(216 days)
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Propoxyphene | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine 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. GC/MS or LC/MS is the preferred confirmatory method.
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Propoxyphene, Nortriptyline and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips.
A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Propoxyphene, Nortriptyline and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each drug for the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card in the lay user study can be inferred as achieving at least 85% agreement with GC/MS results for urine samples near the cutoff concentrations (+/- 25% of cutoff). For samples further away from the cutoff (±50%, ±75%, -100% of cutoff), the acceptance criterion appears to be 100% agreement.
Healgen Multi-Drug Urine Test Cup and Dip Card Performance (Lay User Study Data)
| Drug | % of Cutoff | Number of Samples | % Agreement (Lay Person vs. GC/MS) |
|---|---|---|---|
| Methamphetamine | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Cocaine | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Cannabinoids (THC) | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 90% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Morphine (MOP 300) | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 85% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Morphine (MOP 2000) | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Oxazepam | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 85% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Amphetamine | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 90% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Oxycodone | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 90% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Methadone | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 85% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Secobarbital | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Buprenorphine | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Phencyclidine | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 90% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| MDMA | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Propoxyphene | -100% | 20 | 100% |
| -75% | 20 | 100% | |
| -50% | 160 | 100% | |
| -25% | 20 | 90% | |
| +25% | 20 | 90% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% | |
| Tricyclic Antidepressants | -100% | 20 | 100% |
| (Nortriptyline) | -75% | 20 | 100% |
| -50% | 160 | 100% | |
| -25% | 20 | 95% | |
| +25% | 20 | 95% | |
| +50% | 40 | 100% | |
| +75% | 20 | 100% |
The device meets these acceptance criteria, as all reported percentage agreements are at or above the specified thresholds for each drug and concentration level.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For each drug analyte tested in the lay user study, the total number of samples evaluated was 300 per format (Cup and Dip Card) across different concentration levels.
- Specifically, for each drug analyte, the breakdown of samples by concentration was:
- -100% Cutoff: 20 samples
- -75% Cutoff: 20 samples
- -50% Cutoff: 160 samples
- -25% Cutoff: 20 samples
- +25% Cutoff: 20 samples
- +50% Cutoff: 40 samples
- +75% Cutoff: 20 samples
- Data Provenance: The document does not explicitly state the country of origin of the data. However, as it is a submission to the United States FDA, it is implied that the data is intended for use in the US market. The study utilized "drug free-pooled urine specimens" which were then spiked with drugs, indicating a controlled laboratory setting for sample preparation. The study was conducted at "three intended user sites" with "lay persons," suggesting a prospective evaluation of the device by untrained users.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable in the context of this study. The ground truth was not established by human experts interpreting results from the device itself.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an objective chemical analysis method, not a subjective interpretation requiring adjudication among experts. The lay users independently read the results from the test devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This study focuses on the agreement of the device's results (read by lay users) with a gold standard (GC/MS), rather than comparing the performance of human readers with and without AI assistance. The device itself is a lateral flow immunoassay, not an AI system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone study was done in the sense that the device's performance was compared directly against a definitive analytical method (GC/MS). The lay user study involved individuals interpreting the results of the device directly, without the intervention of an algorithm or AI to assist in that interpretation. The comparison is between the human interpretation of the device and the chemical gold standard, effectively evaluating the standalone performance of the rapid immunoassay device.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "The concentrations of the samples were confirmed by GC/MS." GC/MS is a highly accurate and widely accepted method for confirming the presence and concentration of drugs in urine, thus serving as the gold standard.
8. The Sample Size for the Training Set
- The document does not explicitly mention a training set in the context of the lay user study or the development of this specific final product (Healgen Multi-Drug Urine Test Cup/Dip Card). The performance data cited (precision, cut-off, interference, specificity, and method comparison) refers to earlier, individual FDA-cleared predicate devices (K142280, K143187, etc.). It's possible that earlier development and validation work for those predicate devices constituted a "training" or development phase, but details are not provided here. This document primarily describes the validation of the multi-drug format for lay use against a gold standard.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly described for this submission, the method for establishing its ground truth is not provided. However, for similar in-vitro diagnostic devices, the ground truth for training/development (if applicable) would typically be established using validated laboratory reference methods such as GC/MS or LC/MS, similar to the method used for the test set.
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).