(48 days)
AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamine, Phencyclidine. Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch
The document describes the performance characteristics and studies for the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests, which are qualitative drug detection devices for human urine.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for qualitative drug tests are typically based on the correct classification of samples, especially around the cutoff concentration. The reported device performance is presented as the percentage of correct results at various concentrations relative to the cutoff. For the purpose of this table, "Acceptance Criteria" will be interpreted as the expectation of high accuracy, particularly at concentrations significantly above or below the cutoff, and reasonable performance around the cutoff. The data provided primarily focuses on the "lay-user study" for all drugs listed.
| Drug (Cut-off level) | Test Type | Sample Concentration | Acceptance Criteria (Implied) | Reported Performance (Percentage of correct results) |
|---|---|---|---|---|
| Amphetamine (AMP - 500 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (132 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (262 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (381 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| +25% Cutoff (637 ng/mL) | High Positive | 95% Positive (19/20) | ||
| +50% Cutoff (765 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (884 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Secobarbital (BAR - 300 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (80 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (160 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (229 ng/mL) | 100% Negative | 90% Negative (18/20) | ||
| +25% Cutoff (368 ng/mL) | High Positive | 95% Positive (19/20) | ||
| +50% Cutoff (447 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (528 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Buprenorphine (BUP - 10 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (2.4 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (4.6 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (7.7 ng/mL) | 100% Negative | 95% Negative (19/20) | ||
| +25% Cutoff (13.2 ng/mL) | High Positive | 95% Positive (19/20) | ||
| +50% Cutoff (15.2 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (16.9 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Oxazepam (BZO - 300 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (78 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (157 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (220 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| +25% Cutoff (382 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| +50% Cutoff (461 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (531 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Cocaine (COC - 150 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (39 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (80 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (115 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| +25% Cutoff (192 ng/mL) | High Positive | 95% Positive (19/20) | ||
| +50% Cutoff (221 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (268 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| EDDP (300 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (73 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (154 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (231 ng/mL) | 100% Negative | 90% Negative (18/20) | ||
| +25% Cutoff (376 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| +50% Cutoff (464 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (533 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Methylenedioxy-methamphetamine (MDMA - 500 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (122 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (265 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (386 ng/mL) | 100% Negative | 95% Negative (19/20) | ||
| +25% Cutoff (633 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| +50% Cutoff (768 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (890 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Methamphetamine (MET - 500 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (134 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (259 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (383 ng/mL) | 100% Negative | 90% Negative (18/20) | ||
| +25% Cutoff (637 ng/mL) | High Positive | 95% Positive (19/20) | ||
| +50% Cutoff (771 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (889 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Morphine (MOR - 300 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (78 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (154 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (229 ng/mL) | 100% Negative | 95% Negative (19/20) | ||
| +25% Cutoff (369 ng/mL) | High Positive | 95% Positive (19/20) | ||
| +50% Cutoff (457 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (530 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Methadone (MTD - 300 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (73 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (146 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (232 ng/mL) | 100% Negative | 90% Negative (18/20) | ||
| +25% Cutoff (379 ng/mL) | High Positive | 95% Positive (19/20) | ||
| +50% Cutoff (446 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (521 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Oxycodone (OXY - 100 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (28 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (48 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (79 ng/mL) | 100% Negative | 95% Negative (19/20) | ||
| +25% Cutoff (129 ng/mL) | High Positive | 95% Positive (19/20) | ||
| +50% Cutoff (147 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (179 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Phencyclidine (PCP - 25 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (8 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (14 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (21 ng/mL) | 100% Negative | 90% Negative (18/20) | ||
| +25% Cutoff (30 ng/mL) | High Positive | 95% Positive (19/20) | ||
| +50% Cutoff (39 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (48 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Propoxyphene (PPX - 300 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (71 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (152 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (228 ng/mL) | 100% Negative | 95% Negative (19/20) | ||
| +25% Cutoff (382 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| +50% Cutoff (455 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (522 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Nortriptyline (TCA - 1000 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (265 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (514 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (763 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| +25% Cutoff (1279 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| +50% Cutoff (1531 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (1782 ng/mL) | 100% Positive | 100% Positive (20/20) | ||
| Marijuana (THC - 50 ng/mL) | Lay User | -100% Cutoff (0 ng/mL) | 100% Negative | 100% Negative (20/20) |
| -75% Cutoff (14 ng/mL) | 100% Negative | 100% Negative (20/20) | ||
| -50% Cutoff (27 ng/mL) | 100% Negative | 100% Negative (170/170) | ||
| -25% Cutoff (39 ng/mL) | 100% Negative | 95% Negative (19/20) | ||
| +25% Cutoff (60 ng/mL) | High Positive | 95% Positive (19/20) | ||
| +50% Cutoff (78 ng/mL) | 100% Positive | 100% Positive (40/40) | ||
| +75% Cutoff (84 ng/mL) | 100% Positive | 100% Positive (20/20) |
2. Sample Size Used for the Test Set and the Data Provenance
-
Analytical Performance (Precision, Specificity, Interference, Effect of Urine Specific Gravity and pH):
- Sample Size: For precision studies, samples were prepared at various concentrations (-100% to +100% cutoff). Each concentration was tested with 3 lots of devices, 2 runs per day for 25 days, resulting in 50 individual tests per concentration per lot (2 runs/day * 25 days = 50). This totals approximately 400 tests per drug per lot per device type (8 concentrations * 50 tests).
