(422 days)
AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine. Methadone, EDDP. Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of.
Configuration of the AssureTech DOA Dipstick Screen Panel 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.
AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine. Methadone, EDDP. Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of.
Configuration of the AssureTech 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 DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of 6-Monoacetylmorphine, 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 DOA Dipstick Screen Panel 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 provided text describes the performance characteristics of the AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests, which are in vitro diagnostic devices for detecting drugs of abuse in human urine.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are implicitly defined by the satisfactory performance in the analytical studies (precision, interference, specificity, effect of urine specific gravity and pH) and method comparison studies. The goal is for the device to correctly identify positive and negative samples, especially around the established cutoff concentrations.
A formal table of explicit acceptance criteria (e.g., minimum sensitivity/specificity percentages) is not provided directly in the text as such for "acceptance criteria." However, the reported device performance in the precision study demonstrates that the device performs as expected. For samples with drug concentrations further away from the cutoff (e.g., -100%, -75%, -50% for negative; +25%, +50%, +75%, +100% for positive), the device consistently yields the correct result (100% agreement: 30-/0+ for negative ranges and 30+/0- for positive ranges). Around the cutoff, there is some variability, which is expected for qualitative tests. For instance, at the cutoff, the positive results range from 22+/8- to 29+/1- out of 30 tests, meaning 22 to 29 out of 30 tests correctly identified as positive, and the remaining were negative. Conversely, for samples at -25% of the cutoff, all 30 tests were negative, and for samples at +25% of the cutoff, all 30 tests were positive.
For the purpose of this request, I will synthesize the implied acceptance criteria from the study design and report the performance based on the precision study across all evaluated drugs and device types, focusing on the key ranges around the cutoff.
| Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance (Consolidated from Precision Study) |
|---|---|---|
| Precision (Accuracy) | Consistent and accurate results for samples significantly below and above the cutoff concentration. Acceptable variability at the cutoff concentration. Specifically, high agreement for all samples at -50% cutoff and +50% cutoff, and a reasonable proportion of correct results at +/- 25% and at the cutoff itself (while recognizing qualitative nature). | Consistent Performance: All samples at -100%, -75%, -50% of cutoff consistently yielded negative results (30-/0+ across all drugs and lots). All samples at +25%, +50%, +75%, +100% of cutoff consistently yielded positive results (30+/0- across all drugs and lots). |
Performance at Cutoff: At the cutoff concentration, the number of positive results out of 30 varied by drug and lot, ranging from 22+/8- (e.g., COC, MDMA, THC) to 29+/1- (BZO). This indicates generally good, though not perfect, agreement with the cutoff.
Performance at -25% Cutoff: All samples at -25% of cutoff consistently yielded negative results (30-/0+ across all drugs and lots). |
| Specificity | No interference from common physiological/pathological substances or non-target drugs/metabolites at specified concentrations. | Interference: Over 100 common substances (e.g., acetaminophen, ethanol, hemoglobin, ibuprofen) showed no interference at 100ug/mL (or 1% for ethanol, 100 mg/dL for albumin).
Cross-Reactivity (6-MAM): Only 6-acetylmorphine showed 100% cross-reactivity at the cutoff. Diacetylmorphine (heroin precursor) showed 1% cross-reactivity at 1000 ng/mL, Hydromorphone and Nalorphine showed 0.2% cross-reactivity at 5000 ng/mL, and Morphine showed 0.1% at 10000 ng/mL. Most other listed substances showed 10000 ng/mL).
Cross-Reactivity (THC): 11-nor-D*-THC-9 COOH and 11-nor-D8-THC-9 COOH showed 100% cross-reactivity. Other tested cannabinoids showed 10000 ng/mL. |
| Stability | Device remains stable for a specified shelf-life under defined storage conditions. | Devices are stable at 4-30 ℃ for 24 months based on accelerated stability at 45 °C and real-time stability at 4 °C and 30 °C. |
| Effect of Urine SG/pH| Device performance should not be significantly affected by variations in urine specific gravity (SG) or pH within physiological ranges. | For urine samples with SG 1.000-1.035 and pH 4-9, results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. This indicates no significant effect. |
2. Sample Sizes and Data Provenance
- Test Set Sample Size (Precision Study): For each drug and each of the two device types (Dipstick Screen Panel and Integrated Cup), three different lots were tested. For each lot, 9 different drug concentrations (from -100% to +100% of cutoff) were evaluated. Each concentration was tested 30 times (1 run per lot per day for 10 days, across three POC sites, implying 30 tests per concentration per lot).
