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Acro Rapid Opiate Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine at a cutoff of 2000 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug 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) analysis is preferred.

A lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine.

This is a FDA 510(k) premarket notification for the Acro Rapid Opiate Urine Test, a device used for the qualitative detection of Opiate in human urine. The document is a letter from the FDA to Acro Biotech LLC, indicating that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The provided document, being an FDA 510(k) clearance letter, primarily establishes substantial equivalence without detailing specific acceptance criteria or performance metrics in a tabular format within the available text.

However, the "Indications for Use" section mentions:

• Qualitative detection of Opiate in human urine at a cutoff of 2000 ng/mL.
• The test is used to obtain a visual qualitative result and is intended for laboratory use only.

To infer performance, we can deduce that the device must demonstrate sufficient accuracy (sensitivity and specificity) around this cutoff for qualitative detection. Since this document declares substantial equivalence, it implies that the device's performance is comparable to or better than existing legally marketed predicate devices for the same intended use.

Without the actual study report or further sections of the 510(k) submission, specific reported device performance metrics like sensitivity, specificity, accuracy, or repeatability at the 2000 ng/mL cutoff are not quantifiable from the given text.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide any information regarding the sample size used for the test set, the country of origin of the data, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide any information regarding the number of experts used to establish the ground truth or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not provide any information regarding an adjudication method for the test set.

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

This device is an "Acro Rapid Opiate Urine Test," described as a "lateral flow, one-step immunoassay." This type of device is a diagnostic test kit that provides a direct visual qualitative result, not an AI-powered image analysis or diagnostic tool that would involve "human readers" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.

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

This device is a standalone test kit. Its performance is inherently "algorithm only" in the sense that it produces a direct visual qualitative result based on its chemical/immunological reactivity. There isn't an "algorithm" in the computational sense applied to interpret a human observation; rather, the device itself provides the result for interpretation. So, yes, its performance would be assessed as a standalone device, but not in the context of a computational algorithm.

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

The "Indications for Use" states: "In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred." This strongly indicates that Gas Chromatography/ Mass Spectroscopy (GC/MS) is the preferred method for establishing the ground truth (the reference standard or true positive/negative for Opiate presence in urine).

8. The sample size for the training set

The document does not provide any information regarding the sample size for the training set. This context is less relevant for a lateral flow immunoassay compared to machine learning models, as these devices are designed and optimized based on chemical principles and reagent characteristics rather than being "trained" on data in the same way an AI model is.

9. How the ground truth for the training set was established

The document does not provide any information on how ground truth for a "training set" (if such a concept is applied in this context of immunoassay development) was established. As mentioned above, for this type of device, development involves chemical formulation and optimization, not data-driven "training" as in AI. However, if any reference samples were used during development, it is highly probable that GC/MS would have been used to confirm the presence and concentration of opiates in those samples.

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