(29 days)
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone 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 |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 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 Oxazepam. Secobarbital 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 method must be used in order to obtain a confirmed analytical result. GC/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, Marijuana, Methamphetamine, Morphine, Oxycodone. Secobarbital and Methadone 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 |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 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 Oxazepam. Secobarbital 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 alternical method must be used in order to obtain a confirmed analytical result. GC/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 and Methadone (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.
Based on the provided text, the device in question is the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup, which are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of various drugs in human urine.
Here's an analysis of the acceptance criteria and the studies performed:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as a separate, quantitative table with pass/fail thresholds before presenting the results. However, the performance data presented implies the criteria for "acceptable performance" for each test type. The precision study for concentrations near the cut-off would be a key indicator for quantitative acceptance. For the qualitative tests, the performance at concentrations above and below the cutoff demonstrates the criteria.
Implied Acceptance Criteria and Reported Performance from Precision Studies (for Secobarbital)
The precision study for Secobarbital demonstrates expected performance around the cut-off (300 ng/mL). A device is expected to consistently classify samples below the cut-off as negative and above as positive. At the exact cut-off, a roughly 50/50 split is typical, reflecting the analytical variation.
| Test Parameter / Concentration (ng/mL) | Acceptance Criteria (Implied) | Reported Device Performance (CLUNGENE Multi-Drug Test Dip Card - Secobarbital) | Reported Device Performance (CLUNGENE Multi-Drug Test Easy Cup - Secobarbital) | Outcome |
|---|---|---|---|---|
| Secobarbital (Cut-off: 300 ng/mL) | ||||
| 0 (100% below) | 100% Negative | 50-/0+ (All negative across 3 lots) | 50-/0+ (All negative across 3 lots) | Pass |
| 69 (75% below) | 100% Negative | 50-/0+ (All negative across 3 lots) | 50-/0+ (All negative across 3 lots) | Pass |
| 147 (50% below) | 100% Negative | 50-/0+ (All negative across 3 lots) | 50-/0+ (All negative across 3 lots) | Pass |
| 226 (25% below) | 100% Negative | 50-/0+ (All negative across 3 lots) | 50-/0+ (All negative across 3 lots) | Pass |
| 286 (Cut-off) | Mixed results expected | Lot 1: 22-/28+, Lot 2: 26-/24+, Lot 3: 27-/23+ (Mixed positive/negative) | Lot 1: 26-/24+, Lot 2: 27-/23+, Lot 3: 21-/29+ (Mixed positive/negative) | Pass |
| 370 (25% above) | 100% Positive | 50+/0- (All positive across 3 lots) | 50+/0- (All positive across 3 lots) | Pass |
| 457 (50% above) | 100% Positive | 50+/0- (All positive across 3 lots) | 50+/0- (All positive across 3 lots) | Pass |
| 510 (75% above) | 100% Positive | 50+/0- (All positive across 3 lots) | 50+/0- (All positive across 3 lots) | Pass |
| 559 (100% above) | 100% Positive | 50+/0- (All positive across 3 lots) | 50+/0- (All positive across 3 lots) | Pass |
Similar tables and outcomes are provided for Methadone and Oxycodone, and referenced for other drugs (Amphetamine, Oxazepam, Cocaine, Methamphetamine, Morphine, Marijuana) in previous submissions (K153741 and K161251).
Lay-User Study Performance:
The lay-user study also demonstrates adherence to an implicit acceptance criterion that a high percentage of correct results should be obtained, especially for samples significantly above or below the cutoff. For samples at +/- 25% of the cutoff, a slight reduction in accuracy is observed and expected due to the nature of qualitative assays at the analytical threshold.
| Drug | % of Cut-off | Expected Outcome | Reported % of Correct Results | Outcome |
|---|---|---|---|---|
| AMP | -100% to -50% | 100% Negative | 100% | Pass |
| -25% | High % Negative | 95% Negative | Pass | |
| +25% | High % Positive | 95% Positive | Pass | |
| +50% to +75% | 100% Positive | 100% | Pass | |
| BAR, COC, BZO, MTD, MOP, OXY, THC (similar patterns across drugs) | -100% to -50% | 100% Negative | Mostly 100% | Pass |
| -25% | High % Negative | 90-100% | Pass | |
| +25% | High % Positive | 90-100% | Pass | |
| +50% to +75% | 100% Positive | 100% | Pass |
2. Sample size used for the test set and the data provenance
-
Precision Study:
- Sample Size: For each drug and concentration, "tests were performed two runs per day for 25 days per device," which equates to 50 individual tests per concentration per lot. With 9 concentrations tested and 3 lots, this is 50 * 9 * 3 = 1350 tests per drug type. This study was carried out for Secobarbital, Methadone, and Oxycodone. Data for other drugs were reported previously.