- Therefore, for a single drug and a single device type: 3 lots * 9 concentrations * (implied 1 test per concentration per run * 10 days * 3 sites / 3 lots) = 3 lots * 9 concentrations * 30 tests = 810 tests.
- For the two device types and 16 drugs: 2 * 16 * 810 = 25,920 individual qualitative test results (excluding controls).
- Test Set Sample Size (Method Comparison Study): For each drug (6-MAM and THC20 explicitly detailed, with a note that "the rest data were reported in the K181768"), a total of 80 unaltered clinical urine samples were tested. These 80 samples consisted of 40 negative samples and 40 positive samples. The positive samples were further categorized into "Near Cutoff Positive" (15 samples) and "High Positive" (25 samples). The negative samples were categorized into "Negative" (10 samples), "Low Negative" (20 samples), and "Near Cutoff Negative" (10 samples).
- These 80 samples were tested for each of the two device types (Dipstick Screen Panel and Integrated Cup).
- Each sample result was reviewed by 3 "Viewers" (human readers). So, for one drug and one device type, it's 80 samples * 3 viewers = 240 observations.
- Data Provenance:
- Precision Study: Samples were "prepared by spiking drug in negative samples." The text doesn't specify the origin of the "negative samples." The study was conducted in a controlled lab setting, essentially creating a prospective dataset.
- Method Comparison Study: "Unaltered clinical samples" were used. The country of origin is not explicitly stated. The study design of using "clinical samples" retrospectively analyzed against a gold standard (LC/MS) suggests these were real-world samples.
3. Number of Experts (Viewers) and Qualifications for Ground Truth in Test Set
- Ground Truth for Precision Study: The ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an analytical chemical method considered the gold standard for drug detection and quantification in urine. No human experts were involved in establishing the ground truth for this part of the study.
- Ground Truth for Method Comparison Study: The ground truth for the clinical samples was established by LC/MS.
- Human Readers (Viewers): While not establishing ground truth, the method comparison study mentions "Viewer A," "Viewer B," and "Viewer C" who ran and interpreted the tests. Their qualifications are not explicitly stated in the provided text. It's implied they were trained operators at the POC (Point of Care) testing sites.
4. Adjudication Method for the Test Set
- For the precision study, results were either positive or negative based on visual interpretation, directly compared to the known spiked concentration relative to the cutoff. No explicit adjudication method is mentioned as the results are discrete (positive/negative based on line presence at a known concentration).
- For the method comparison study, the results for each sample were recorded by "Viewer A," "Viewer B," and "Viewer C." The tables show individual viewer results, implying no formal adjudication process (like 2+1 or 3+1 consensus) was applied between the viewers. Each viewer's interpretation was directly compared against the LC/MS ground truth. Discordant results highlight instances where a viewer's reading differed from the LC/MS.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described in the provided text to assess how much human readers improve with AI vs. without AI assistance. The study evaluates the standalone performance of the rapid diagnostic device (Dipstick/Cup) and human interpretation of those devices against LC/MS, not human performance with or without AI assistance. The devices themselves are the "AI" analog (the automated detection method).
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The AssureTech DOA Dipstick Screen Panel Tests and AssureTech DOA Integrated Cup Tests are described as "competitive binding, lateral flow immunochromatographic assays." These are point-of-care devices that produce a visual result (a colored line) indicating presence or absence of a drug. While human interpretation is involved, the device itself is the "algorithm" that produces the result. The precision and specificity studies directly evaluate the performance of these devices in a controlled, standalone manner, where the output is a qualitative visual signal. The method comparison study further tests this standalone device performance with human interpretation against a golden standard.
7. Type of Ground Truth Used
- The primary ground truth used in both the precision and method comparison studies was LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate and quantitative analytical method used to confirm and quantify drug concentrations in urine samples.
8. Sample Size for the Training Set
- The provided document is a 510(k) summary for a rapid diagnostic test (lateral flow immunoassay). These types of devices are typically developed and optimized through iterative design and testing processes that involve numerous samples during the research and development phase. However, the 510(k) summary focuses on the validation studies demonstrating the device's performance for regulatory clearance. It does not explicitly describe a "training set" in the context of machine learning. The studies described are performance evaluation studies, not algorithm training studies.
9. How the Ground Truth for the Training Set Was Established
- Since a "training set" for an AI algorithm is not explicitly mentioned or relevant to the nature of these immunoassay devices, there is no information provided on how ground truth for such a set would have been established. The ground truth for the performance evaluation (test set) samples was established using LC/MS.
§ 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).