(187 days)
The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbital], 300 ng/ml; benzodiazepine [oxazepam], 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml).
The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-ofcare (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide 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) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfics the criteria for workplace testing established under DOT and SAMHSA.
The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine.
This looks like a 510(k) clearance letter for an in-vitro diagnostic device, specifically a drug screening panel. These types of documents typically do not contain the detailed study information you are requesting, such as sample sizes for training/test sets, ground truth establishment, or multi-reader studies. The FDA clearance is based on the device being "substantially equivalent" to a legally marketed predicate device, rather than a full de novo evaluation of clinical performance with detailed statistical studies.
However, I can extract the acceptance criteria based on the information provided in the "Statement for Indications For Use" and generally infer what a performance study for such a device would entail.
Please note: The following reconstruction is an inference based on the typical requirements for this type of device and what is explicitly stated (or not stated) in the provided text. The document itself does not contain a detailed study report.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a qualitative drug test like this are typically based on detecting the target drug at or above a specified cut-off concentration. The device's "performance" is its intended ability to achieve this, implying a certain level of sensitivity and specificity around these cut-offs. The document does not provide a table of performance metrics (sensitivity, specificity, accuracy, positive/negative predictive values) from an actual study, but it defines the cut-off levels which would be the basis for evaluating performance.
| Analyte (Drug) | Cut-off Level (ng/ml) | Acceptance Criteria (Implied) | Reported Device Performance (Inferred as meeting criteria for clearance) |
|---|---|---|---|
| Amphetamine | 1000 | Detect amphetamine at or above 1000 ng/ml. | Device cleared, implying successful demonstration against criteria. |
| Barbiturate | 300 | Detect secobarbital (as representative barbiturate) at or above 300 ng/ml. | Device cleared, implying successful demonstration against criteria. |
| Benzodiazepine | 300 | Detect oxazepam (as representative benzodiazepine) at or above 300 ng/ml. | Device cleared, implying successful demonstration against criteria. |
| Cocaine | 300 | Detect cocaine at or above 300 ng/ml. | Device cleared, implying successful demonstration against criteria. |
| Methadone | 300 | Detect methadone at or above 300 ng/ml. | Device cleared, implying successful demonstration against criteria. |
| Methamphetamine | 1000 | Detect methamphetamine at or above 1000 ng/ml. | Device cleared, implying successful demonstration against criteria. |
| Opiates | 2000 | Detect opiates at or above 2000 ng/ml. | Device cleared, implying successful demonstration against criteria. |
| Phencyclidine | 25 | Detect phencyclidine at or above 25 ng/ml. | Device cleared, implying successful demonstration against criteria. |
| Cannabinoid | 50 | Detect cannabinoid at or above 50 ng/ml. | Device cleared, implying successful demonstration against criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). For in-vitro diagnostic devices, studies typically involve testing a statistically significant number of urine samples, both negative and spiked/positive at various concentrations relative to the cut-off.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For this type of device, ground truth is established through a definitive reference method, not typically by expert interpretation of results. Therefore, the concept of "number of experts" is not directly applicable in the same way it would be for an imaging AI device.
4. Adjudication Method for the Test Set
Not applicable for a chemical assay. The ground truth is determined by the reference method (e.g., GC/MS).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC study is not applicable for this type of in-vitro diagnostic device. This device is a diagnostic test, not an AI or imaging interpretation tool that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is essentially a "standalone" immunochromatographic test. Its performance is evaluated purely on its ability to correctly identify the presence or absence of drugs against a reference standard. There isn't an "algorithm" in the AI sense, but rather a chemical reaction and visual readout. Human intervention is in performing the test and reading the results, but the core performance is inherent to the device's chemistry.
7. The Type of Ground Truth Used
The document explicitly states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA)."
Therefore, the ground truth for performance studies of this device would typically be established using:
- GC/MS (Gas Chromatography/Mass Spectrometry) for quantitative confirmation of drug presence and concentration.
- Spiked samples (negative urine samples to which known concentrations of drugs are added) would also be used to rigorously test performance around the cut-off levels.
8. The Sample Size for the Training Set
The concept of a "training set" in the context of machine learning (AI) does not directly apply to this immunochromatographic test. There is no AI algorithm being "trained" in the typical sense. The device's formulation and manufacturing process are developed and optimized, but not through a machine learning training paradigm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there's no training set for an AI algorithm.
§ 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).