(29 days)
Accurate Multi Panel Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off |
|---|---|
| Amphetamine (AMP) | 1000 ng |
| Buprenorphine (BUP) | 10 ng |
| Secobarbital (BAR) | 300 ng |
| Oxazepam (BZO) | 300 ng |
| Cocaine (COC) | 300 ng |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng |
| Methamphetamine (MET) | 1000 ng |
| Methylenedioxymethamphetamine (MDMA) | 500 ng |
| Morphine (MOP 300/OPI 2000) | 300 ng |
| Methadone (MTD) | 300 ng |
| Oxycodone (OXY) | 100 ng |
| Phencyclidine (PCP) | 25 ng |
| Propoxyphene (PPX) | 300 ng |
| Nortriptyline (TCA) | 1000 ng |
| Marijuana (THC 50) | 50 ng |
level /mL /mL /mL /mL z/mL g/mL g/mL /mL g/mL or 2000 ng/mL g/mL g/mL g/mL g/mL g/mL 50 ng/mL
Accurate Multi Panel Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Accurate® Multi Panel Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine. Each Accurate® Multi Panel Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with desiccant in an aluminum pouch.
This document describes the performance of the "Accurate Multi Panel Drug Urine Test Cup" for detecting various drugs in human urine.
Here's an analysis based on your request:
Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by the results of the "Precision" and "Comparison Studies" sections, demonstrating the device's ability to accurately detect drugs at, above, and below specified cutoff concentrations. The core acceptance criterion for qualitative drug tests like this is often high agreement with a confirmed analytical method (LC/MS or GC/MS) and consistent performance around the cutoff.
Here's a table summarizing the reported device performance, based on the precision study results:
Table of Acceptance Criteria (Implicit) and Reported Device Performance (Precision Study: % Agreement for each concentration across 3 lots where 50 positive and 50 negative results would yield 100%)
The precision studies were performed across three different lots of the device. For each drug, the number of positive (+) and negative (-) results are reported out of 50 tests per concentration per lot.
For ease of understanding the acceptance, I interpret the "0-/50+" and "50-/0+" outcomes as 100% agreement for concentrations far from the cutoff (i.e., always negative for significantly below cutoff, and always positive for significantly above cutoff). The critical region is around the cutoff where some variability is expected and defined by the number of discordant results (mix of positive and negative).
| Drug (Cutoff) | % of Cutoff (LC/MS Conc. ng/mL) | Lot I (Neg/Pos) | Lot II (Neg/Pos) | Lot III (Neg/Pos) | Implied Acceptance Criterion (e.g., all samples below X ng/mL should be Negative, all samples above Y ng/mL should be Positive) | Performance (Agreement at each concentration) |
|---|---|---|---|---|---|---|
| BUP (10 ng/mL) | +100% (19.1) | 0-/50+ | 0-/50+ | 0-/50+ | All positive | 100% positive |
| +75% (16.1) | 0-/50+ | 0-/50+ | 0-/50+ | All positive | 100% positive | |
| +50% (15.2) | 0-/50+ | 0-/50+ | 0-/50+ | All positive | 100% positive | |
| +25% (12.9) | 1-/49+ | 1-/49+ | 2-/48+ | Predominantly positive (e.g., >80% positive) | 98%, 98%, 96% positive | |
| Cutoff (9.4) | 26-/24+ | 22-/28+ | 20-/30+ | Mix of positive/negative (e.g., ~50% agreement) | 48%, 56%, 60% positive (for LC/MS 9.4ng/mL) | |
| -25% (7.1) | 48-/2+ | 49-/1+ | 49-/1+ | Predominantly negative (e.g., >80% negative) | 96%, 98%, 98% negative | |
| -50% (5.4) | 50-/0+ | 50-/0+ | 50-/0+ | All negative | 100% negative | |
| -75% (2.4) | 50-/0+ | 50-/0+ | 50-/0+ | All negative | 100% negative | |
| -100% (0) | 50-/0+ | 50-/0+ | 50-/0+ | All negative | 100% negative | |
| PCP (25 ng/mL) | +100% (50.3) | 0-/50+ | 0-/50+ | 0-/50+ | All positive | 100% positive |
