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SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations listed. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations listed. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided text describes the performance characteristics of the SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup. The document details analytical performance (precision, linearity, stability, interference, specificity, effect of specific gravity and pH) and comparison studies (method comparison and lay-user study).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each analytical performance characteristic are implicitly defined by the successful results reported in the study. The study aims to demonstrate that the device performs as expected according to its intended use and analytical specifications.

• Precision:

  • Acceptance Criteria for -100% to -25% Cut-off: All samples should test negative.
  • Acceptance Criteria for +25% to +100% Cut-off: All samples should test positive.
  • Acceptance Criteria for Cut-off (nominal concentration): Approximately 50% positive and 50% negative results (reflecting the nature of the cut-off).
  • Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
    • Dip Card (Lot 1, 2, 3):
      • -100% Cut-off to -25% Cut-off: 50-/0+ (All negative)
      • +25% Cut-off to +100% Cut-off: 50+/0- (All positive)
      • Cut-off: 24-/26+, 25-/25+, 26-/24+ (Split between positive and negative, as expected)
    • Cup (Lot 1, 2, 3):
      • -100% Cut-off to -25% Cut-off: 50-/0+ (All negative)
      • +25% Cut-off to +100% Cut-off: 50+/0- (All positive)
      • Cut-off: 27-/23+, 24-/26+, 26-/24+ (Split between positive and negative, as expected)

• Interference:

  • Acceptance Criteria: No interference from common physiological or pathological substances at specified concentrations.
  • Reported Device Performance: No interference observed for a comprehensive list of compounds at 100ug/mL (except albumin at 100mg/dL and ethanol at 1% volume).

• Specificity (Cross-Reactivity):

  • Acceptance Criteria: Related compounds should either not cross-react or cross-react at concentrations significantly higher than the cut-off, as defined by medical relevance.
  • Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
    • Methadone: Positive at 300000 ng/mL (0.1% cross-reactivity)
    • EMDP: Positive at 300000 ng/mL (0.1% cross-reactivity)
    • Doxylamine, Disopyramide, LAAM HCl, Alpha Methadol: Positive at >100,000 ng/mL (<0.3% cross-reactivity)

• Effect of Urine Specific Gravity and Urine pH:

  • Acceptance Criteria: Reliable results (positive above cut-off, negative below cut-off) across a specified range of specific gravity and pH.
  • Reported Device Performance: All samples at and above +25% Cut-Off were positive, and all samples at and below -25% Cut-Off were negative, for specific gravity from 1.000 to 1.035 and pH 4 to 9.

• Method Comparison Study (Clinical Samples):

  • Acceptance Criteria: High agreement (minimal discordant results) between the device results and LC/MS (Liquid Chromatography/Mass Spectrometry) results, especially for samples near the cut-off.
  • Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
    • Dip Card: High concordance with LC/MS, with few discordant results (e.g., Viewer A: 1 false positive at 291 ng/mL; Viewer B: 1 false negative at 309 ng/mL).
    • Cup: High concordance with LC/MS, with few discordant results (e.g., Viewer A: 1 false positive at 285 ng/mL; Viewer B: 1 false negative at 372 ng/mL).

• Lay-user Study:

  • Acceptance Criteria: High percentage of correct results for samples well below and well above the cut-off, and reasonable performance for samples near the cut-off, when interpreted by lay users. Ease of understanding instructions.
  • Reported Device Performance (for specific drugs like Amphetamine (AMP), Cocaine (COC), THC, BAR, BZO, MET, MTD, MDMA, OXY, OPI, BUP, PCP, TCA, PPX, EDDP as examples):
    • For samples at -100% to -50% Cut-off and +50% to +75% Cut-off: 100% correct results across all drugs.
    • For samples at -25% Cut-off: generally 90-95% correct negative results (some false positives).
    • For samples at +25% Cut-off: generally 85-95% correct positive results (some false negatives).
    • All lay users indicated the device instructions were easy to follow (Flesch-Kincaid Grade Level 7).

