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The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. 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 III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test uses multiple test strips in 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).

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) clearance letter for a drug screening device, not a detailed study report. Therefore, much of the requested information (like specific sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies) is not present in this type of regulatory correspondence. The document focuses on the intended use and performance characteristics as claimed by the manufacturer and accepted by the FDA based on a comparison to predicate devices, rather than a detailed accounting of a specific clinical performance study.

However, I can extract the acceptance criteria as presented for each drug panel.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for each drug are defined by the "Cutoff (ng/ml)" concentration. The device is expected to qualitatively detect the presence of the specified drug at or above these cutoff concentrations. The document does not provide a table of reported device performance in terms of sensitivity, specificity, accuracy, or concordance with a gold standard from a specific study within this letter. Instead, it states the intended use is for qualitative detection relative to these cutoffs.

Specific Study Information (Based on available document content):

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in this document.
   • Data Provenance: Not specified in this document. Typically, for in vitro diagnostic devices, studies involve spiked urine samples and/or clinical urine samples. The document does not state country of origin or if prospective/retrospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not specified. For in vitro diagnostic assays, ground truth is typically established by definitive analytical methods (like GC/MS) rather than expert consensus on visual interpretation.

3. Adjudication method for the test set:

   • Not applicable/Not specified. This refers to consensus among human readers for image interpretation, which is not relevant for this type of qualitative chemical test.

4. 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 not an AI-assisted diagnostic device, nor does it involve human readers interpreting complex images. It is a rapid qualitative immunoassay.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Partially applicable. The device is a standalone qualitative test. The "output" is a visual indication (e.g., lines on a strip). However, the document states, "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." This indicates that while the device itself performs the detection without human intervention, its results require expert clinical interpretation and confirmation by a more specific method.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The document implies that the ultimate ground truth for confirmation is a "more specific alternate chemical method," with "Gas Chromatography/Mass Spectroscopy (GC/MS) [being] the preferred confirmation method."

7. The sample size for the training set:

   • Not specified in this document. Immunoassays are often "trained" or optimized during development using various concentrations of analytes and interferents, but this is a manufacturing/development process, not typically reported with a "training set" size in the same way as an AI algorithm.

8. How the ground truth for the training set was established:

   • Not specified in this document. As with the test set, it would typically involve spiking known concentrations of drugs into urine samples or using characterized clinical samples, with definitive analytical methods (like GC/MS) used to establish the true concentration/presence.

Summary of Device and Approval Context:

This FDA 510(k) clearance letter indicates that the Ameditech ImmuTest Multi-Drug Screen Panel III is a qualitative in-vitro diagnostic device for detecting multiple drugs in human urine. Its "acceptance criteria" are the specified cutoff concentrations for each drug metabolite. The FDA determined that this device is "substantially equivalent" to legally marketed predicate devices, meaning that its performance, safety, and effectiveness are considered comparable. The letter does not provide a detailed clinical study report but rather acts as regulatory approval based on the manufacturer's submission demonstrating substantial equivalence. The "study" mentioned generally refers to the performance data submitted by the manufacturer to demonstrate this substantial equivalence to predicate devices, which would have included data to support the stated cutoffs and qualitative detection capabilities.

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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.

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.

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