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Healgen Propoxyphene Test is an immunochromatographic assay for the qualitative determination of Propoxyphene in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when the prescription drug Propoxyphene is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Propoxyphene in urine. 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 is the prefered confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Healgen Nortriptyline Test is an immunochromatographic assay for the qualitative determination of Nortriptyline in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when the prescription is ingested, at prescribed doses, it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Nortriptyline in urine. 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 is the prefered confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Healgen EDDP (Methadone Metabolite) Test is an immunochromatographic assay for the qualitative determination of EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Healgen Propoxyphene Test, Healgen Nortriptyline Test and Healgen EDDP (Methadone Metabolite) Test are immunochromatographic assays for Propoxyphene, Nortriptyline and EDDP. Each assay test is a lateral flow system for the qualitative detection of Propoxyphene, Nortriptyline and EDDP (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the performance characteristics of the Healgen Propoxyphene Test, Healgen Nortriptyline Test, and Healgen EDDP (Methadone Metabolite) Test, which are immunochromatographic assays for the qualitative determination of these substances in human urine. The acceptance criteria and the studies performed to demonstrate the device meets these criteria are detailed.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, quantified threshold for each performance characteristic. Instead, it presents the results of various analytical and comparison studies, implying that the observed performance meets the manufacturer's internal standards for claiming substantial equivalence to a predicate device. For the purpose of this response, I will interpret the reported performance in the precision and cut-off studies as the de facto acceptance criteria demonstrated by the manufacturer.

The key acceptance criterion for qualitative drug tests is typically the ability to correctly classify samples as positive or negative relative to a defined cut-off concentration. For samples precisely at or near the cut-off, some variability is expected.

Implicit Acceptance Criteria and Reported Performance (Based on "Precision" and "Cut-off" Studies):

Detailed Study Information:

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

• Precision Test Set:

  • For each drug (Propoxyphene, Nortriptyline, EDDP) and each of the four formats (Strip, Cassette, Cup, Dip Card):
    • 9 different concentrations were tested (-100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100% of cut-off).
    • Each concentration was tested 50 times (2 runs/day for 25 days) for each of 3 different lots.
    • Total precision samples per drug: 9 concentrations * 50 tests/concentration * 3 lots * 4 formats = 5400 tests.
  • Data Provenance: Samples were prepared by spiking known concentrations of drugs into negative urine samples. The origin of the negative urine itself is not specified but is implied to be human. The study was conducted "in-house" (Healgen Scientific LLC). These are prospective analytical studies.

• Cut-off Verification Test Set:

  • For each drug (Propoxyphene, Nortriptyline, EDDP) and for all formats (implicitly, as "different lots of each device" and "all formats" are mentioned in the interference study which follows this section):
    • 150 samples were used, equally distributed at -50% cut-off, cut-off, +25% cut-off, +50% cut-off concentrations. This means 37-38 samples per concentration.
    • Tested using three different lots of each device.
  • Data Provenance: Samples were prepared by spiking known concentrations of drugs into negative samples. Prospective analytical studies.

• Interference Test Set:

  • Not explicitly stated, but common interfering compounds (listed in pages 11-14) were tested at 100µg/mL in drug-free urine and in target drug urine (at 25% above cut-off).
  • Tested using three batches of each device for all formats.
  • Data Provenance: Prepared samples. Prospective analytical studies.

• Specificity (Cross-reactivity) Test Set:

  • Not explicitly stated, but drug metabolites and other components were tested.
  • Tested using three batches of each device for all formats. Lowest detectable concentration used to calculate cross-reactivity.
  • Data Provenance: Prepared samples. Prospective analytical studies.

• Effect of Urine Specific Gravity and Urine pH Test Set:

  • Urine samples with specific gravity 1.000 to 1.035 and pH 4 to 9.
  • Spiked with target drugs at 25% below and 25% above cut-off levels.
  • Tested using three batches of each device for all formats.
  • Data Provenance: Prepared samples. Prospective analytical studies.

• Method Comparison (Clinical Samples) Test Set:

  • For each drug (Propoxyphene, Nortriptyline, EDDP) and each format (Strip, Cassette, Cup, Dip Card):
    • 80 unaltered clinical urine samples were used (40 negative and 40 positive).
    • Total samples for method comparison = 3 drugs * 4 formats * 80 samples = 960 samples.
  • Data Provenance: "unaltered clinical samples" (implies human origin, retrospective or prospective collection not specified but usually retrospective for samples with confirmed status). The studies were performed "in-house."

