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510(k) Data Aggregation
(161 days)
'RapidTec'-5M-Multiple Drug Test is used for the qualitative detection of the following abused substances in human urine: methamphetamines, benzoyl ecgonine, phencyclidine, opiates and cannabinoids. This immunoassay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS.)
'RapidTec'-5M-Multiple Dip Test is a onc-step lateral flow immunoassay for the simultaneous qualitative detection of methamphetamines, benzoyl ecgonine, cannabinoids, phencyclidine, and opiates in urine.
The assays employed in the 'RapidTec'-5M-Multiple Dip Test is based on the same principle of highly specific reactions between antigens and antibodies.
This assay is a one-step, competitive, immunoassay for the detection of marijuana, opiates, phencyclidine, cocaine and methamphetamine in human urine. The test device consists of a membrane strip onto which drug conjugates have been immobilized and a colloidal gold-multi-antibody complex dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area.
When drug is present in the urine sample, the drug or metabolite will compete with its corresponding drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result.
A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions.
A negative urine will produce six colored bands, and a positive sample will produce only one band.
The provided text describes the 'RapidTec'-5M-Multiple Dip Test, an immunoassay for detecting various drugs in human urine. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the stated cut-off concentrations for each drug. The device is expected to detect drugs at or above these levels. The performance (reproducibility) was evaluated against these criteria.
| Drug Constituent | Acceptance Criteria (Cut-off Concentration) | Reported Device Performance (Detection at or above concentration) |
|---|---|---|
| Methamphetamine | 1000 ng/ml | Reproducibility confirmed at 1000 ng/ml |
| Benzoyl ecgonine | 300 ng/ml | Reproducibility confirmed at 300 ng/ml |
| Cannabinoids | 50 ng/ml | Reproducibility confirmed at 50 ng/ml |
| Phencyclidine | 25 ng/ml | Reproducibility confirmed at 25 ng/ml |
| Opiates | 2000 ng/ml | Reproducibility confirmed at 2000 ng/ml |
| Opiates | 300 ng/ml | Reproducibility confirmed at 300 ng/ml |
| (Note: Opiates have two listed detection levels in the 'Performance Characteristics' section, which could indicate different specific opiates or varying sensitivity levels within the opiate class. For the purpose of this table, both are included as reported performance.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the reproducibility study, each sample (control urines containing concentrations above and below the cut-off, as well as negative controls) was tested four times, twice daily, for five days. The total number of individual samples or unique urine specimens is not explicitly stated.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The text does not mention the use of experts to establish ground truth for the test set.
4. Adjudication Method for the Test Set
- Not applicable, as expert adjudication is not mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned. The study described focuses on device reproducibility rather than human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, the study described is a standalone performance study. The device's reproducibility in detecting drug metabolites at specified cut-off levels was evaluated independently.
7. Type of Ground Truth Used
- GC/MS (Gas Chromatography/Mass Spectrometry): The concentrations of drugs in the control urines were "verified by GC/MS." This indicates that GC/MS was used as the reference standard or "ground truth" to confirm the actual drug levels in the samples used for testing the device's reproducibility.
8. Sample Size for the Training Set
- The document describes performance testing of a device, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an algorithm. The ground truth for the test samples was established using GC/MS (as mentioned in point 7).
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