(31 days)
The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, EDDP, d/l-Methadone, d-Methamphetamine, d1-Methylenedioxymethamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| 6-MAM | 6-Monoacetylmorphine | 10 |
| AMP | d-Amphetamine | 500 / 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 150 / 300 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine | 300 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | d-Methamphetamine | 500 / 1000 |
| MTD | d/l-Methadone | 300 |
| OPI | Morphine | 300 / 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | d-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-Δ9-THC-COOH | 50 |
The single or multi-test panels can consist of up to sixteen (16) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).
The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-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 Home Urine Drug Test Dip Card is a rapid qualitative immunoassay.
The device provides preliminary results for the detection of potential abuse of one or more at the cutoff concentrations of table below.
This is not a screening device to monitor prescription medication.
| CODE | SUBSTANCE | CUT-OFF (ng/mL) |
|---|---|---|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| ---------- | ---------------------- | ------------- |
| EDDP | EDDP | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | Ecstasy | 500 |
| OPI | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device.
This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.
Healgen Accurate Home Urine Drug Test Dip Card and Healgen Accurate Urine Drug Screen Dip Card are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a dip card format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
Here's a breakdown of the acceptance criteria and study information for the Healgen Accurate Urine Drug Screen Dip Card and Healgen Accurate Home Urine Drug Test Dip Card, based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria are implied by the reported performance, specifically the agreement rates with LC-MS/MS and within the lay user study, particularly around the established cut-off concentrations. A device is considered to meet the acceptance criteria if its performance demonstrates accurate qualitative detection of the target drugs at and around the specified cut-off concentrations.
Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Assessment Category | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | Consistent positive/negative results at concentrations significantly above/below cutoff. Mixed results at and near cutoff. | Generally 100% agreement for concentrations ±50% to ±100% of the cutoff. Mixed results at cutoff and ±25% of cutoff, indicating appropriate sensitivity at the threshold. |
| Analytical Specificity/Interference | No interference or cross-reactivity from specified non-structural compounds at 100 µg/mL. Acceptable cross-reactivity for structurally related analogs. | Extensive list of compounds showing "Not detected" or specific cross-reactivity percentages. pH (4-9) and specific gravity (1.000-1.035) showed no interference. |
| Method Comparison (Clinical Samples) | High agreement (concordance) with LC-MS/MS results, especially for clearly negative and clearly positive samples. | High concordance with LC-MS/MS, with discordant results primarily located near the cutoff concentrations. For example, for AMP (1000ng/mL), 0 false positives were seen among "Drug-Free" and "Low Negative" samples, and 0 false negatives among "High Positive" samples across all operators. |
| Lay Person Study | High agreement with expected results by lay users, demonstrating ease of use and accurate interpretation. Instructions should be easy to understand. | High agreement (mostly 90-100%) near and away from cutoff concentrations for various drugs for both configurations. All participants found instructions easy to understand, and the Flesch-Kincaid reading level was 7. |
| Stability | Device remains stable and performs within specifications for the claimed shelf life. | 24 months at 2-30℃ based on real-time stability study. |
Detailed Study Information:
2. Sample Size Used for the Test Set and Data Provenance:
- Precision/Reproducibility Study:
- For each drug and each concentration (-100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff, +100% cutoff), 50 tests were performed per lot.
- With 3 lots, this amounts to 150 tests per concentration per drug.
- There are 16 different drugs/cut-offs for which precision was tested. So, 16 drugs * 9 concentrations * 50 tests/concentration * 3 lots = 21,600 individual test results.
- Data Provenance: Not explicitly stated, but implies laboratory-prepared spiked samples using drug-free urine.
- Analytical Specificity/Interference Study:
- "drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples were tested using three lots of the device."
- "non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at 50% below and 50% above each corresponding cutoff."
- Sample Size: Not explicitly given as a total number of tests for all compounds but a significant number of tests were performed for each compound listed.
- Data Provenance: Laboratory-prepared spiked samples using drug-free urine.
- Method Comparison Study:
- Sample Size: 80 "unaltered urine clinical samples" (40 negative and 40 positive) for each drug.
- With 16 different drugs/cut-offs, this amounts to 16 drugs * 80 samples = 1280 clinical samples.
- These samples were tested by 3 operators, meaning 1280 samples * 3 operators = 3840 individual test results.
- Data Provenance: "Unaltered urine clinical samples." The country of origin is not specified but is likely the US given the FDA submission.
- Lay Person Study:
- Sample Size: 280 lay persons.
- 78 male and 62 female tested Configuration 1 (140 participants).
- 76 male and 64 female tested Configuration 2 (140 participants).
- Urine samples were prepared at 7 concentrations: -100%, +/-75%, +/-50%, +/-25% of the cutoff. Each participant received one blind-labeled sample.
- For each drug, 20 samples were prepared for each of the 7 concentrations, meaning 140 samples per drug.
- With 16 drugs, 16 drugs * 140 samples = 2240 samples. Since there were different configurations, the actual number of unique samples tested is likely higher.
- Data Provenance: Laboratory-prepared spiked samples using drug-free urine, presented to lay users.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Precision/Reproducibility, Analytical Specificity/Interference, and Lay Person Studies: The ground truth for these studies was established by LC-MS/MS confirming the spiked concentrations. No human experts were involved in establishing the ground truth for these specific tests.
- Method Comparison Study: The ground truth for this study was established using LC-MS/MS results. The document states that "The samples were blind labeled and compared to LC-MS/MS results." No human experts were used for establishing the ground truth beyond the analytical method itself.
4. Adjudication Method for the Test Set:
- Method Comparison Study: "The samples were blind labeled and compared to LC-MS/MS results." This suggests direct comparison to the LC-MS/MS ground truth, with no explicit human adjudication mentioned for discrepancies. The discordant results table shows instances where the dip card result differed from the LC-MS/MS result for individual operators, but there's no mention of a formal adjudication process involving multiple experts to re-evaluate the LC-MS/MS results or the dip card interpretations. The "Accurate Result" column in the discordant table appears to consistently follow the LC-MS/MS result.
- Lay Person Study: The results were generated by lay persons. The "Agreement (%)" indicates concordance with the known spiked concentration as confirmed by LC-MS/MS, not a consensus among lay users or experts evaluating their interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, 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 lateral flow immunoassay (a dip card), not an AI-powered diagnostic device. The studies evaluate the device's performance directly and its usability by laypersons, not the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable as the device is a manual, qualitative immunoassay. Its "standalone" performance is what is evaluated in the precision, specificity, and method comparison studies (excluding the lay person aspect). There is no algorithm or AI component. The interpretation is visual.
7. The Type of Ground Truth Used:
- LC-MS/MS (Liquid Chromatography-Mass Spectrometry), and its tandem mass-spectrometer versions (LC-MS/MS), were used as the preferred confirmatory method to establish ground truth for all analytical and method comparison studies. For the lay person study, the known spiked concentrations, confirmed by LC-MS/MS, served as the ground truth.
8. The Sample Size for the Training Set:
- This information is not provided in the document. As this is an immunoassay and not a machine learning model, the concept of a "training set" in the context of AI is not relevant. The device is developed and manufactured, and its performance is then validated.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set for an AI/ML model.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).