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The Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.

The Healgen® Accurate Fentanyl Rapid Test Strip (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.

The Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.

The Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (CC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Healgen® Accurate Rapid Fentanyl Test Strip (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (C-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Healge® Accurate Rapid Fentanyl Test Cassette (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (C-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Healgen® Accurate Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each Healgen® Accurate Fentanyl Test consists of a Test Device in format of Cassette or Dip Card or Strip, and a package insert. Each Test Device is sealed with sachets of desiccant in an aluminum pouch.

The document provided is a 510(k) summary for a urine drug test for Fentanyl. It details the performance characteristics of the Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine), Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine), Healgen® Accurate Fentanyl Rapid Test Strip (Urine), Healgen® Accurate Rapid Fentanyl Test Strip (Urine), Healgen® Accurate Fentanyl Rapid Test Cassette (Urine), and Healgen® Accurate Rapid Fentanyl Test Cassette (Urine).

This document describes a medical device (rapid diagnostic test), not an AI/ML algorithm or software as a medical device (SaMD). Therefore, many of the requested criteria related to AI/ML studies (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set size/ground truth) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its performance.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, focusing on what is applicable to a rapid diagnostic test:

Acceptance Criteria and Reported Device Performance

For rapid diagnostic tests like this one, "acceptance criteria" are typically defined by performance characteristics such as precision (accuracy at and around the cutoff), specificity (no cross-reactivity with other substances), interference (no effect from common urine constituents), and comparison to a gold standard method. The document presents data to demonstrate these characteristics.

1. Table of Acceptance Criteria and the Reported Device Performance (Summary of Key Performance)

The document implicitly defines the acceptance criteria through the presented performance data, showing that the device consistently performs as expected at and around the cutoff concentration of 1.0 ng/mL for fentanyl.

• Expected 100% positive results for concentrations above cutoff.
• Mixed results expected at cutoff (ideally close to 50% positive/negative). | Cassette Example (across 3 lots, 60 tests per lot/concentration)
  -100% to -50% cut off: 60-/0+ (100% Negative)
  -25% cut off: 58-60 negative, 0-3 positive (e.g., Lot 2: 58-/2+, Lot 1: 60-/0+, Lot 3: 59-/1+)
  Cut off: Mixed results (e.g., Lot 1: 38+/22-, Lot 2: 33+/27-, Lot 3: 36+/24-)
  +25% to +100% cut off: 60+/0- (100% Positive)
  (Similar performance observed for Dip Card and Strip formats) |
  | Specificity (Cross-reactivity) | No significant interference from tested compounds at physiological/therapeutic concentrations, or clear cross-reactivity profiles are established. | Fentanyl Analogs/Metabolites:
• Cyclopropyl fentanyl: 1 ng/mL (100% cross-reactivity)
• Acetyl fentanyl: 1 ng/mL (100% cross-reactivity)
• Acrylfentanyl: 0.9 ng/mL (111.11% cross-reactivity)
• 4-Fluoro-isobutyrylfentanyl: 5 ng/mL (20% cross-reactivity)
• Norfentanyl: 30,000 ng/mL (0.003% cross-reactivity)
  (Extensive list of other non-fentanyl compounds tested at 100 µg/mL showed no cross-reactivity) |
  | Interference | No interference from common endogenous or exogenous substances in urine. | No interference from a wide range of compounds (e.g., acetaminophen, albumin, glucose, ethanol, common drugs) at specified concentrations. |
  | Effect of Urine Specific Gravity & pH | Performance should remain accurate across a range of urine specific gravity and pH values. | All samples (spiked at -50% and +50% Cut-Off levels) tested correctly across ranges of specific gravity (1.000 to 1.035) and pH (4 to 9). |
  | Method Comparison with LC/MS | High concordance with GC/MS (or LC/MS) as the gold standard, especially for samples far from the cutoff. Discrepancies primarily expected around the cutoff. | Cassette Example (80 clinical samples per operator):
• 7 Negative, 19 Low Negative: 100% agreement with LC/MS.
• Near Cutoff Negative (LC/MS 1.0 ng/mL): 20-21 Positive, 2-3 Negative (total 23 samples)
• 17 High Positive: 100% agreement with LC/MS.
  (Similar results for Dip Card and Strip formats. Discordant results are concentrated around the cutoff as expected for qualitative tests.) |
  | Lay-User Performance (For OTC products) | High percentage of correct results by untrained lay users following package insert instructions. | Cassette Example (140 lay persons total, 20 samples each concentration):
  -100% to -25% Cutoff: 100% correct negative results.
  +25% to +75% Cutoff: 100% correct positive results.
  (Exceptions for Dip Card: 1 false positive at -25% Cutoff, resulting in 95% correct. Strip: 100% correct across all positive/negative points.) |

