(62 days)
The Ameditech ImmuTest Multi-Drug Screen Panel II is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.
| Test | Calibrator | Cutoff
(ng/ml) |
|--------------------------------------------|----------------------------------|-------------------|
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| 3,4methylenedioxymethamphetamine
(MDMA) | 3,4methylenedioxymethamphetamine | 500 |
| Methamphetamine (MET1000) | d-Methamphetamine | 1000 |
| Methadone (MTD) | Methadone | 300 |
| Opiates (OPI300) | Morphine | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
This test has three types of test format: card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).
This test is used to obtain a visual, qualitative result and is intended for professional use.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
The Ameditech ImmuTest Multi-Drug Screen Panel II is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test has three types of test format: card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use.
This document is a 510(k) clearance letter for an in vitro diagnostic device, the Ameditech ImmuTest Multi-Drug Screen Panel II. It does not contain the detailed study information typically found in a clinical trial report or a scientific paper. Therefore, I cannot provide a complete answer to your request based solely on the provided text.
However, I can extract the acceptance criteria and some limited information about the device performance and how the ground truth is established, based on what's available in the "Indications for Use" section.
Here's what I can infer and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The "Indications for Use" section lists the cutoff concentrations for each drug panel. These are the established thresholds for a positive result in this qualitative screen test. While the document doesn't explicitly state "acceptance criteria" for the device's performance (e.g., sensitivity, specificity, accuracy), the cutoff concentrations themselves are a critical part of its intended performance. The document only specifies the design of the test (i.e., its cutoff values), not the performance against clinical samples.
| Test | Calibrator | Cutoff (ng/ml) |
|---|---|---|
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| 3,4methylenedioxymethamphetamine (MDMA) | 3,4methylenedioxymethamphetamine | 500 |
| Methamphetamine (MET1000) | d-Methamphetamine | 1000 |
| Methadone (MTD) | Methadone | 300 |
| Opiates (OPI300) | Morphine | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
The document states, "This assay provides only a preliminary result." This implies that the device's performance, while meeting regulatory requirements for a screening test, is not definitive and requires confirmation.
Missing Information: The provided text does not contain any data on the device's actual performance (e.g., sensitivity, specificity, accuracy) from a study against these cutoffs. Therefore, I cannot fill in a "Reported Device Performance" column with actual study results.
2. Sample size used for the test set and the data provenance
Missing Information: This document does not provide any details about the sample size used for performance testing (test set) or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in a separate study report or the 510(k) submission itself, not in the clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: This device is an in vitro diagnostic test for drug screening. The "ground truth" for such tests is typically established through a "more specific alternate chemical method," as stated in the document. Therefore, human experts (like radiologists) are not involved in establishing the ground truth for the test set in this context.
4. Adjudication method for the test set
Missing Information: Not applicable, as human experts are not involved in establishing the ground truth for this type of device. The adjudication method refers to how disagreements among human readers are resolved.
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 is an in vitro diagnostic device, not an AI-powered image analysis tool for human readers. Therefore, an MRMC study and effects of AI assistance for human readers are irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
The device is described as "an In Vitro screen test device for the qualitative detection of multi-drugs in human urine." It provides "a visual, qualitative result" and is "intended for professional use." This strongly suggests it's a standalone test (algorithm only, in the sense of the chemical reactions on the strip providing the result) that is interpreted by a professional, rather than an AI that acts as an adjunct to a human.
The statement "This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result" highlights that while the device is standalone in generating a result, human judgment is critical for its clinical application.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document explicitly states: "In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method."
Therefore, the type of ground truth used for validating the performance of this preliminary screening device would be Gas Chromatography/Mass Spectroscopy (GC/MS) or another highly specific chemical analytical method. This is the gold standard for confirming the presence and concentration of drugs in biological samples.
8. The sample size for the training set
Missing Information: This document does not provide details about a "training set." For in vitro diagnostic devices, the development process might involve numerous experiments and optimization steps, but the concept of a "training set" as used in machine learning (which often implies a distinct, labeled dataset for algorithm development) isn't directly applicable or described here.
9. How the ground truth for the training set was established
Missing Information: As mentioned above, the concept of a "training set" in the context of AI is not directly applicable here. If referring to the internal development process of the assay, the ground truth would similarly be established by highly accurate analytical methods like GC/MS to calibrate and validate the chemical reactions on the test panel.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).