(28 days)
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Opiates | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | D,L-Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 ng/mL |
| Propoxyphene | d-Propoxyphene | 300 ng/mL |
Configuration of the CLUNGENE® Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, 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. GCMS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Opiates | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | D,L-Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 ng/mL |
| Propoxyphene | d-Propoxyphene | 300 ng/mL |
Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, 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 CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The CLUNGENE Multi-Drug Test Dip Card kit contains a Dip Card device, a package insert and a urine cup for sample collection. The CLUNGENE Multi-Drug Test Easy Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as a single, consolidated table with pass/fail metrics. However, the "Performance Characteristics" section details various studies with implied performance targets. The key performance demonstrated is in the precision studies and lay-user studies for detecting drug analytes in urine at specific cut-off levels.
Implied Acceptance Criteria (based on presented data patterns):
| Test | Acceptance Criteria (implied from data) | Reported Device Performance |
|---|---|---|
| Precision (EDDP, Opiates, Propoxyphene) - Dip Card & Easy Cup | All samples at -100%, -75%, -50%, -25% Cut-off should be Negative. | |
| All samples at +25%, +50%, +75%, +100% Cut-off should be Positive. | ||
| Samples at Cut-off should show a mix of positive and negative results, indicating accurate determination around the cutoff. | Met: For all three analytes and both device types, samples at -100% to -25% Cut-off were 100% negative (50-/0+ for each lot). Samples at +25% to +100% Cut-off were 100% positive (50+/0- for each lot). | |
| At the Cut-off concentration, results were mixed (e.g., Dip Card EDDP Lot 1: 27-/23+), demonstrating ability to differentiate around the cutoff. | ||
| Interference | No interference at a concentration of 100 µg/mL for listed compounds. | Met: No differences observed between device types; comprehensive list of non-interfering compounds provided (e.g., Acetaminophen, Aspirin, Albumin, Hemoglobin). |
| Specificity (Cross-Reactivity) | List of compounds and their cross-reactivity percentages. Implied: High specificity for the target analyte (100% at cutoff), quantifiable cross-reactivity for structurally related compounds. | Met: High specificity shown for target analytes (e.g., EDDP 100% at 300 ng/mL, Morphine 100% at 2000 ng/mL, d-Propoxyphene 100% at 300 ng/mL). Cross-reactivity for related compounds is quantified at higher concentrations (e.g., Disopyramide 0.4% for EDDP, Thebaine 10% for Opiate). |
| Effect of Urine Specific Gravity and pH | All samples at or above +25% Cut-Off should be Positive. | |
| All samples at or below -25% Cut-Off should be Negative. | Met: "Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off." No differences observed between device types. | |
| Lay-User Study (Overall Performance) | High percentage of correct results across all drug analytes and concentration levels. Instructions easily followed. | Met: The table for the lay-user study shows high percentages of correct results across all drugs and concentration levels, frequently 100% for clear negatives and positives, and 95% for those near the +/-25% cutoff. All lay users indicated that instructions were easily followed. |
| Lay-User Study (Reading Level) | Reading Grade Level should be appropriate for lay users. | Met: Flesch-Kincaid reading analysis showed a Grade Level of 7, which is generally considered appropriate for a broad lay audience. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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Test Set Sample Size:
- Precision Studies: For EDDP, Opiates, and Propoxyphene, each concentration level (-100% to +100% cut-off) was tested with 50 samples for each of three lots, making a total of 450 tests per analyte per lot (50 samples * 9 concentrations) * 3 lots = 1350 tests per analyte. Since there are three analytes and two device types (Dip Card and Easy Cup), this would be 1350 tests * 3 analytes * 2 devices = 8100 individual tests for these three new analytes in the precision study.
- Method Comparison Studies: For EDDP, Opiates, and Propoxyphene, 80 unaltered clinical samples (40 negative and 40 positive) were used for each drug. This means 80 samples * 3 drugs * 2 device types = 480 samples.
- Lay-user Study: 310 lay persons were involved for each device format (Dip Card and Easy Cup). The total number of individual tests performed by lay users is not explicitly stated as a single number but would be 310 tests * 15 analytes * 2 device formats = 9300 tests (based on the "entire panel" evaluation). For each drug, a varying number of samples were prepared across different concentration levels, totaling 360 samples for Amphetamine, for example.
- Interference and Specificity Studies: Samples were "spiked into negative urine" and tested using three lots of each device. Numerical sample sizes are not provided for these, but rather the list of compounds and their effects.
- Effect of Urine Specific Gravity and pH: Urine samples were spiked with drugs at +/-25% Cut-Off levels and tested using three lots of each device. Numerical sample sizes are not provided.
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Data Provenance: The document does not explicitly state the country of origin of the data for the experimental studies. However, the submitter, Hangzhou Clongene Biotech Co.,Ltd., is located in China, which might suggest the studies were conducted there. The clinical samples for the method comparison were "unaltered clinical samples." The lay-user study was performed "at three intended user sites."
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Retrospective or Prospective: Not explicitly stated, but the precision, interference, specificity, and pH/specific gravity studies appear to be prospective, controlled laboratory studies. The method comparison using "unaltered clinical samples" suggests a prospective collection or at least a retrospective analysis of prospectively collected samples with LC/MS confirmation. The lay-user study appears to be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: For the method comparison studies, the "in-house" tests were performed by "three laboratory assistants for each device." Their qualifications are not specified beyond being "laboratory assistants."
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The ground truth for the test set for the method comparison studies was established by LC/MS results, not by human expert adjudication of the device results themselves. The "Viewer" results (Viewer A, B, C) in the method comparison tables refer to the readings by the three laboratory assistants using the multi-drug test devices, which were then compared against the LC/MS ground truth.
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
- A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not explicitly stated as being performed in the context of comparing human readers with and without AI assistance.
- The document describes a "Comparison Studies" section comparing the device's performance to LC/MS results, with three "viewers" (laboratory assistants) reading the device results. This is a form of multi-reader study, but it is a standalone performance assessment against a gold standard (LC/MS), not a comparative effectiveness study of human readers with and without AI.
- Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The devices (CLUNGENE Multi-Drug Test Dip Card and Easy Cup) are described as "competitive binding, lateral flow immunochromatographic assay" and are read visually. These are not AI-driven devices, and their performance inherently involves "human-in-the-loop" visual interpretation.
- Therefore, a standalone (algorithm only) performance study was not done, as the device itself is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for all performance studies (e.g., Precision, Specificity, Method Comparison, Lay-user study) was established using Liquid Chromatography-Mass Spectrometry (LC/MS). For the precision study, samples were "prepared by spiking drug in negative urine samples" and "confirmed by LC/MS." For the method comparison study, "unaltered clinical samples" were "compared to LC/MS results."
8. The sample size for the training set
- This information is not applicable. The CLUNGENE devices are immunoassay-based test kits, not machine learning or AI algorithms that require a "training set" in the computational sense. The "training" for the device refers to its manufacturing and validation processes, not data-driven algorithmic training.
9. How the ground truth for the training set was established
- This information is not applicable as the device is not an AI/ML algorithm requiring a training set.
§ 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).