Search Results

Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine 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 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 over-the-counter and for prescription use.

Healgen Oxycodone Test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when prescription drug Oxycodone 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 Oxycodone 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 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 over-the-counter and for prescription use.

Healgen Amphetamine Test and Healgen Oxycodone Test are immunochromatographic assays for Amphetamine and Oxycodone. Each assay test is a lateral flow system for the qualitative detection of Amphetamine and Oxycodone (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 document describes the performance characteristics and studies for the Healgen Amphetamine Test and Healgen Oxycodone Test, which are immunochromatographic assays for the qualitative determination of Amphetamine and Oxycodone in human urine.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but presents performance data for several metrics. Based on the context of immunoassay device submission, the implicit acceptance criteria are that the device should accurately classify samples as positive or negative relative to the established cut-off concentrations, and demonstrate precision, specificity, and lack of significant interference from common substances.

Here's a table summarizing the performance:

2. Sample Sizes and Data Provenance

• Precision Study (Test Set):

  • For each drug (Amphetamine, Oxycodone), for each of 4 device formats (Strip, Cassette, Cup, Dip Card), and for each of 3 lots: 50 samples were analyzed per drug concentration level.
  • Total samples for precision: 2 drugs * 4 formats * 3 lots * 9 concentration levels * 50 samples/level = 10,800 sample analyses (if each level was unique per lot).
  • Data Provenance: The samples were "drug free urine samples" spiked with drugs or collected as "negative samples." The exact country of origin is not specified but implied to be in a laboratory setting for controlled spiking. This is a prospective study in a controlled lab environment.
  • Ground Truth: Confirmed by GC/MS.

• Cut-off Verification Study (Test Set):

  • Total samples: 150 samples (equally distributed at -50%, -25%, cut-off, +25%, +50% cut-off) for each drug using three different lots of each device format.
  • This implies 2 drugs * 4 formats * 3 lots * 5 concentration levels * ~10 samples/level = Approximately 1200 sample analyses.
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared spiked samples. This is a prospective study.
  • Ground Truth: Determined by preparation based on known cut-off concentrations.

• Interference Study (Test Set):

  • Various interfering substances added to drug-free urine and urine with target drugs at 25% above cut-off.
  • Tested using three batches of each device for all formats.
  • Data Provenance: Not specified, likely laboratory-prepared samples. Prospective.
  • Ground Truth: Known concentrations of interfering substances and target analytes.

• Specificity (Cross-reactivity) Study (Test Set):

  • Drug metabolites and other components were tested using three batches of each device for all formats.
  • Data Provenance: Not specified, likely laboratory-prepared samples. Prospective.
  • Ground Truth: Known concentrations of cross-reactant compounds.

• Effect of Urine Specific Gravity and pH Study (Test Set):

  • Urine samples with varying specific gravity (1.000 to 1.035) or pH (4 to 9) were spiked with target drugs at -25% and +25% cut-off levels.
  • Tested using three batches of each device for all formats.
  • Data Provenance: Not specified, likely laboratory-prepared samples. Prospective.
  • Ground Truth: Known specific gravity, pH, and drug concentrations.

• Method Comparison Study (Clinical Samples - Test Set):

  • For each drug (Amphetamine, Oxycodone) and each device format: 80 unaltered clinical samples (40 negative and 40 positive) were run.
  • Total samples for method comparison: 2 drugs * 4 formats * 80 samples/format = 640 clinical samples.
  • Data Provenance: "Unaltered clinical samples" - country of origin is not specified, but they are patient samples. This is a retrospective evaluation of collected samples.
  • Ground Truth: Confirmed by GC/MS.

