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510(k) Data Aggregation
(75 days)
This device is intended for professional medical/forensic screening of urine for Methamphetamine.
The trade name of the device is One Step™ Urine Drug of Abuse Methamphetamine Test having a designated common name of Methamphetamine Test System and a classification as a class II device per 21 CFR ¶ 862.3610. TCPI's One Step™ Urine Drug of Abuse Methamphetamine Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 500 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
The provided text describes a 510k submission for the "One Step™ URINE DRUG OF ABUSE METHAMPHETAMINE TEST" by Technical Chemicals & Products, Inc. This device is intended for qualitative testing of urine for Methamphetamine and its metabolites.
Here's an analysis of the acceptance criteria and study proving device performance based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined quantitative acceptance criteria (e.g., "sensitivity must be >X%"). Instead, it presents the device's performance metrics from a clinical trial and initial testing. We can infer the implied acceptance criteria from the reported performance, suggesting that the achieved values were deemed acceptable.
| Metric | Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|---|
| Relative Sensitivity | High (e.g., 1.00) | 1.00 | Reported during initial testing against Sigma SIA™ on GC/MS-confirmed positive samples. |
| Relative Specificity | High (e.g., 1.00) | 1.00 | Reported during initial testing against Sigma SIA™ on GC/MS-confirmed positive samples. |
| Concordance (Initial) | High (e.g., 100%) | 100% | Reported during initial testing against Sigma SIA™ on GC/MS-confirmed positive samples. |
| Agreement (Positive Samples - Clinical Trial) | High (e.g., 1.00) | 1.00 | Agreement with GC/MS for positive samples in the clinical trial alone. |
| Agreement (Negative Samples - Clinical Trial) | High (e.g., 0.907 or higher) | 0.907 | Agreement with GC/MS for negative samples in the clinical trial alone. |
| Accuracy (Clinical Trial) | High (e.g., 94.67% or higher) | 94.67% | Overall accuracy for the clinical trial alone. |
| Agreement (Positive Samples - Combined Data) | High (e.g., 1.00) | 1.00 | Agreement with GC/MS for positive samples when initial and clinical trial data are combined. |
| Agreement (Negative Samples - Combined Data) | High (e.g., 0.948 or higher) | 0.948 | Agreement with GC/MS for negative samples when initial and clinical trial data are combined. This value "rose to 0.948" compared to the clinical trial alone, suggesting the combined larger dataset yielded a more representative specificity. |
| Concordance (Combined Data) | High (e.g., 97.24% or higher) | 97.24% | Overall concordance when initial and clinical trial data are combined. |
| False Positives | Acknowledged | Yes (Ephedrine, PPA) | The device reports false positives when ephedrine and phenylpropanolamine (PPA) are present. This is acknowledged as a characteristic "like all of the screening methods tested." |
| Detection Level | 500 ng/ml | 500 ng/ml | The device is designed for a detection level of 500 ng/ml. This is an inherent design specification rather than a performance metric. |
2. Sample sizes used for the test set and the data provenance
- Initial Testing: The sample size for the initial testing is not explicitly stated. It refers to "samples documented to be positive by GC/MS" against Sigma SIA™.
- Clinical Trial: 300 samples were used for the clinical trial.
- Combined Data: The clinical trial data (300 samples) was combined with the initial testing data for overall performance metrics. The total combined sample size is not explicitly stated, but it would be 300 + (number of samples in initial testing).
- Data Provenance: The document states "Pompano Beach, Florida" as the sponsor's location, implying the study was likely conducted in the United States. The text does not explicitly state whether the data was retrospective or prospective. Given the mention of "Initial testing" and a "clinical trial," it's highly probable the data includes prospectively collected samples, especially for the clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a laboratory analytical method, not human experts. Therefore, the concept of "number of experts" and their "qualifications" is not applicable in this context. GC/MS is considered a gold standard for confirming the presence of drugs and their metabolites in urine.
4. Adjudication method for the test set
Not applicable. Ground truth was established by GC/MS, an objective analytical method, not human interpretation requiring adjudication.
5. 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
Not applicable. This device is a rapid diagnostic test for drug screening, not an AI-assisted diagnostic imaging or interpretation tool. It does not involve human readers interpreting complex images or data with or without AI assistance. The test provides a color band result.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, effectively, a standalone performance study was done. The device itself (a chromatographic absorbent device) produces a result (color band absence/presence), and its performance was directly compared against GC/MS. While a human visually interprets the color bands, the performance metrics (sensitivity, specificity, accuracy, agreement) directly reflect the device's ability to correctly identify the presence or absence of Methamphetamine without further human interpretation beyond reading the test result.
7. The type of ground truth used
The type of ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly reliable and recognized analytical method for drug confirmation. This falls under the category of objective laboratory testing results or a "gold standard" comparison.
8. The sample size for the training set
The document does not explicitly mention a separate "training set" or "validation set" in the context of machine learning. The studies described are performance evaluations against a gold standard. The device itself is a chemical-based assay, not a machine learning algorithm that requires training data in the typical sense.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a machine learning training set. The ground truth for the performance evaluation sets (initial testing and clinical trial) was established by GC/MS.
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