• Lay-User Study Test Set:

  • For each drug (Propoxyphene, Nortriptyline, EDDP) and each format (Strip, Cassette, Cup, Dip Card):
    • 7 concentrations were evaluated: -100%, -75%, -50%, -25%, +25%, +50%, +75% of cut-off.
    • Each concentration was tested with 20 samples.
    • Total samples per drug/format: 7 concentrations * 20 samples/concentration = 140 samples.
    • Total samples across all drugs and implicitly all formats for lay user study (the table heading states "Propoxyphene Strip" but the preamble says "560 lay persons testing each of the Propoxyphene, the Nortriptyline and the EDDP devices." and then gives data for Strip, Cassette, DipCard, Cup formats. It is most logical that each lay person tests one sample of one format for one drug.) So, if each of 560 lay persons tested one sample for propoxyphene, 560 for nortriptyline, and 560 for EDDP (total 1680 individuals), the sample numbers in the tables would represent a subset or a summary of this. The tables show 20 samples per concentration level. It's more plausible that the lay users tested 140 different samples per drug, one sample per lay user, for each format specifically.
    • The tables specify "Number of samples" as 20 for each concentration level. If the tables represent the total combined results across all lay users, then the total number of distinct samples tested for each drug/format combination would be 7 concentrations * 20 samples/concentration = 140 samples * 4 formats (assuming tables were just representative) = 560 samples.
  • Data Provenance: Urine samples were prepared by spiking drugs into drug-free pooled urine specimens. The concentrations were confirmed by GC/MS. The study was performed at "three intended user sites." Prospective study design with prepared samples.

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

• Ground Truth Method: Gas Chromatography/Mass Spectrometry (GC/MS) was used as the confirmatory method for all studies involving quantitative drug concentrations, including precision, cut-off verification, and method comparison with clinical samples, and lay-user studies.
• Number/Qualifications of Experts: The document details the use of "three different operators" for precision studies and "three different laboratory assistants" for method comparison studies. It does not mention experts establishing GC/MS ground truth, as GC/MS is an objective analytical method. The results were confirmed by GC/MS, implying that qualified personnel performed these tests, but no specific number or qualifications are given for the GC/MS operators.

4. Adjudication Method for the Test Set:

• Analytical Studies (Precision, Cut-off, Interference, Specificity, Specific Gravity/pH): No explicit adjudication method is mentioned. The results are quantitative (GC/MS confirmation for preparation) or directly interpreted by operators judging the presence/absence of a line on the qualitative test. For precision, the results are aggregates (e.g., "50-/0+"), indicating consensus or direct reading rather than an adjudication process between human readers.
• Method Comparison (Clinical Samples): "Operators ran 80 (40 negative and 40 positive) unaltered clinical samples...compared to GC/MS results." "Three different laboratory assistants" interpreted the test results of the devices. The individual results from each viewer (Viewer A, B, C) are presented. GC/MS served as the definitive ground truth, so the comparison is directly between the device's output (as read by an operator) and the GC/MS result. Discrepancies are listed, highlighting where an operator's reading differed from GC/MS. No formal adjudication among the three laboratory assistants is described; their individual results are reported and compared to the GC/MS ground truth.
• Lay-User Study: Lay persons tested the device and results were compared to GC/MS. No adjudication among lay users is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study or AI: The device is a qualitative immunochromatographic assay (rapid test strip/cassette/cup/dip card), not an AI-powered diagnostic device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not applicable and not performed. The studies involved human readers (laboratory assistants, lay users) interpreting the results of the rapid tests directly.

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

• No standalone algorithm: As stated above, this is a rapid diagnostic test, not an AI or algorithm-based device. Performance is inherently tied to human visual interpretation of the test line. Therefore, a standalone (algorithm-only) performance study was not applicable and not performed. The "device performance" refers to the entire system including the physical test and its visual interpretation.

7. The Type of Ground Truth Used:

• GC/MS (Gas Chromatography/Mass Spectrometry): This was the primary method used to establish ground truth for all samples with known drug concentrations (prepared samples for precision, cut-off, interference, specificity, specific gravity/pH, and lay-user studies) and for the "unaltered clinical samples" used in the method comparison study. GC/MS is a highly sensitive and specific analytical technique considered the gold standard for confirmatory drug testing in urine.

8. The Sample Size for the Training Set:

• Not applicable: These are immunochromatographic assays, not machine learning or AI models. There is no "training set" in the context of developing a learning algorithm. The device's performance is determined by its chemical and biological components and manufacturing quality, not trained data.

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

• Not applicable: As there is no training set for an AI/ML algorithm, this question does not apply. The ground truth for evaluating the device's performance (i.e., for the test sets) was established using GC/MS, as detailed in point 7.

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