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The ACCU NEW® Drug Screening Test Card Urine Cup are immunochromatographic assays for the qualitative determination of the drugs/drug metabolites in human urine. The test cutoff concentrations and the tests are calibrated to are as follows:

The ACCU NEWS® Drug Screening Test Card /Urine Cup can consist of any combination of the drug analytes listed above.

For in vitro diagnostic use only. The tests are intended for both prescription and over-the-counter (OTC) use.

The device provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectronetry (LCMS) are the preferred confirmatory methods. Clinical consideration and professional judgement should be exercised for any drugs of abuse test results, particularly when preliminary results are positive.

ACCU NEWS® Drug Screening Test Card/Urine Cup is based on the principle of highly specific immunochemical reactions between antigens and antibodies. The devices utilize a competitive immunoassay in which a drug-protein conjugate immobilized on a nitrocellulose membrane competes with the drug target present in human urine for limited binding sites presented in colloidal gold-labeled mouse monoclonal antibody. The presence of a color band at a test region (coated with drug-protein conjugate) indicates a negative result for that particular test. The absence of a color band at the test region indicates presumptive positive result for that particular test.

A color band at the control region, which was coasted with goat anti-mouse polyclonal antibody, should always appear regardless of the presence of the drug or its metabolites. The presence of the control band during testing serves as a built-in procedural control, indicating the completion of the test and validity of the operation.

There are two formats of the test device, and both of them operate on the same basic principle. ACCU NEWS® Drug Screening Test Card device consists of individual test strips encased in a protective plastic case, and the device can detect up to 5 drugs/drug metabolites simultaneously. The ACCU NEWS® Drugs of Abuse Screening Urine Cup consists of the assembled test card integrated into a sample collection cup. Both formats are single-use, in vitro diagnostic devices.

Test results interpretation:

Negative: Two pink lines appear, one in the control region and the other in the test region. Regardless of the color intensity, any line formed in the test region, even if it is faint, the result is considered negative.

Positive: Only one pink line appears in the control region, and no line appears in the test region.

Invalid: If no line appears in the control region, the test result is invalid regardless of the absence or presence of the test line.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for ACCU NEWS® Drug Screening Test Card/Urine Cup

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally inferred from the "Agreement with GC/MS" percentages reported in the performance studies. Since the device is a qualitative screen, the primary measures of performance are accuracy (agreement with the gold standard) across various concentrations, especially near and beyond the cutoff. The lay-user study also demonstrates usability by untrained individuals.

Device Performance for Test Card (Overall % Agreement with GC/MS):

• AMP (Amphetamine): 98.0%
• MET (Methamphetamine): 97.0%
• MOP (Morphine): 98.0%
• COC (Cocaine): 97.0%
• THC (Marijuana): 98.0%

Device Performance for Urine Cup (Overall % Agreement with GC/MS):

• AMP (Amphetamine): 98.0%
• MET (Methamphetamine): 97.0%
• MOP (Morphine): 98.0%
• COC (Cocaine): 98.0%
• THC (Marijuana): 98.0%

Lay-User Study Performance (Agreement with GC/MS):

• AMP, MET, MOP, COC (Test Card & Urine Cup): 100%
• THC (Test Card & Urine Cup): 99.7%

2. Sample Sizes and Data Provenance

• Precision/Sensitivity Study:
  • Test Set Sample Size: For each drug (AMP, MET, MOP, COC, THC), for both Test Card and Urine Cup formats, there were 6 urine samples spiked at different concentrations (negative, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff). These samples were tested by 3 operators, using 3 lots of devices, over 6 days. This would mean 3 (operators) * 3 (lots) * 6 (days) = 54 tests per concentration. So, for each drug, there were 54 * 6 = 324 tests. The tables show 30 results for each concentration, which implies the results are aggregated per concentration (e.g., 30-/0+ means 30 negative results out of 30 tests performed at that concentration).
  • Data Provenance: Not explicitly stated, but clinical urine samples were used in the Method Comparison study, implying they are real-world samples. The spiking of drug-free urine suggests lab-prepared samples for the precision study.
• Method Comparison Study:
  • Test Set Sample Size: A total of 340 clinical urine samples were collected. The tables suggest that for each drug, there were approximately 40 samples from each category (No Drug Present, Near Cutoff Negative, Near Cutoff Positive, High Positive), though the exact breakdown varies slightly by drug (e.g., 40, 10, 2, 0 for THC negative samples). This means each drug had around 100-110 samples tested. Given five drugs, this aligns with the total of 340 samples.
  • Data Provenance: "340 clinical urine samples were collected." This indicates prospective or retrospective clinical data, although the country of origin is not specified.
• OTC Lay-User Study:
  • Test Set Sample Size: 300 lay persons participated. The tables for each drug and concentration show results for 20 samples at each spiked concentration (-50%, -25%, +25%, +50%, +100% cutoff) and 180 negative samples. This implies that each lay-user tested multiple samples or the 300 lay users each tested a subset of these samples, adding up to the total counts (e.g., 180 tests for negative samples).
  • Data Provenance: The study was conducted at 3 sites, but the country of origin is not specified. These were lab-prepared samples spiked with drugs.

