(174 days)
The RapidTox™ is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette).
Rapid Tox is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels:
| Compound | Test
Abbreviation | Level (ng/ml) |
|----------------------------------------------------------|----------------------|---------------|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 |
| Barbiturates (secobarbital) | BAR | 300 |
| Benzodiazepine (oxazepam) | BZO | 300 |
| Cocaine (benzoylecgonine) | COC | 300 |
| MDMA ((+/-)3,4-methylenedioxy-methamphetamine) (Ecstasy) | MDMA | 1000 |
| Methadone | MTD | 300 |
| Methamphetamine ((+/-)methamphetamine HCl) | MET | 1000 |
| Opiates (morphine-3-b-D-glucuronide) | OPI | 300 |
| | | 2000 |
| Oxycodone | OXY | 100 |
| Phencyclidine (phencyclidine HCI) | PCP | 25* |
| Propoxyphene/Norpropoxyphene | PPX | 300 |
| THC/Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50* |
| Tricyclic Antidepressants (nortriptyline) | TCA | 1000 |
Rapid Tox provides only a preliminary analytic test result. More specific alternative chemical methods must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
The Test is recommended for professional use. It is not intended for over-the-counter sales to nonprofessionals.
The RapidTox™ is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette).
The provided document describes the FDA 510(k) clearance for the RapidTox™ device, a lateral flow immunoassay for detecting drugs of abuse in urine. However, it does not contain explicit information regarding acceptance criteria, a detailed study design, or specific performance metrics (like sensitivity, specificity, accuracy) derived from such a study.
The document primarily focuses on the regulatory submission and FDA's determination of substantial equivalence to predicate devices, along with the device's intended use and detection levels for various substances.
Therefore, many of the requested details cannot be extracted directly from this document. I will fill in what can be inferred or stated based on the given text and indicate where information is missing.
Acceptance Criteria and Device Performance (Inferred/Not Explicitly Stated)
The document lists the detection levels for various compounds. For a lateral flow immunoassay in a regulatory context, acceptance criteria would typically revolve around demonstrating that the device can accurately detect these compounds at or above the specified cutoff levels (sensitivity) and not produce false positives in the absence of the drug (specificity).
Table of (Inferred) Acceptance Criteria and Device Performance
| Compound | Test Abbreviation | Target Cutoff Level (ng/ml) | Reported Performance (Inferred from device's function as a "qualitative detection" at specified levels) |
|---|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 | Qualitatively detects Amphetamine at or above 1000 ng/ml. |
| Barbiturates (secobarbital) | BAR | 300 | Qualitatively detects Barbiturates at or above 300 ng/ml. |
| Benzodiazepine (oxazepam) | BZO | 300 | Qualitatively detects Benzodiazepine at or above 300 ng/ml. |
| Cocaine (benzoylecgonine) | COC | 300 | Qualitatively detects Cocaine at or above 300 ng/ml. |
| MDMA ((+/-)3,4-methylenedioxy-methamphetamine) (Ecstasy) | MDMA | 1000 | Qualitatively detects MDMA at or above 1000 ng/ml. |
| Methadone | MTD | 300 | Qualitatively detects Methadone at or above 300 ng/ml. |
| Methamphetamine ((+/-)methamphetamine HCl) | MET | 1000 | Qualitatively detects Methamphetamine at or above 1000 ng/ml. |
| Opiates (morphine-3-b-D-glucuronide) | OPI | 2000 | Qualitatively detects Opiates at or above 2000 ng/ml. |
| Oxycodone | OXY | 100 | Qualitatively detects Oxycodone at or above 100 ng/ml. |
| Phencyclidine (phencyclidine HCl) | PCP | 25* | Qualitatively detects Phencyclidine at or above 25 ng/ml. |
| Propoxyphene/Norpropoxyphene | PPX | 300 | Qualitatively detects Propoxyphene/Norpropoxyphene at or above 300 ng/ml. |
| THC/Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50* | Qualitatively detects THC/Cannabinoids at or above 50 ng/ml. |
| Tricyclic Antidepressants (nortriptyline) | TCA | 1000 | Qualitatively detects Tricyclic Antidepressants at or above 1000 ng/ml. |
Note: The actual acceptance criteria (e.g., minimum sensitivity and specificity percentages) for the study are not specified in this document, only the target detection levels.
Study Details:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For drug tests, ground truth is typically established by a gold standard laboratory method.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Adjudication methods are typically used when subjective expert interpretation is involved. For a diagnostic test like this, a confirmatory objective method is usually employed as the ground truth.
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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. The RapidTox™ is a lateral flow immunoassay, a diagnostic device that produces a visual result (lines) for drug detection. It is not an AI-powered system, nor does it involve human "readers" in the sense of image interpretation where an AI would assist. Its interpretation is generally objective based on the presence or absence of a line.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As noted above, this is not an AI algorithm. Its performance is inherent to the chemical reactions and design of the immunoassay itself in detecting the target analytes. The device is standalone in the sense that it provides a direct qualitative result without further interpretation by an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The document states: "More specific alternative chemical methods must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
- Therefore, the ground truth used for validating the immunoassay would be GC/MS (Gas Chromatography/Mass Spectrometry), which is an objective, highly accurate analytical method for drug identification and quantification.
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The sample size for the training set:
- Not Applicable. This is a traditional immunoassay, not a machine learning or AI model, so there is no "training set" in the computational sense. The device's performance is developed and optimized through chemical formulation and engineering, not algorithm training.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, this question does not apply to this device. The 'ground truth' for the development and validation of the immunoassay itself (e.g., establishing the reactivity of antibodies, optimizing cutoff levels) would be based on precise laboratory measurements using known concentrations of analytes and reference methods like GC/MS.
§ 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).