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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 Cutoff concentrations for these drugs are as follows: Barbiturates at 300 ng/mL, Benzodiazepines at 300 ng/mL, Methadone at 300 ng/mL, Methylenedioxymethamphetamine (Ecstasy) at 500 ng/mL, Opiates at 300 ng/mL and Tricyclic antidepressant at 1,000 ng/mL. They are intended for healthcare professionals including professionals at 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 Barbiturates, Benzodiazepines, Methadone, MDMA, Opiates and Tricyclic Antidepressants in urine samples. The test is based on the principle of antigenantibody immunochemistry. It utilizes mouse antibodies to selectively detect elevated levels of Barbiturates, Benzodiazepines, Methadone, MDMA, Opiates and Tricyclic Antidepressants in urine at Cutoff concentrations of 300 ng/mL (BZO), 1,000 ng/mL (TCA), 300 ng/mL (BAR), 500 ng/mL (MDMA), 300 ng/mL (MTD) and 300 ng/mL (MOP). 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 Barbiturates, Benzodiazepines, Methadone, MDMA, Opiates and Tricyclic Antidepressants at the concentrations below the designated cutoff 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 a summary of the acceptance criteria and the study that proves the ACON One Step Multi-Drug Multi-Line Screen Test meets them, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the ACON One Step Multi-Drug Multi-Line Screen Test were implicitly established by comparing its performance against GC/MS analysis, which is considered the gold standard for drug detection in urine. The predicate devices, previously FDA-cleared single drug tests, also served as a benchmark for substantial equivalence. The reported device performance is presented in the tables below for both the "Test Card" and "Test Device" variants.

ACON Test Card Performance vs. GC/MS Analysis (95% Confidence Interval)

ACON Test Device Performance vs. GC/MS Analysis (95% Confidence Interval)

The study aimed to demonstrate "substantial equivalency" to previously FDA-cleared tests and that the device is "safe and effective" in detecting the specified drugs at the given cutoff concentrations. The high percentages for positive, negative, and overall agreement across all drugs and both device forms indicate the device met these implicit acceptance criteria effectively.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: "Over 1,000 clinical specimens" were employed for the clinical evaluation. Approximately 10% of these samples had drug concentrations in the -25% to +25% Cutoff range. The exact breakdown per drug is available in the tables above, ranging from 226 to 306 total specimens per drug.
   • Data Provenance: The text states "clinical urine specimens" were used, without specifying the country of origin. The study appears to be retrospective, as it involved collected "clinical urine specimens" and comparison with "previously FDA-cleared Barbiturates, Benzodiazepines, Methadone, MDMA, Opiates and Tricyclic Antidepressants Single tests; as well as against data obtained from the customary GC/MS analysis."

2. 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 GC/MS analysis. This is a laboratory technique and does not involve human experts in the traditional sense of interpreting results. The personnel operating the GC/MS equipment would be trained laboratory technicians, but their qualifications are not specified nor are they referred to as "experts" for ground truth establishment in this context.

3. Adjudication method for the test set:

   • No adjudication method (e.g., 2+1, 3+1) is described for the test set. The direct comparison was made between the ACON device results and the GC/MS analysis results.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This study compared the device's performance against a gold standard (GC/MS) and predicate devices, not primarily the improvement of human readers with or without AI assistance, as AI is not the primary technology here.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance evaluation was conducted. The ACON One Step Multi-Drug Multi-Line Screen Test Card and Test Device are rapid chromatographic immunoassays that provide a visual, qualitative end result. The performance data presented in the tables are the results of the device alone in detecting the presence of drugs compared to GC/MS. The "physician's office laboratory POL study" mentioned at the end suggests use by "professionals at point-of-care sites," implying human interpretation of the visual result, but the core accuracy data are derived from the device's ability to correlate with GC/MS.

6. The type of ground truth used:

   • The ground truth used was GC/MS analysis, which is a highly accurate and widely accepted laboratory method for confirming the presence and concentration of drugs in biological samples.

7. The sample size for the training set:

   • The document does not specify a separate training set or its size. This is typical for in vitro diagnostic (IVD) devices that are not based on machine learning or AI algorithms requiring explicit training data. The device's design (antigen-antibody immunochemistry) is based on established scientific principles rather than learning from data.

8. How the ground truth for the training set was established:

   • As no training set is described for this type of immunoassay device, the establishment of ground truth for a training set is not applicable.

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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):

Device Performance vs. GC/MS Analysis:

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:

1. Predicate Device Results: The results from previously FDA-cleared ACON single drug test strips.
2. 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.

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