3. Number of Experts and Qualifications for Ground Truth

• Precision/Sensitivity, Method Comparison, and Lay-User Studies: The ground truth for all studies was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis or Liquid Chromatography/Mass Spectrometry (LC-MS). These are highly accurate, laboratory-based analytical techniques considered the gold standard for drug confirmation testing.
• Number of Experts/Qualifications: The document does not specify the number or qualifications of the individuals who performed the GC/MS/LC-MS analyses. However, GC/MS and LC-MS are instrumental methods performed by trained laboratory personnel.

4. Adjudication Method for the Test Set

• None explicitly mentioned. The ground truth was established by GC/MS or LC-MS. The device results were compared directly to these objective analytical methods. For the lay-user study, the lay-users provided their interpretations, which were then compared to the GC/MS results. The document does not describe any expert adjudication process for discordant results beyond the initial GC/MS/LC-MS confirmation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done in the traditional sense. The study involves human readers (operators and lay-users) interpreting the device, and the device's performance (including misinterpretations by users) is compared to the GC/MS ground truth.
• Effect Size: While not a typical MRMC study comparing AI vs. human, the "Lay-User Study" inherently evaluates the device's performance when interpreted by untrained human readers. The agreement rates of 99.7% to 100% with GC/MS (including potential user error) demonstrate that the device is effectively used by human readers for its intended purpose. The document specifically states: "This demonstrated that the devices were easy enough to be used by untrained lay-users."

6. Standalone Performance Study (Algorithm only without human-in-the-loop)

• Yes, in essence. The "Precision/Sensitivity" and "Method Comparison" sections can be considered standalone performance evaluations of the device itself, as the 'operators' are simply reading the instrument (test device) and comparing it to the gold standard. While human visual inspection is involved in reading the lines, the performance metrics reported (e.g., % Agreement with GC/MS) reflect the device's ability to accurately detect drugs at various concentrations, regardless of the user variability captured in the lay-user study. The "Interference" and "Specificity" studies also demonstrate the device's intrinsic characteristics.

7. Type of Ground Truth Used

• Gold Standard Laboratory Analytical Methods:
  • Gas Chromatography/Mass Spectrometry (GC/MS)
  • Liquid Chromatography/Mass Spectrometry (LC-MS)
  • These are considered definitive confirmatory methods for drug analysis.

8. Sample Size for the Training Set

• Not explicitly mentioned. As this is an in-vitro diagnostic (IVD) device (a lateral flow immunoassay), it is not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense. The device's "training" or development would involve optimizing the chemical reagents, antibody concentrations, and manufacturing parameters, which is part of the engineering and development process, not typically described as a "training set" in the context of device validation.

9. How the Ground Truth for the Training Set was Established

• Not applicable, as this is not an AI/ML device with a training set. The development of the device would rely on chemical and immunological principles, with performance verified against known concentrations of analytes, likely using GC/MS or similar methods during the R&D phase to ensure the device's components react as intended.

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The ACCU NEWS One Step Pregnancy Test Strip: The ACCU NEWS One Step Pregnancy Test Strip is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.

ACCU NEWS One Step Pregnancy Test Cassette: The ACCU NEWS One Step Pregnancy Test Cassette is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.

ACCU NEWS One Step Pregnancy The ACCU NEWS One Step Pregnancy Test Midstream is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.

ACCU NEWS "M One Step hCG Pregnancy Test is a qualitative lateral flow test for the detection of hCG (human chorionic gonadotropin) hormone, which is present in urine during the early stage of pregnancy. It is built on a basic lateral flow immunoassay test strip model containing 6 components as illustrated below:

The nitrocellulose membrane is coated with Goat anti-mouse IgG polyclonal antibody on the control line and anti-alpha hCG mouse monoclonal antibody on the test line. The conjugate pad contains colloidal-gold-labeled anti-beta mouse monoclonal hCG antibody. When urine specimen is drawn through the sample pad, the hCG present in the urine will react with the anti-beta monoclonal hCG antibody on the conjugate pad and the antialpha monoclonal hCG antibody on the test line to develop visible lines in the test region.

