(29 days)
Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 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 prescription and for over-the-counter use.
Healgen Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 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 prescription and for over-the-counter use.
Healgen Methamphetamine Test is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 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 Amphetamine Test, Healgen Cocaine Test and Healgen Methamphetamine Test are immunochromatographic assays for Amphetamine, Cocaine and Methamphetamine. Each assay test is a lateral flow system for the qualitative detection of Amphetamine, Benzoylecgonine and Methamphetamine (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 several tests conducted to prove the performance of the Healgen Amphetamine Test, Healgen Cocaine Test, and Healgen Methamphetamine Test devices.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" through a table or specific thresholds that define success. Instead, it presents performance characteristic studies (precision, cut-off verification, interference, specificity, and comparison to GC/MS) and a lay-user study.
Based on the presented data, the implicit acceptance criteria appear to be:
- Precision: Consistent results across different lots, operators, and concentration levels, especially for samples near the cut-off.
- Cut-off Verification: Accurate classification of samples at or near the specified cut-off concentrations for each drug.
- Interference: No false positive or false negative results due to common interfering substances in urine.
- Specificity: Low or no cross-reactivity with structurally similar but non-target compounds at expected physiological concentrations.
- Method Comparison (with GC/MS): High concordance with GC/MS results, especially for clearly negative and clearly positive samples, with reasonable performance around the cut-off.
- Lay-user usability: High percentage of correct results by lay users and clear instructions for use.
Here's a summary table of the reported device performance for key aspects:
| Performance Aspect | Acceptance Criteria (Implicit, based on study) | Reported Device Performance (Summary from tables) |
|---|---|---|
| Precision | Consistent classification (positive/negative) at various concentrations, particularly 100% agreement at -100% to -25% cut-off (negative) and +25% to +100% cut-off (positive). Variability allowed at cut-off. | Observed: For all three analytes (Amphetamine, Cocaine, Methamphetamine) across all formats (Strip, Cassette, Dip Card, Cup) and 3 lots: |
- 100% Negative results from -100% to -25% cut-off concentrations (e.g., 50-/0+ means 50 negative, 0 positive).
- 100% Positive results from +25% to +100% cut-off concentrations (e.g., 50+/0- means 50 positive, 0 negative).
- At Cut-off Concentration: Mixed results (e.g., Amphetamine Strip: Lot 1: 23-/27+, Lot 2: 26-/24+, Lot 3: 26-/24+). This variability at the cut-off is expected for qualitative tests. |
| Cut-off | Accurate detection at specified cut-off concentrations. | Observed: For Amphetamine (500 ng/mL), Cocaine (150 ng/mL), and Methamphetamine (500 ng/mL): - All samples at and above +25% cut-off were positive.
- All samples at and below -25% cut-off were negative.
The specified cut-off values were verified. |
| Interference | No interference (false positives or negatives) by common physiological substances or over-the-counter medications at specified concentrations (100 ug/mL). | Observed: Numerous listed compounds (e.g., Acetophenetidin, Acetylsalicylic Acid, Caffeine, Ibuprofen, etc.) showed no interference at 100 ug/mL for all three drug tests and formats when tested with drug-free and +25% cut-off spiked samples. |
| Specificity | Acceptable levels of cross-reactivity with structurally similar compounds. | Observed: Each drug test showed varying degrees of cross-reactivity with related substances. For example: - Amphetamine: D-Amphetamine (100%), D,L-Amphetamine (67%), L-Amphetamine (3%), Phentermine (77%). Very low cross-reactivity with d-Methamphetamine ( 50 years."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Precision, Cut-off, Interference, Specificity, and Lay-user Studies: The ground truth for these studies was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method for drug concentration determination. The individuals performing the GC/MS analysis are typically trained analytical chemists or laboratory technicians, but their specific qualifications are not detailed in the document.
- Method Comparison Study: The ground truth for the 80 unaltered clinical samples was established by GC/MS. As above, specific qualifications of the GC/MS operators are not provided. The device results were then compared to these GC/MS ground truth results.
4. Adjudication method for the test set
- Precision, Cut-off, Interference, Specificity, and Lay-user Studies: No explicit adjudication method is mentioned for the ground truth. The ground truth was set by scientific preparation and GC/MS confirmation of samples. For the device results, multiple operators conducted the tests (3 operators for precision, cut-off; 3 batches for interference/specificity), but it's not stated that their results were adjudicated against each other; they are presented individually or as aggregate performance.
- Method Comparison Study: The document lists results for Viewer A, Viewer B, and Viewer C separately. There is no explicit mention of an adjudication method for comparing interpretations between these viewers or for resolving discordant results by the device itself. The device results from each viewer are directly compared to the GC/MS ground truth.
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 done. This document describes the performance of in-vitro diagnostic test kits (dipstick, cassette, cup formats) for qualitative drug detection by visual interpretation. These are standalone devices, not AI-assisted reading systems.
- Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence, the "Analytical Performance" section (Precision, Cut-off, Interference, Specificity) and elements of the "Method Comparison Studies" (comparison to GC/MS ground truth) represent standalone performance of the device itself (the immunochromatographic assay reaction and visual line formation), without explicit human 'interpretation' as the primary variable. The visual reading done by operators/viewers in the precision and method comparison studies still involves human interpretation of the color lines.
- However, the Lay-user study specifically evaluated human-in-the-loop performance (lay users interpreting the device according to instructions). Other sections primarily focus on the inherent analytical performance of the test strips/cassettes/cups.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The primary ground truth used throughout these studies is GC/MS (Gas Chromatography/Mass Spectrometry), which is an objective chemical analytical method considered the gold standard for confirming drug concentrations in toxicology.
- For the lay user study, the ground truth was also established by GC/MS for the prepared spiked samples.
8. The sample size for the training set
- The document describes premarket notification studies for an in-vitro diagnostic device. It does not mention a "training set" in the context of machine learning or AI models.
- The device is a laboratory assay; it does not involve algorithms that require training data. The "training" in this context would refer to the development and optimization of the chemical reagents and manufacturing process, which are not detailed as a "training set" in a data science sense.
9. How the ground truth for the training set was established
- N/A, as there is no "training set" in the context of data for an AI/ML algorithm.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).