Search Results

The Ameditech DrugSmartCup™ is an In Vitro screen test device for the qualitative detection of 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.

Not Found

Here's a breakdown of the acceptance criteria and study information for the Ameditech DrugSmartCup™ based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA letter does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity thresholds). However, it implies that the device's performance, as demonstrated in the submission, was deemed substantially equivalent to legally marketed predicate devices. The listed "Indications for Use" and the table of "Cutoff concentrations" define the intended analytical performance of the device.

Reported Device Performance: The document only states that the device was found "substantially equivalent" to legally marketed predicate devices for the specified indications. It does not provide specific performance metrics like sensitivity, specificity, or accuracy percentages from Ameditech's study. The cutoff concentrations in the table are the definition of the expected performance for a positive/negative result.

2. Sample Size Used for the Test Set and Data Provenance

The provided FDA letter does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail would typically be found in the 510(k) submission itself, not the FDA's decision letter.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The provided FDA letter does not contain information about the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The provided FDA letter does not specify any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not applicable to this type of in-vitro diagnostic device (a qualitative screen test for drugs in urine). MRMC studies are typically used for imaging diagnostics where human readers interpret results. This device produces a visual, qualitative result that is read directly, not interpreted by multiple human readers in a comparative setting against an AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this device inherently functions as a standalone test. It's an "In Vitro screen test device for the qualitative detection of drugs in human urine" that provides a "visual, qualitative result." While human eyes read the result, there is no separate "algorithm" being evaluated against human-in-the-loop performance in the way an AI algorithm for medical imaging would be. The device itself is the "algorithm" in a chemical sense.

7. The Type of Ground Truth Used

The ground truth for a drug screening device like this would typically be established by a more definitive analytical method. 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, GC/MS is the type of ground truth used to determine the actual presence and concentration of drugs to validate the device's accuracy.

8. The Sample Size for the Training Set

The provided FDA letter does not contain information regarding the sample size used for any training set. This device is not an AI/ML algorithm that is "trained" in the typical sense; it is a chemical immunoassay.

9. How the Ground Truth for the Training Set Was Established

As this is a chemical immunoassay rather than a machine learning algorithm requiring a "training set" in the AI sense, this question is not directly applicable. However, if this refers to the development and calibration of the assay, the "ground truth" for calibrating the device would involve spiking urine samples with known concentrations of the target analytes and confirming those concentrations with a gold standard like GC/MS to ensure the device correctly identifies positive/negative relative to the established cutoffs.

Ask a specific question about this device