98%) | 99% (97% - 99%) | 98% (95% - 99%) |
| mAMP | Test Device | High Agreement (>90% generally) | 90% (83% - 94%) | >99% (98% - 100%) | 95% (92% - 97%) |
| OPI | Test Device | High Agreement (>90% generally) | 99% (96% - 100%) | 99% (96% - 99%) | 99% (97% - 99%) |
| THC | Test Device | High Agreement (>90% generally) | 95% (90% - 98%) | 96% (91% - 98%) | 95% (92% - 97%) |
| PCP | Test Device | High Agreement (>90% generally) | 90% (81% - 95%) | 99% (96% - 99%) | 96% (92% - 98%) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Over 1,000 clinical urine specimens were employed. Approximately 10% of these samples had drug concentrations in the -25% to +25% cut-off range.
- Data Provenance: The data is described as "clinical urine specimens," implying they were collected from real-world patients. The country of origin is not explicitly stated, but the submission is to the FDA (USA), suggesting the data is relevant to US clinical settings, though not necessarily collected in the US. The study is retrospective, as it uses existing clinical specimens to compare the new device against established methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish the ground truth.
- For the comparison with predicate devices, the "ground truth" seems to be the result from the previously FDA-cleared ACON single drug tests. These are also immunochromatographic tests.
- For the comparison with GC/MS analysis, the GC/MS result is considered the gold standard "ground truth." GC/MS analysis is a laboratory-based method. The qualifications of the personnel performing or interpreting the GC/MS results are not specified, although it is a recognized analytical standard in toxicology.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The comparison is direct: the new device's result is compared to the predicate device's result and to the GC/MS result. Discrepancies are noted in the agreement percentages, but a formal adjudication process for discordant results is not detailed.
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 Study: This is not an AI-assisted diagnostic device. It is a rapid diagnostic test (immunochromatographic assay) designed for qualitative, visual interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study as typically understood for AI in medical imaging, and the concept of human readers improving with AI assistance, is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical immunoassay device, not an algorithm. The interpretation of the test result (presence or absence of a colored line) is inherently human-in-the-loop, though it's a straightforward visual inspection, not a complex diagnostic image interpretation task. The "standalone" performance here refers to the device's ability to produce a result that aligns with the ground truth when interpreted as intended. The performance tables do represent the standalone performance of the device when read by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Two types of ground truth were used:
- Predicate Device Results: The results from previously FDA-cleared ACON single drug test strips.
- GC/MS Analysis (Gas Chromatography/Mass Spectrometry): This is a highly accurate and widely accepted laboratory analytical method for drug detection and quantification in toxicology, considered the "gold standard" for this application.
8. The Sample Size for the Training Set
- The document does not mention a training set. This is because the device is a chemical/immunological assay, not a machine learning or AI algorithm that requires training data. The development of such devices relies on chemical formulation, antibody specificity, and physical design, not data training in the AI sense.
9. How the Ground Truth for the Training Set was Established
- As there is no training set in the context of an AI/ML algorithm, this question is not applicable. The device's design and performance are established through laboratory R&D and then validated using clinical samples against established methods (predicate device and GC/MS) as described above.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).