(169 days)
The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid chromatographic immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff |
|---|---|---|---|
| Concentration | |||
| Amphetamine | AMP | d-Amphetamine | 1000 ng/ml |
| Cocaine | COC | Benzoylecgonine | 300 ng/ml |
| Marijuana | THC | 11-nor- $\Delta^9$ -THC9-COOH | 50 ng/ml |
| Methamphetamine | MET | d-Methamphetamine | 1000 ng/ml |
| Opiates | OPI/MOR | Morphine | 300 ng/ml |
| Phencyclidine | PCP | Phencyclidine | 25 ng/ml |
The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card are intended for qualitative detection of drugs of abuse for health care professionals, in vitro diagnostic use and prescription use ONLY. It is not intended for point-of-care settings or over the counter use.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods.
Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
Chemtrue® Single / Multi-panel Drug Screen Cassette and Dip Card tests are one-step, lateral flow, colloidal gold based chromatographic immunoassays for the rapid, qualitative detection of Amphetamine, Methamphetamine, Marijuana (THC), Phencyclidine, Cocaine and Opiates (Morphine) 300 in human urine. It is intended for Professional /Prescription Use ONLY.
This assay provides a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory result. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Here's a breakdown of the acceptance criteria and the study details for the Chemtrue® Single/Multi-panel Drug Screen Tests, extracted from the provided text:
Acceptance Criteria and Device Performance
| Test Analyte | Cut-off (ng/ml) | Acceptance Criteria (from predicate kit reference) | Reported Device Performance (Overall Agreement with GC/MS) |
|---|---|---|---|
| Amphetamine | 1000 | >90% Analytical Accuracy (from predicate kit) | 99.1% |
| Cocaine | 300 | >90% Analytical Accuracy (from predicate kit) | 100% |
| Opiates | 300 | >90% Analytical Accuracy (from predicate kit) | 98.3% |
| Methamphetamine | 1000 | >90% Analytical Accuracy (from predicate kit) | 98.1% |
| Phencyclidine | 25 | >90% Analytical Accuracy (from predicate kit) | 100% |
| Marijuana (THC) | 50 | >90% Analytical Accuracy (from predicate kit) | 100% |
Note on Acceptance Criteria: The document explicitly states: "Chemtron Biotech, Inc. has reviewed the requirements of Section 514 of the Act, which states that to date no performance standards has been established for drug screen test systems by the FDA." The acceptance criteria are inferred from the predicate device's reported accuracy of ">90%" and the general claim of substantial equivalence. The overall performance goal for the clinical specimen correlation study was "> 98% total correlation when compared to the GC/MS methodology."
Study Details
1. Sample size used for the test set and the data provenance:
- Test Set (Clinical Specimen Correlation Study):
- Total Samples: 673 clinical specimens.
- Per Analyte Breakdown (from Table 1):
- AMP: 114
- COC: 115
- OPI(MOR)300: 119
- MET: 106
- PCP: 114
- THC: 106
- Provenance: "Clinical specimens." The country of origin is not specified, but the submission is to the US FDA, implying relevance to a US context or similar regulatory standards. The study is retrospective, as it used "blind-labeled clinical specimen correlation study" with "confirmed GC/MS values" already established.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), not by human expert interpretation of the test device itself. GC/MS is a laboratory analytical method.
3. Adjudication method for the test set:
- Not applicable, as the ground truth was established by GC/MS, which is a definitive analytical method, not requiring adjudication of subjective interpretations.
4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool that requires human reader improvement assessment.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance study was done. The "accuracy (Method comparison) study" directly compared the Chemtrue® device's results to GC/MS values, without human-in-the-loop assistance for interpretation. The test device itself provides a visual result (colored lines) which is then interpreted by a human, but the study focused on the device's analytical accuracy against the gold standard.
6. The type of ground truth used:
- Pathology/Outcomes Data: The primary ground truth for the accuracy study was Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). These are described as "the preferred confirmatory methods" and "specific alternative chemical method[s]". The study states it evaluated performance "with the confirmed GC/MS values".
7. The sample size for the training set:
- Not explicitly stated for a "training set." This type of in-vitro diagnostic device (immunoassay) is not typically "trained" in the same way a machine learning algorithm is. The device's performance is based on its chemical and biological design.
- However, various other studies were conducted on the device's inherent characteristics:
- Analytical Sensitivity Study Data: 180 samples per control level (0, -50%, -25%, Cut-off, +25%, +50% of cut-off), totaling 1080 samples for each drug assay's sensitivity testing.
- Analytical Precision Study Data (Reproducibility): For each drug (AMP, COC, MAMP, OPI, PCP, THC), 30 samples were tested per control level (Negative, -50%, -25%, Cut-off, +25%, +50% of cut-off) across three operators and three batches for 10 days, accumulating significant data for reproducibility.
- Analytical Specificity Study: Data summarized in a section, implying tests with various interfering substances/cross-reactants.
- Stability Study: Three lots of each product format (Dip Card and Cassette) were included.
8. How the ground truth for the training set was established:
- Again, the concept of a "training set" doesn't directly apply here. For the various analytical performance studies (sensitivity, precision, specificity), the "ground truth" or reference values were established using commercial urine controls that were "GC/MS confirmed" and "blind coded". This implies that external, verified standards were used to assess the device's performance under controlled conditions.
§ 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).