- For Interference, Specificity, and Effect of Urine Specific Gravity/pH studies, urine samples were tested using three lots of each device at 25% below and 25% above Cut-Off levels (and drug-free urine for interference). Specific sample numbers are not explicitly stated for these sub-studies but imply multiple tests per lot.
- Data Provenance: The analytical studies were performed in-house, meaning within the manufacturer's or an affiliated laboratory. The data is thus prospective for the purpose of these device validations. The "country of origin" is not explicitly stated for the source of base urine samples, but the manufacturer is based in Hangzhou, China. The drugs were "spiked" into negative samples.
-
Comparison Studies (with GC/MS):
- Sample Size: 80 unaltered clinical samples (40 negative and 40 positive) for each drug (AMP500, COC150, MET500) were used for each device (Panel Dip and Quick Cup).
- Data Provenance: The samples were "unaltered clinical samples," implying these were real-world samples. The study was performed in-house. The country of origin of these clinical samples is not specified, but given the manufacturer's location, they are likely from China or a region where the manufacturer has access to clinical samples. This is a retrospective analysis against a gold standard.
-
Lay-user study:
- Sample Size: 310 lay persons for each device format (Panel Dip and Quick Cup). Urine samples were prepared at various concentrations (-100%, -75%, -50%, -25%, +25%, +50%, +75% of the cutoff). The exact breakdown of how these 310 lay users were distributed across the different concentrations is shown in the tables (e.g., for AMP, 20 samples at -100% Cutoff, 170 at -50% Cutoff, etc., which sums to 310).
- Data Provenance: The urine samples were "spiked drugs into drug free-pooled urine specimens." This indicates the samples were laboratory-prepared, not unaltered clinical samples. The study was conducted at "three intended user sites," but their location (country) is not specified. This is a prospective study using simulated clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Analytical Performance (Precision, Specificity, Interference): Ground truth established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an analytical chemical method, not by human experts. The drug concentrations in spiked samples were confirmed by LC/MS.
- Comparison Studies (with GC/MS): Ground truth established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the gold standard confirmatory method for drug testing. This is a laboratory-based analytical method, not human expert interpretation.
- Lay-user study: Ground truth established by LC/MS to confirm the drug concentrations in the spiked urine samples.
It's important to note that for these in vitro diagnostic devices, the "experts" in establishing ground truth are typically the highly precise analytical instruments (GC/MS, LC/MS) not human readers as would be the case for imaging studies.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
- Analytical Performance & Lay-user study: No adjudication method explicitly described as the ground truth was an objective measurement by LC/MS. The results are compared directly to the known spiked concentrations confirmed by LC/MS.
- Comparison Studies (with GC/MS): No adjudication method explicitly described. The device results were compared directly against the GC/MS results. The "Viewers" (human operators) for the dip cards/quick cups for AMP, COC, and MET showed some discordant results with GC/MS, but there is no mention of a process to adjudicate these discrepancies among the viewers or with the GC/MS result.
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 MRMC comparative effectiveness study was done. The device is a rapid test (lateral flow immunoassay) which relies on visual interpretation of lines, not complex image analysis or AI.
- The "Comparison Studies" involved three "laboratory assistants" (referred to as Viewer A, B, C) manually interpreting the device results against GC/MS. This is a multi-reader study, but it's not a comparative effectiveness study of human readers with vs. without AI. It assesses the consistency of human interpretation of the device results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The devices are qualitative lateral flow immunoassays designed for human visual interpretation. They are not AI algorithms; their performance is intrinsically tied to human reading. The "Performance Characteristics" section covers the analytical performance of the device components themselves, independent of human interpretation to a logical degree (e.g., cross-reactivity, stability).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth used for all performance studies (Analytical Performance, Comparison Studies, and Lay-user study) was analytical confirmation by either LC/MS or GC/MS. These are highly sensitive and specific laboratory methods considered the gold standard for drug detection and quantification in urine.
8. The sample size for the training set
- The document describes the performance of a rapid diagnostic test device (immunoassay), not a machine learning or AI algorithm that typically requires a distinct training set. Therefore, there is no specific "training set" as understood in the context of AI/ML development mentioned for the device itself.
- The device's internal parameters (e.g., antibody binding characteristics) would be developed and optimized by the manufacturer during product development, but this process doesn't constitute a "training set" in the AI sense.
9. How the ground truth for the training set was established
- As there is no "training set" for an AI/ML algorithm mentioned, this question is not applicable. The device's performance is based on its inherent chemical and immunological properties.
§ 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).