2. Sample Sizes Used for the Test Set and the Data Provenance

• Precision Study: For each drug and concentration, two runs per day for 25 days per device (Dip Card and Cup), implying a total of 50 tests per concentration per lot. With 3 lots, this is 150 tests per concentration per format. There were 9 concentrations tested. So 150*9 = 1350 tests per drug per format.
• Interference Study: Not explicitly stated, but tests were performed on "three batches of each device" for various interfering substances spiked into drug-free and drug-spiked urine samples.
• Specificity Study: Not explicitly stated how many tests per compound, but "three batches of each device" were used.
• Effect of Urine Specific Gravity and Urine pH Study: "three lots of each device" were used for samples spiked with target drugs at +/- 25% Cut-Off levels across the range of specific gravity and pH.
• Method Comparison Study: 80 "unaltered clinical samples" for each drug (40 negative and 40 positive relative to cut-off). This was conducted "in-house." The provenance of the clinical samples is not specified beyond being "clinical samples."
• Lay-user Study: 310 lay persons for each device format. The samples were prepared by spiking drugs into "drug free-pooled urine specimens." The concentrations were confirmed by LC/MS. Thus, the samples were prepared and not naturally occurring clinical samples.

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

• For the Precision, Interference, Specificity, and Effect of Urine Specific Gravity and Urine pH Studies: The ground truth was established by precise laboratory preparation of samples where drug concentrations were known and confirmed by LC/MS. There were no human experts classifying these samples for ground truth.
• For the Method Comparison Study: The ground truth was established by LC/MS results. LC/MS is a highly accurate and definitive analytical method. The text does not mention human experts establishing ground truth for these samples; it was based on the objective chemical analysis. The "three laboratory assistants" were operators performing the device tests, not establishing ground truth.
• For the Lay-user Study: The ground truth was the known drug concentration of the prepared urine samples, confirmed by LC/MS.

4. Adjudication Method for the Test Set

• Precision, Interference, Specificity, and Effect of Urine Specific Gravity and Urine pH Studies: No human adjudication was mentioned as the ground truth was based on precisely prepared samples with known concentrations.
• Method Comparison Study: The device results were compared directly to LC/MS results. There was no adjudication mentioned involving human experts to reconcile discrepancies between device and LC/MS. Discrepancies were simply reported as "discordant results."
• Lay-user Study: Comparisons were made against the known LC/MS confirmed concentrations of the prepared samples. No human adjudication was mentioned.

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. This device is a rapid diagnostic test (lateral flow immunoassay) for drug detection, where the "reading" is a visual interpretation of lines by a user (or laboratory assistant in the method comparison study). It does not appear to involve AI or sophisticated image analysis where human readers would be "assisted" by AI. The "lay-user study" involved multiple readers (310 lay persons), but it was designed to assess the ease of use and accuracy of the device itself by untrained individuals, not to compare human performance with and without AI assistance.

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

• This device is a lateral flow immunoassay intended for visual interpretation. It does not have an "algorithm only" component in the sense of a software-based AI system. Its performance inherently involves a "human-in-the-loop" to view and interpret the test lines.

7. The Type of Ground Truth Used

• The primary ground truth used throughout the studies (precision, interference, specificity, method comparison, and lay-user study) was LC/MS (Liquid Chromatography/Mass Spectrometry), which is a definitive analytical method for confirming drug concentrations in urine samples. For analytical studies, ground truth was also established by careful preparation of samples with known drug concentrations.

8. The Sample Size for the Training Set

• This document describes performance studies for an immunochromatographic assay, which is a chemical/biological test, not a machine learning or AI model. Therefore, there is no "training set" in the context of AI model development. The assays are "trained" during their manufacturing and chemical formulation processes to react at specific cut-off levels.

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

• As stated above, this device is not an AI/ML product and thus does not have a "training set" with ground truth in that context. The "training" of the assay refers to its inherent chemical design to react to certain drug concentrations, which relies on established analytical chemistry principles and known drug properties.

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