(139 days)
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off level |
|---|---|---|
| Barbiturates (BAR) | Secobarbital | 300 ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
| Methylenedioxymethampheta | ||
| mine (MDMA) | 3,4-Methylenedioxymetha | |
| mphetamine | 500 ng/mL | |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.
This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Barbiturates, Benzodiazepines, Methylenedioxymethamine, Methadone, Oxycodone, Phencyclidine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.
The provided document describes the Co-Innovation Biotech Co.,Ltd. One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard for qualitative detection of drugs of abuse in human urine. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for qualitative immunoassay tests like these are typically assessed by comparing the device's results (positive/negative) against a gold standard (GC/MS) especially around the cutoff concentration. While explicit numerical acceptance criteria (e.g., % agreement, sensitivity, specificity targets) are not explicitly stated as 'acceptance criteria' in the document, the performance data implicitly serves as the demonstration that the device performs acceptably. The study evaluates the device's ability to correctly identify drug-free, less than half cutoff, near cutoff negative, near cutoff positive, and high positive samples.
The tables below synthesize the reported device performance for both the Test Cup and Test Dipcard formats for single and multi-drug tests, against the GC/MS analysis. The "Total" column in the original tables sums up the sample distribution across concentration categories, not the total number of samples processed for each drug test condition. The key performance indicator here is the consistency of results, particularly for samples around the cutoff concentration.
Device Performance for One Step Single/Multi-drug Test Cup & Dipcard (Single Drug Test Example - All Drugs follow similar pattern)
| Drug Test | Co-Innovation Result | GC/MS Analysis (Drug-free) | GC/MS Analysis (1.5x Cutoff) | Total Samples |
|---|---|---|---|---|---|---|---|
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 0 | 7 | 0 | 0 | 80 |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| | - | 31 | 0 | 8 | 0 | 0 | 80 |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| | - | 32 | 3 | 5 | 1 | 0 | 80 |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 32 | 2 | 5 | 0 | 0 | 80 |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 35 | 0 | 5 | 0 | 0 | 80 |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 35 | 0 | 4 | 0 | 0 | 80 |
Analysis of Discordant Results (Example for Test Cup and Dipcard, Single and Multi-drug)
| Drug Test | Cutoff (ng/mL) | Device Result | GC/MS Drug Concentration (ng/mL) | Drug in Urine |
|---|---|---|---|---|
| BZO | 300 | Positive | 188 | Oxazepam |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxymethamphetamine |
| MTD | 300 | Positive | 209 | Methadone |
| PCP | 25 | Positive | 23 | Phencyclidine |
| (Note: These discordant results are consistent across all four tables presented for Single Drug Test Cup, Single Drug Test Dipcard, Multi-drug Test Cup, and Multi-drug Test Dipcard) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 80 clinical urine specimens were used for each drug tested, for each device format (Single Drug Test Cup, Single Drug Test Dipcard, Multi-drug Test Cup, Multi-drug Test Dipcard). Therefore, for each drug, a total of 320 samples were analyzed (80 * 4). The samples were categorized into five groups based on concentration relative to the cutoff (drug-free, less than half the cutoff negative, near cutoff negative, near cutoff positive, and high positive).
- Data Provenance: The data is from "clinical urine specimens," implying human origin. However, the country of origin is not specified, and it is a retrospective analysis as the specimens were analyzed by GC/MS for comparison with the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered the "preferred confirmatory method" for drug of abuse testing.
- No human "experts" are mentioned as having established the ground truth through consensus or individual reading of the device results for the purpose of the primary accuracy study. The device results were compared directly against the GC/MS findings.
4. Adjudication Method for the Test Set
- None in the traditional sense of multiple human readers adjudicating results. The device's qualitative results (positive/negative) were directly compared to the quantitative GC/MS results for each sample. Discordant results were individually listed with the GC/MS concentration.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not performed. The study's focus was on the standalone performance of the devices against a gold standard (GC/MS). Human readers' improvement with or without AI assistance is not relevant here as it's a diagnostic test that provides a clear positive/negative result, not an AI-assisted diagnostic imaging interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this was a standalone performance study. The "One Step Single/Multi-drug Test Cup" and "One Step Single/Multi-drug Test Dipcard" are qualitative, lateral flow immunochromatographic assays designed to be read directly without an instrument or human interpretation loop beyond reading the presence or absence of test lines. The performance data presented directly reflects the device's output (positive/negative) compared to GC/MS.
7. The Type of Ground Truth Used
- The ground truth used was quantitative analytical data from Gas Chromatography/Mass Spectrometry (GC/MS), which is the preferred confirmatory method for drug of abuse testing. This is a highly objective and precise method for determining drug concentration.
8. The Sample Size for the Training Set
- This document describes a performance evaluation of a medical device, not an AI algorithm that requires a training set. Therefore, no training set for an algorithm is mentioned or applicable in this context. The devices are immunoassay tests, not machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, there is no training set for an algorithm as the device is an immunoassay test.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).