| ... (similar structure for all 15 drugs) | Cutoff (e.g. 25.0 for PCP) | Mix of -/+ | Mix of -/+ | Mix of -/+ | Around 50% agreement at LC/MS cutoff concentration is typical for qualitative tests. | Consistent with expectations for qualitative assays at cutoff |
| THC (50 ng/mL) | Cutoff (e.g. 50.2 for THC) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| OXY (100 ng/mL) | Cutoff (e.g. 98.4 for OXY) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| BAR (300 ng/mL) | Cutoff (e.g. 270.1 for BAR) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| BZO (300 ng/mL) | Cutoff (e.g. 307.9 for BZO) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| EDDP (300 ng/mL) | Cutoff (e.g. 300.7 for EDDP) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| MTD (300 ng/mL) | Cutoff (e.g. 314.6 for MTD) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| MOP (300 ng/mL) | Cutoff (e.g. 289.0 for MOP) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| PPX (300 ng/mL) | Cutoff (e.g. 308.6 for PPX) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| MDMA (500 ng/mL) | Cutoff (e.g. 516.6 for MDMA) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| TCA (1000 ng/mL) | Cutoff (e.g. 1091.2 for TCA) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| OPI (2000 ng/mL) | Cutoff (e.g. 2008.3 for OPI) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| COC (300 ng/mL) | Cutoff (e.g. 303.1 for COC) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| AMP (1000 ng/mL) | Cutoff (e.g. 1091.8 for AMP) | Mix of -/+ | Mix of -/+ | Mix of -/+ | ||
| MET (1000 ng/mL) | Cutoff (e.g. 949.7 for MET) | Mix of -/+ | Mix of -/+ | Mix of -/+ |
The data consistently shows:
- 100% agreement (50-/0+ or 0-/50+) for samples significantly below or above the cutoff (e.g., -50% to -100% cutoff, and +50% to +100% cutoff).
- High agreement (e.g., 47-/3+ or 1-/49+) for samples at -25% and +25% of the cutoff, indicating good performance proximal to the cutoff.
- A 'mixed' result (e.g., 26-/24+ or 22-/28+) at the exact cutoff concentration. This is expected for qualitative tests designed to distinguish around a specified threshold.
Study Details:
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A table of acceptance criteria and the reported device performance: See table above.
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Sample sized used for the test set and the data provenance:
- Precision Study (Test Set): For each of the 15 drugs, studies were carried out at 9 different concentrations relative to the cutoff (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100%). For each concentration, tests were performed two runs per day for 25 days across three different lots of the device. This equates to 50 tests per concentration per lot, meaning 150 tests per concentration across all lots per drug. Given 9 concentrations and 15 drugs, the total number of qualitative tests performed in the precision study is 15 drugs * 9 concentrations * 50 tests/concentration/lot * 3 lots = 20,250 individual qualitative test results. The data provenance is not explicitly stated beyond "performed in-house", but implies controlled laboratory conditions. It is retrospective in the sense that the samples were prepared and then tested.
- Comparison Studies (Test Set): For each drug, 80 unaltered urine samples (40 negative and 40 positive) were "blind labeled" and compared to LC/MS or GC/MS results. This means 80 test samples were used for performance evaluation against ground truth for each drug. As there are 15 drugs, a total of 15 drugs * 80 samples/drug = 1200 samples were analyzed in the comparison study. The provenance for these samples is "unaltered urine samples," implying they were clinical samples, but specific country of origin or whether they were prospectively or retrospectively collected is not mentioned. Given the context of a 510(k) summary, it's typically retrospective analysis of banked samples.