- Data Provenance: Samples were "prepared by spiking drug in negative urine samples." This indicates controlled laboratory conditions. The text does not specify the country of origin of the urine samples themselves, but the manufacturer is Hangzhou Clongene Biotech Co.,Ltd. in China. The study is prospective in the sense that samples were prepared and then tested.
-
Comparison Studies (Clinical Samples):
- Sample Size: "Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug." This was done for Secobarbital, Methadone, and Oxycodone. Similar studies for the other drugs were referenced in previous submissions.
- Data Provenance: "unaltered clinical samples." The origin (e.g., country) is not specified. The study design sounds retrospective, as samples were collected clinically and then processed for the study.
-
Lay-user Study:
- Sample Size: "A lay user study was performed at three intended user sites with 300 lay persons for each device format." Each participant tested one sample. The samples included negative and various levels around the cut-off. For each drug, the total number of samples tested with the device by lay users corresponds to the sum of samples across all concentrations (e.g., for AMP, 20+20+160+20+20+40+20 = 300 samples). This implies 300 samples per drug per device format. Given there are 9 drugs, this means 300 * 9 tests per device format.
- Data Provenance: Urine samples were "prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." This indicates controlled laboratory-prepared samples. The study was prospective in its execution. The "three intended user sites" are not specified geographically.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Precision Study: The ground truth for the prepared samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate analytical method, and no human experts are noted for establishing this specific ground truth.
- Comparison Studies (Clinical Samples): The ground truth for the clinical samples was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is explicitly stated as "The samples were blind labeled and compared to GC/MS results." No human experts are mentioned for establishing the ground truth, as GC/MS is an objective chemical analysis method.
- Lay-user Study: The ground truth for the prepared samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry). No human experts are noted for establishing this specific ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For the device's reading: In the comparison studies, "three laboratory assistants" for each device (Dip Card and Easy Cup) seem to have visually read the results. The document provides tables breaking down positive/negative calls by "Viewer A, Viewer B, Viewer C". There is no explicit mention of an adjudication process (like 2+1 or 3+1) if these viewers disagreed. The data shows individual viewer results, and discordant results are listed separately, implying that their individual interpretations were recorded.
- For the ground truth: As the ground truth for all studies was established by chemical analytical methods (LC/MS or GC/MS), no human adjudication method was needed for the ground truth itself.
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, an MRMC comparative effectiveness study was not performed in the context of AI assistance. This document describes the performance of a point-of-care, visually interpreted immunochromatographic device (dip card/easy cup drug test). The "viewers" are laboratory assistants reading the visual results, not radiologists interpreting medical images with or without AI.
- The study is a direct comparison of the device's results against a gold standard (GC/MS or LC/MS), and a lay-user study to assess comprehensibility and ease of use. There is no AI component or human-in-the-loop AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a lateral flow immunoassay that produces a visual result inherently requiring human interpretation (either by a lay user or laboratory assistant). There is no "algorithm" in the sense of software interpreting results without human input described for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for all studies (Precision, Comparison, Lay-user) was established using objective chemical analytical methods: LC/MS and GC/MS. These are considered gold standards for drug concentration determination. No expert consensus, pathology, or outcomes data were used as ground truth for this type of diagnostic device.
8. The sample size for the training set
- This information is not provided in the document. The document describes performance testing of the final device, not the development or training of a software algorithm. For an immunochromatographic assay, the "training set" would refer to the samples used during the assay development and optimization phase to establish the device's characteristics (e.g., antibody selection, membrane properties, cutoff optimization), which is distinct from the formal performance validation studies presented here.
9. How the ground truth for the training set was established
- This information is not provided in the document, as it pertains to the device's development phase rather than its validation. However, it can be inferred that similar analytical methods (LC/MS/GC/MS) would have been used during development to characterize drug concentrations in samples used for internal optimization.
§ 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).