(121 days)
AssureTech Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use.
AssureTech Cocaine Tests are immunochromatographic assays for the qualitative determination of Benzoylecgonine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use.
AssureTech Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 2000 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use.
The AssureTech Amphetamine Tests, AssureTech Cocaine Tests, and AssureTech Morphine Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Benzoylecgonine and Morphine (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
Here's a summary of the acceptance criteria and study details for the AssureTech Amphetamine, Cocaine, and Morphine Tests, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as distinct, quantifiable thresholds for overall device performance (e.g., minimum sensitivity/specificity). Instead, it presents the results of various studies which demonstrate the device's acceptable performance in several analytical and user-related aspects. The performance is summarized below from the provided tables and text.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Consistent results across multiple lots and concentrations, accurately differentiating positive and negative samples around the cut-off. | For all three drug tests (Amphetamine, Cocaine, Morphine) and all device formats (Strip, Dip Card, Turn-Key Split Cup, Quick Cup): |
- Samples at -100%, -75%, -50% cut-off consistently showed 50-/0+ (negative results, 0 false positives).
- Samples at +25%, +50%, +75%, +100% cut-off consistently showed 50+/0- (positive results, 0 false negatives).
- At the cut-off concentration, results showed a mix of positive and negative, as expected (e.g., Amphetamine Strip Lot 1: 12-/38+; meaning 12 negative and 38 positive out of 50 tests). This demonstrates the ability to differentiate near the cut-off. |
| Cut-off | Accurate detection at and around defined cut-off concentrations. | For all three drug tests: - All samples at and above +25% Cut-Off were positive.
- All samples at and below -25% Cut-Off were negative.
Verified Cut-off Values: - d-Amphetamine: 1000 ng/mL
- Benzoylecgonine: 300 ng/mL
- Morphine: 2000 ng/mL |
| Interference | No significant interference from common physiological/pathological substances or drugs. | No interference observed for a wide range of compounds (listed in detail for each drug) at 100µg/mL. No differences observed across different device formats. |
| Specificity | Correct identification of target analytes and appropriate cross-reactivity with related compounds. | Detailed cross-reactivity tables provided, showing expected reactivity to metabolites and related compounds, and negative results for unrelated substances. For example: - Amphetamine: D-Amphetamine 100%, L-Amphetamine 5%, D,L-Amphetamine 33%.
- Cocaine: Benzoylecgonine 100%, Cocaine HCl 40%.
- Morphine: Morphine 100%, Codeine 200%, Acetylmorphine 80%. |
| Effect of Urine Specific Gravity and pH | No impact on results within biological ranges. | All samples spiked with target drugs at +/-25% Cut-Off within specific gravity (1.000-1.035) and pH (4-9) ranges yielded expected results (positive at +25% Cut-Off, negative at -25% Cut-Off). No differences observed across different device formats. |
| Method Comparison (vs. GC/MS) | High concordance with GC/MS results, especially for samples far from the cut-off. Discordant results should be concentrated near the cut-off. | Generally high concordance with GC/MS. Discordant results (where device result differs from GC/MS) primarily occur in samples with concentrations near the cut-off (between -50% and +50% of the cut-off), which is an expected characteristic of qualitative rapid tests. Specific numbers of concordant and discordant results are detailed for each drug and device format. |
| Lay-user Study (Correct Results) | High percentage of correct results by lay users for samples significantly above or below the cut-off. | For all three drug tests (Amphetamine, Cocaine, Morphine) and all device formats: 100%correct results for samples at -100%, -75%, -50% cut-off.100%correct results for samples at +50%, +75% cut-off.- Performance slightly lower (e.g., 90-95%) for samples near the +/-25% cut-off, which is expected for qualitative tests. |
| Lay-user Study (Ease of Use) | Instructions easily understood and followed by lay users. | All lay users indicated that the device instructions could be easily followed. The Flesch-Kincaid reading analysis showed a Grade Level of 7 for the package insert. |
2. Sample Size Used for the Test Set and Data Provenance:
-
Analytical Performance (Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH):
- Precision: For each drug and each device format, 3 lots were tested. For each lot, 8 concentrations were evaluated, with 50 tests per concentration (2 runs per day for 25 days). This amounts to 3 (lots) * 8 (concentrations) * 50 (tests/concentration) = 1200 tests per drug per device format.
- Cut-off: 150 samples (equally distributed at -50%, -25%, Cut-Off, +25%, +50% Cut-Off) were tested using three different lots of each device by three different operators. This sums up to 150 (samples) * 3 (lots) * 3 (operators) = 1350 tests per drug per device format.
- Interference/Specificity/Effect of Urine Specific Gravity and pH: Samples were prepared with interfering substances/varied conditions and spiked with target drugs at 25% below and 25% above Cut-Off levels. Tested using three batches of each device. Specific sample numbers for these studies are not explicitly provided beyond these descriptions.