- Lay-User Study:
- Configuration 1 (MOP 300): 184 males and 126 females participated. Urine samples were prepared at 8 concentrations (-100%, +/-75%, +/-25% of the cutoff). Each participant received 1 blind-labeled sample. This means 310 participants (samples) were tested for each characteristic (e.g., Cocaine detection). Given that there are multiple drugs in each configuration, and multiple concentrations per drug, the total number of tests in this section is substantial. For Methamphetamine, for example, there are 8 concentrations, implying 8 x 20 = 160 participants were given samples at specific concentrations, with 170 samples being at -50% cutoff for several drugs (potentially pooled data). It's more likely that 310 total participants each tested one device, which covers multiple drugs simultaneously in one cup. The tables presented show results for each drug at various cutoff percentages, with "Number of samples" referring to the number of individual urine samples prepared at that concentration for a given drug. For instance, for Methamphetamine, 20 samples were prepared at -100% cutoff, 20 at -75%cutoff, etc. The "170" in the "-50% Cutoff" row for several drugs is peculiar – it might indicate cumulative samples for those drugs at that specific concentration across the entire study, or a misprint.
- Configuration 2 (MOP 2000 (OPI)): 178 males and 132 females participated, similar setup.
- Data provenance for lay-user study is not stated geographically, but it's a simulated environment with prepared urine samples, likely an in-house study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Precision Study and Comparison Studies, the ground truth was established by "LC/MS or GC/MS results." These are considered highly accurate analytical methods and are the gold standard for confirming drug concentrations in urine. No human experts are explicitly mentioned for establishing ground truth for these analytical methods themselves, as they are instrumental measurements.
- For the Lay-User Study: The concentrations were confirmed by LC/MS. Again, LC/MS served as the ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For the Precision Study: No adjudication method is described; the quantitative LC/MS results serve as the definitive reference. The qualitative results (positive/negative) from the device are simply compared directly.
- For the Comparison Studies: No adjudication process is explicitly mentioned for the comparison of device results against LC/MS or GC/MS. The LC/MS or GC/MS is the definitive reference against which the device's reading is compared. Discordant results are simply listed.
- For the Lay-User Study: The "Lay person results" are the outcome of the user's interpretation of the device. These are then compared to the LC/MS confirmed concentration. No adjudication of lay-user interpretation is described.
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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 or AI assistance study was conducted or is applicable here. This device is a rapid, lateral flow immunochromatographic assay, which is a standalone point-of-care test, not an AI-assisted diagnostic tool for Human Readers. Performance is assessed on the device's output itself, or the user's interpretation of that output in the lay-user study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the Precision Study and the Comparison Studies represent "standalone" performance in a laboratory setting, where the device's output (presence/absence of a line) is objectively recorded and compared against the LC/MS/GC/MS ground truth. While human technicians operate the device and record results, the interpretation standard is purely objective based on the chemical reaction. The "discordant results" tables for the comparison studies elaborate on the instances where the device's qualitative result did not match the LC/MS/GC/MS quantitative ground truth.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The primary ground truth used for all studies (Precision, Comparison, Lay-User) is quantitative analytical results from Liquid Chromatography-Mass Spectrometry (LC/MS) or Gas Chromatography-Mass Spectrometry (GC/MS). These are highly accurate laboratory methods for identifying and quantifying substances in a sample, considered the gold standard for drug testing.
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The sample size for the training set:
- This document describes a premarket notification (510(k)) for a medical device that operates based on a well-established biochemical principle (immunochromatography). It is not an AI/ML device that requires a "training set" in the computational sense. The device itself is "trained" during its manufacturing and quality control processes to consistently react at specific cutoff concentrations. The studies described are validation studies to prove the device's performance, not to train it.
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How the ground truth for the training set was established:
- As this is not an AI/ML device, there isn't a "training set" in that context. The device's "training" refers to its design and manufacturing to react precisely to given concentrations, with the LC/MS/GC/MS as the analytical reference used during development and quality control to ensure target specificity and sensitivity.
§ 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).