• Lay-User Study (Test Set):

  • Amphetamine: 140 lay persons tested each format of the device. This implies 140 individuals * 4 formats = 560 separate tests, each using one sample. (The text states "Total of 1120 individuals performed the study," which seems to imply 140 persons for Amphetamine and 140 for Oxycodone, each testing all 4 formats, or it means 140 unique individuals per format. The breakdown states "230 females and 330 males tested the Amphetamine samples," totaling 560 individuals specifically for Amphetamine, and similarly for Oxycodone. This suggests 560 individuals for Amphetamine and 560 for Oxycodone. If each person tested only ONE sample, then 560 samples for Amphetamine, 560 for Oxycodone).
  • Each participant received one blind-labeled sample. Samples were prepared at 7 concentration levels (0, 250, 500, 750, 1250, 1500, 1750 ng/mL for Amphetamine; 0, 25, 50, 75, 125, 150, 175 ng/mL for Oxycodone). The tables show 20 samples per concentration level.
  • Total samples evaluated by lay users: 2 drugs * 4 formats * 7 concentration levels * 20 samples/level = 1120 samples.
  • So, most likely, 1120 unique individuals tested one sample each.
  • Data Provenance: Laboratory-prepared spiked urine samples. Prospective.
  • Ground Truth: Confirmed by GC/MS.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• GC/MS (Gas Chromatography/Mass Spectrometry) is repeatedly stated as the "preferred confirmatory method" and the method used to confirm drug concentrations. GC/MS is an objective analytical method and does not rely on expert interpretation in the same way clinical imaging or pathology might. Therefore, no "experts" in the subjective sense were used to establish the ground truth for the test set for the concentrations of the drugs. The validity of GC/MS results depends on the expertise and accreditation of the laboratory performing the tests.

• For the Method Comparison Studies, three "laboratory assistants" performed the device readings. While they are readers, their classification (positive/negative) is compared to the objective GC/MS ground truth, not used to establish it.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• The document does not describe an adjudication method for the test set interpretations. The ground truth (GC/MS) is an objective analytical measurement, not a subjective interpretation requiring adjudication.
• For the Precision studies, different operators evaluated the lots, but the results are presented as counts of positive/negative for a given concentration, not as a consensus interpretation.
• For the Method Comparison Studies, three "laboratory assistants" read the devices. Their individual results are reported against the GC/MS. There is no mention of an adjudication process among these three readers.
• For the Lay-User Study, each lay user's result on a single sample was compared directly to the GC/MS ground truth; no adjudication occurred.

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, an MRMC comparative effectiveness study was not performed.
• This device is a rapid, qualitative immunochromatographic assay (a "drug test strip/cassette/cup/dip card"), which requires visual interpretation of lines. It is not an AI-powered diagnostic tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable to this device.
• The "readers" in the method comparison study were human (laboratory assistants), and in the lay-user study, they were laypersons. Their performance was evaluated in a standalone manner against a reference standard (GC/MS) for the device itself, not in an AI-assisted workflow.

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

• Yes, in effect, a standalone performance was evaluated. The device itself (the immunochromatographic assay) is the "algorithm" here, and its performance is judged by the chemical reaction and visual line development. The precision, cut-off verification, interference, specificity, and specific gravity/pH studies evaluated the intrinsic performance of the device's chemical assay independent of human interpretation variability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The primary ground truth used for all performance characteristics (precision, cut-off verification, interference, specificity, method comparison, and lay-user study) was Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is an objective, highly accurate analytical method for quantifying drug concentrations, making it the gold standard for confirming drug presence and concentration in urine samples.

8. The sample size for the training set

• This document describes a medical device (immunochromatographic assay) that does not use artificial intelligence or machine learning. Therefore, there is no training set in the context of AI/ML model development. The device's performance is based on its chemical and biological design, manufacturing, and intrinsic properties, which are optimized during product development (not "training").

9. How the ground truth for the training set was established

• As there is no AI/ML component, there is no training set or corresponding ground truth establishment process in the AI/ML sense. The "ground truth" for evaluating the performance during development and validation phases (analogous to how a training set might be used in AI) would have been established through controlled experiments using known concentrations of analytes and reference methods like GC/MS to ensure the device's chemical reagents and design function as intended.

Ask a specific question about this device