- Data Provenance: Not specified, but generally analytical performance studies are conducted internally by the manufacturer. No country of origin is mentioned. These are retrospective studies in the sense that samples are prepared/manipulated for the experiment.
-
Method Comparison Studies (vs. GC/MS):
- For each drug and each device format, 80 unaltered clinical samples were tested by three laboratory assistants. These samples were categorised as 10 Negative, 20 Low Negative (less than -50%), 10 Near Cutoff Negative (between -50% and cutoff), 15 Near Cutoff Positive (between cutoff and +50%), and 25 High Positive (greater than +50%).
- Total samples per drug (e.g., Amphetamine) across all device types: 80 (samples) * 4 (device formats) = 320 samples (clinical).
- Total tests per drug: 80 (samples) * 3 (viewers) * 4 (device formats) = 960 tests (clinical).
- Data Provenance: "Unaltered clinical samples" - implies prospective or retrospectively collected human urine samples. Country of origin not specified.
-
Lay-user Study:
- 1638 lay persons were involved. Each participant tested 1 blind-labeled sample.
- Samples were prepared at 7 different concentrations for each drug and device (negative, +/-75%, +/-50%, +/-25% of the cutoff).
- For each drug and each device format, there were 21 samples per concentration. So, 7 (concentrations) * 21 (samples/concentration) = 147 samples per drug per device format.
- Therefore, 147 samples * 3 (drugs) * 4 (device formats) = 1764 samples in total for the lay-user study. Given there were 1638 lay persons, this suggests some lay persons might have tested multiple devices/drugs, or the "number of samples" refers to unique sample types at each concentration. The phrasing "Each participant was provided with... 1 blind labeled sample and a device" implies each of the 1638 participants tested one particular drug/device combination sample. The specific breakdown of which participant tested which of the 1764 total samples isn't detailed, but the total number of lay users is 1638.
- Data Provenance: "three intended user sites." Implied prospective data collection from human lay users. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Analytical Performance & Lay-user Study Test Sets: The ground truth for these samples was established using GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate chemical method used as the "preferred confirmatory method" for drug testing. No human experts were involved in establishing the ground truth for these controlled samples; it's a quantitative chemical analysis.
- Method Comparison Study Test Set: The ground truth for the 80 unaltered clinical samples was also established through GC/MS.
- Qualifications of Experts: Not applicable, as GC/MS is the ground truth determinant. The "laboratory assistants" and "lay persons" were the ones performing the device tests, not establishing the ground truth.
4. Adjudication Method (for the test set):
- Analytical Performance & Lay-user Study: The ground truth was based on GC/MS results. The device results were compared directly to the GC/MS quantitative concentration relative to the cut-off. No human adjudication method was described as the ground truth was objective chemical analysis.
- Method Comparison Study: The ground truth was based on GC/MS results. Discordant results (where the viewer's result differed from the GC/MS) are reported individually for each viewer. There is no mention of an adjudication process among the three laboratory assistants (Viewers A, B, C) for these comparisons.
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 a medical device (drug screening tests) which is not an AI-powered image analysis tool. It is a qualitative immunoassay. The "Viewers" mentioned in the method comparison study are laboratory assistants reading the results of the strips, not radiologists or medical professionals interpreting AI output. Therefore, there is no discussion of AI assistance or effect size on human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone performance data is presented, but not for an algorithm. The devices are qualitative immunochromatographic assays. Their "standalone" performance is assessed by comparing their output (presence/absence of a line, indicating positive/negative) directly against the GC/MS ground truth in various analytical studies (precision, cut-off, interference, specificity, specific gravity/pH effects).
- The "Method Comparison Studies" where three laboratory assistants read the devices can be seen as testing the device's performance with a human-in-the-loop (laboratory assistant).
- The "Lay-user study" specifically evaluates the device's performance with a human-in-the-loop (lay person), focusing on ease of use and ability to correctly interpret results.
- The closest to "algorithm only" performance comes from the precision and cut-off studies, where the device's inherent ability to react to specific concentrations is measured.
7. The type of ground truth used:
- The primary ground truth used for all performance studies (analytical, method comparison, and lay-user studies) was Gas Chromatography/Mass Spectrometry (GC/MS).
- GC/MS is referred to as the "preferred confirmatory method," making it the clinical gold standard for quantitative drug concentration in urine, providing an objective and highly accurate ground truth.
8. The sample size for the training set:
- This document is a 510(k) submission for an in-vitro diagnostic device (immunoassay), not an AI/Machine Learning algorithm. Therefore, there is no concept of a "training set" in the traditional AI sense described here. The device's performance is based on its chemical and biological design, not on being trained with data.
9. How the ground truth for the training set was established:
- As there is no training set for an AI/ML algorithm, this question is not applicable. The device's functionality is inherent to its design as an immunoassay.
§ 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).