(159 days)
The 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, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:
| Drug (identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
Configurations 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 up to a maximum of 14 analytes. Only one cutoff concentration will be included per analyte per device.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized drug levels for Buprenorphine. Nortriptyline or Oxycodone in urine. 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.
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, EDDP, 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, EDDP, 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.
The Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are devices for qualitative and simultaneous detection of various drugs in human urine. The study conducted was a lay user study to verify the device's performance when used by individuals without professional training.
Here's the breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the percentage agreement with GC/MS (Gas Chromatography/Mass Spectrometry) results for different drug concentrations relative to the cutoff level. While no explicit percentage agreement threshold is stated as an "acceptance criteria", standard practice in such studies would expect high agreement for samples at or significantly away from the cutoff. The reported performance shows high agreement, particularly at concentrations of -50% Cutoff, +50% Cutoff, and +75% Cutoff.
Reported Device Performance based on Lay User Study (Agreement with GC/MS):
| Drug Category | Concentration (% of Cutoff) | Number of Samples | % Agreement (Lay Person vs. GC/MS) |
|---|---|---|---|
| For all Drugs Tested | -100% Cutoff | 20 | 100% |
| -75% Cutoff | 20 | 100% | |
| -50% Cutoff | 170 | 100% | |
| -25% Cutoff | 20 | 85-95% (varied by drug/device) | |
| +25% Cutoff | 20 | 85-95% (varied by drug/device) | |
| +50% Cutoff | 50 | 100% | |
| +75% Cutoff | 20 | 100% |
Note: The specific percentage agreement for -25% and +25% cutoff concentrations varied slightly across different drugs and device types (dip card vs. cup). For instance, Morphine at +25% Cutoff for the dip card and Oxycodone at +25% Cutoff for the cup showed 85% agreement, while others were 90-95%. Oxazepam at -25% Cutoff for the cup also showed 85% agreement.
2. Sample Sizes and Data Provenance
- Test Set Sample Size: For each drug and concentration level (e.g., Methamphetamine at -100% Cutoff), there were between 20 and 170 samples tested. Each device format (Cup and Dip Card) was tested with these samples across all drugs.
- For -100%, -75%, -25%, +25%, +75% Cutoff, there were 20 samples each.
- For -50% Cutoff, there were 170 samples.
- For +50% Cutoff, there were 50 samples.
- Total samples per drug per device format were 20+20+170+20+20+50+20 = 320 samples.
- Given there are 14 drugs, the total number of samples processed by lay users for each device format would be approximately 14 drugs * 320 samples/drug = 4480 samples.
- Data Provenance: Not explicitly stated regarding the country of origin of the data. The study was a prospective lay user study where urine samples were prepared and then tested by lay users.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable in the context of human readers for generating ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" was established by an independent laboratory method (GC/MS, see point 7).
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, this was not a MRMC comparative effectiveness study involving human readers with and without AI assistance. This study focused on the performance of a point-of-care test when interpreted by lay users.
6. Standalone Performance
- Standalone Performance: Yes, the study evaluates the standalone performance of the device (Healgen Multi-Drug Urine Test Cup and Dip Card) when used directly by lay users. The outcome of the device (positive/negative line on the test strip) as interpreted by the lay user is compared against the GC/MS reference standard.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the test set was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug concentration in urine samples.
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not mention a separate training set. The device is a lateral flow immunochromatographic assay, not an AI/ML algorithm that typically requires a training set. The "performance data of precision, cut-off, interference, specificity and method comparison" were reported in predicate device submissions (K142280, K143187, K141647, K140546, K150791, K150096 and K151348), implying these established characteristics during the development of earlier versions.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable as there is no specific "training set" for the device in the context of AI/ML or expert interpretation. The performance characteristics of the assay would have been established through a series of analytical studies using known concentrations and confirmed methods (like GC/MS) during its development and prior submissions, which serve as the foundation for the assay's expected behavior.
§ 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).