(51 days)
The CLUNGENE Multi-Drug Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:
| Drug | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Morphine (MOP/OPI300) | Morphine | 300 |
| Morphine (MOP/OPI2000) | Morphine | 2,000 |
| Methamphetamine (mAMP/MET1000) | D-Methamphetamine | 1,000 |
| Methamphetamine (mAMP/MET500) | D-Methamphetamine | 500 |
| Cocaine (COC300) | Benzoylecgonine | 300 |
| Cocaine (COC150) | Benzoylecgonine | 150 |
| Marijuana (THC) | 11-nor-9-THC-9-COOH | 50 |
| Methylenedioxymethamphetamine (MDMA) | D,L-Methylenedioxymethamphetamine | 500 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Propoxyphene (PPX) | D-Propoxyphene | 300 |
| Amphetamine (AMP1000) | D-Amphetamine | 1,000 |
| Amphetamine (AMP500) | D-Amphetamine | 500 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Methadone metabolite (EDDP) | 2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Oxazepam (BZO) | Oxazepam | 300 |
| Nortriptyline (TCA) | Nortriptyline | 1,000 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Methadone (MTD) | Methadone | 300 |
| 6-Monoacetylmorphine (6-MAM) | 6-Monoacetylmorphine | 10 |
| Fentanyl (FYL) | Fentanyl | 1 |
The single or multi-test cups can consist of any combination of the above listed drug analytes, but only one cut off concentration under same drug condition will be included per device.
This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
The CLUNGENE Multi-Drug Home Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:
| Drug (Identifier) | Cut-off (ng/mL) |
|---|---|
| Morphine (MOP/OPI2000) | 300 or 2000 |
| Methamphetamine (mAMP/MET) | 500 or 1,000 |
| Cocaine (COC) | 150 or 300 |
| Marijuana (THC) | 50 |
| Methylenedioxymethamphetamine (MDMA) | 500 |
| Buprenorphine (BUP) | 10 |
| Propoxyphene (PPX) | 300 |
| Amphetamine (AMP) | 500 or 1,000 |
| Phencyclidine (PCP) | 25 |
| Methadone metabolite (EDDP) | 300 |
| Oxycodone (OXY) | 100 |
| Oxazepam (BZO) | 300 |
| Nortriptyline (TCA) | 1,000 |
| Secobarbital (BAR) | 300 |
| Methadone (MTD) | 300 |
| 6-Monoacetylmorphine (6-MAM) | 10 |
| Fentanyl (FYL) | 1 |
| The single or multi-test cup offers any combination from above 1 to 17 drugs, but only one cut off concentration under same drug condition will be included per device. |
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC-MS/MS is the preferred confirmatory method.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
This document provides details on the performance characteristics of the CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup. Since this is an in vitro diagnostic device (specifically, a drug screening test), the acceptance criteria and study design are typically focused on analytical performance (accuracy, precision, analytical specificity) rather than a multi-reader multi-case (MRMC) comparative effectiveness study, which is more common for imaging AI. Similarly, "human readers improving with AI vs without AI" is not applicable here as the device is the test, not an aid to human interpretation of another modality.
Here's the breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for qualitative drug screening tests like this is accurate detection around a specific cutoff concentration. The reported performance demonstrates the device's ability to correctly classify samples as positive or negative relative to these cutoffs.
Table of Acceptance Criteria and Reported Device Performance (Analytical Precision/Reproducibility)
The "Acceptance Criteria" column represents the desired performance for a qualitative assay around its cutoff. For positive results, this means detecting drug concentrations above the cutoff, and for negative results, it means not detecting concentrations below the cutoff. The provided precision data shows the number of positive (+) and negative (-) results out of 50 tests for various concentrations relative to the cutoff. An ideal performance would show 100% positive for concentrations above cutoff and 100% negative for concentrations below, with roughly 50/50 split at the cutoff itself (due to inherent variability).
| Drug (Cut-off ng/mL) | Acceptance Criteria (Implicit for qualitative assay) | Reported Device Performance (Accuracy as evidenced by reproducibility at various concentrations) Number of negative/positive results out of 50 tests. Values are aggregated across 3 lots where available. |
|---|---|---|
| MOP300 | All samples >cutoff should test positive; all samples |
§ 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).