The ACCU NEWS TM One Step hCG Pregnancy Test is available in three different formats: 1) strip, 2) cassette, and 3) midstream.

The provided text describes the acceptance criteria and a study demonstrating the performance of the ACCU NEWS™ One Step hCG Pregnancy Test.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Precision/Sensitivity Study:

  • Test Set Sample Size: For each of the three formats (Strip, Cassette, Midstream), and for each of 6 hCG concentrations (0, 12.5, 18.75, 25, 50, 100 mIU/mL), at least 30 urine samples were tested. This means a minimum of 3 (formats) * 6 (concentrations) * 30 (samples) = 540 samples were used in total across the three lots for each format.
  • Data Provenance: Urine samples were used. The study was carried out at three sites (one internal site and two external sites), implying a mix of internal and potentially external, real-world data points. The text doesn't specify the country of origin of the data, but the company is based in Carlsbad, CA, USA. The study appears to be prospective in nature, as specific experiments were designed and performed to evaluate the device.

• Comparison Study:

  • Test Set Sample Size: 250 female donors. Urine samples were collected from these donors.
  • Data Provenance: Urine samples were randomly collected from 250 female donors from three sites at various times throughout the day. The text doesn't specify the country of origin. This appears to be a prospective study.

• OTC Lay-User Test Result:

  • Test Set Sample Size: 250 female donors.
  • Data Provenance: Urine samples were randomly collected from 250 female donors at three sites. This appears to be a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Precision/Sensitivity Study: The "ground truth" for the hCG concentrations (0, 12.5, 18.75, 25, 50, 100 mIU/mL) was established by external calibration against the hCG standard WHO 3rd IS. This implies laboratory standards rather than clinical expert consensus for ground truth on concentration. The results were then read by individuals at the testing sites, but their specific qualifications as "experts" for establishing ground truth are not detailed beyond "each site tested a unique lot of test device."

• Comparison Study & OTC Lay-User Test Result:

  • For the comparison study and the OTC lay-user study, the "ground truth" for the pregnancy status of the 250 urine samples was primarily established by the predicate hCG test. Healthcare professionals also tested the urine samples with the ACCU NEWS™ devices, and their results served as a professional ground truth for the lay-user comparison. The qualifications of these "healthcare professionals" are not specified (e.g., radiologist, lab technician, nurse), nor is the exact number of such professionals.

4. Adjudication Method for the Test Set:

• No explicit adjudication method (like 2+1 or 3+1) is described for resolving discrepancies in any of the studies.
• In the Precision/Sensitivity study, the results are presented as counts for '+' and '-' readings for each lot and concentration, and there's no mention of adjudication if readings differed.
• In the Comparison Study and OTC Lay-User Test Result studies, 100% agreement was observed between the subject device and the predicate device/healthcare professional readings, so no adjudication would have been needed to reconcile conflicting results.

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 using AI. This device is a lateral flow immunoassay (a rapid diagnostic test), not an AI-powered diagnostic tool requiring human interpretation with or without AI assistance. The "readers" are either the device itself (for objective lines) or human users interpreting the lines.

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

• This device is not an algorithm. It is a physical diagnostic test (lateral flow immunoassay). The "standalone" performance is essentially what is measured in the Precision/Sensitivity study, where the device's ability to detect various hCG concentrations is assessed directly.

7. The Type of Ground Truth Used:

• Precision/Sensitivity Study: The ground truth was known hCG concentrations in urine samples, calibrated against the WHO 3rd International Standard. This can be considered a form of a reference standard or analytical ground truth.
• Comparison Study: The ground truth was the results from a legally marketed predicate hCG test device. This is a comparative ground truth established against an existing, approved method.
• OTC Lay-User Test Result: The ground truth for lay-user performance was the results obtained by healthcare professionals using the ACCU NEWS™ device. This is a form of expert consensus/reference reading as ground truth for evaluating ease of use and interpretation by non-professionals.

8. The Sample Size for the Training Set:

• The document does not describe a "training set" in the context of machine learning or AI models. This device is a chemical immunoassay, not an AI-driven system. The development of the device would have involved internal R&D and optimization, but not formal "training sets" 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 model for this device, this question is not applicable. The development of the device's components and design would have been based on established clinical chemistry principles and validated through iterative testing and quality control processes.

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