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

• Precision Studies:

  • Sample Size: For each of the nine concentrations tested (from -100% cutoff to +100% cutoff), 60 tests were performed per device lot. With 3 lots, this implies 180 tests per concentration per device format (Cassette, Dip Card, Strip). Total for precision studies: 9 concentrations * 60 tests/concentration/lot * 3 lots * 3 formats = 4860 tests.
  • Data Provenance: Samples were prepared by spiking fentanyl into negative samples. Concentrations were confirmed by LC/MS. The document does not specify the country of origin, but generally, these types of lab studies for FDA submissions are conducted domestically or in compliant international facilities. These are prospective experiments.

• Specificity and Interference Studies:

  • Sample Size: "Three batches of each device" were used. The number of individual tests on each substance is not explicitly stated, but it's implied that sufficient replicates were performed to draw conclusions.
  • Data Provenance: Substances were added to drug-free urine and target drug fentanyl urine. These are prospective lab experiments.

• Method Comparison Studies (Clinical Samples):

  • Sample Size: 80 "unaltered clinical samples" were used for each device format (Cassette, Dip Card, Strip). These 80 samples were split into categories: 7 Negative (0 ng/mL), 19 Low Negative, 14 Near Cutoff Negative, 23 Near Cutoff Positive, and 17 High Positive. Each sample was tested by three different operators.
  • Data Provenance: "unaltered clinical samples." The document does not specify the country of origin, but implies real-world urine specimens. It is a retrospective evaluation against a confirmed gold standard.

• Lay-User Study:

  • Sample Size: 140 lay persons participated for each device format (Cassette, Dip Card, Strip). Each participant received 1 blind-labeled sample. The samples themselves were prepared with different fentanyl concentrations, with 20 samples per concentration level.
  • Data Provenance: Urine samples were prepared by spiking fentanyl into drug-free pooled urine specimens. Concentrations were confirmed by LC/MS. This is a prospective study involving human subjects (lay users).

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

• The ground truth for all performance studies (precision, specificity, interference, method comparison, lay-user study) was established by LC/MS (Liquid Chromatography-Mass Spectrometry) or GC/MS (Gas Chromatography-Mass Spectrometry). These are established analytical chemistry methods considered the "gold standard" for confirming drug concentrations in toxicology.
• While these methods require expert chemists/toxicologists to operate and interpret, the document does not specify the "number of experts" or their "qualifications" in the same way one would for clinical image interpretation, as the ground truth is obtained from an analytical instrument, not human interpretation of a test. The results from LC/MS are quantitative and definitive.

4. Adjudication Method for the Test Set

• For the analytical performance and method comparison studies, the rapid test results (positive/negative) were directly compared to the quantitative LC/MS results.
• For the method comparison study, the results of three different operators were compared for each sample. The tables present the agreement of each operator's reading with the LC/MS result. Discordant results are explicitly listed for each operator involved. There is no mention of an "adjudication method" in the sense of a committee for final decision-making, as the LC/MS result serves as the definitive reference.

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

• Not Applicable. This is a rapid diagnostic test (an in-vitro diagnostic device), not an AI/ML SaMD that assists human readers. No MRMC comparative effectiveness study was done for AI assistance, as AI is not part of this device.

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

• Not Applicable. This is a rapid diagnostic test, interpreted visually by a human (either a trained operator or a lay user). There is no "algorithm" component in this device in the sense of an AI/ML model for standalone performance evaluation. The "test" itself is the standalone device performance when read correctly by a human.

7. The Type of Ground Truth Used

• The primary ground truth used throughout the studies was LC/MS (Liquid Chromatography-Mass Spectrometry) or GC/MS (Gas Chromatography-Mass Spectrometry) results. These are highly accurate, quantitative analytical methods for identifying and quantifying substances in a sample.

8. The Sample Size for the Training Set

• Not Applicable. This device is a rapid immunoassay test, not an AI/ML algorithm that requires a "training set" in the computational learning sense. The device's "training" would be its manufacturing process and quality control.

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

• Not Applicable. As there is no AI/ML training set, this question is not relevant to this device.

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