FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Amedica Drug Screen Phencyclidine Test is an in vitro diagnostic test for the rapid detection of Phencyclidine in human urine at a cutoff of 25 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Device Description

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 25 ng/ml.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Amedica Drug Screen Phencyclidine Test, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Detection of Phencyclidine at a cutoff of 25 ng/ml in human urine	Correlation Study: > 93% agreement with GC/MS results.
Qualitative visual result	Demonstrated that the device can be used by professionals to obtain a visual, qualitative detection of drugs of abuse.
Substantial equivalence to predicate device (Rapid Diagnostics Phencyclidine Test)	The results of the correlation study and a comparison with the Rapid Diagnostics Phencyclidine test demonstrated substantial equivalence.

Note: The document states "This study produced > 93% agreement with GC/MS results," implying this met their acceptance for accuracy.

Study Details

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not explicitly stated. The document mentions "blind-labeled clinical specimens" for the correlation study and a "clinical site study" at two certified laboratories. It does not provide the exact number of specimens used in either study.
Data Provenance: Not explicitly stated, but "clinical specimens" and "clinical site study" at certified laboratories imply real-world human urine samples. There is no mention of country of origin, but the manufacturer is based in California, USA, suggesting the studies likely occurred in the USA. The studies were retrospective as they involved "blind-labeled clinical specimens that have been measured by GC/MS," indicating the GC/MS results were pre-existing.

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

The ground truth for the test set was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly accurate analytical method, not human experts in this context. Therefore, the number and qualifications of human experts for ground truth are not applicable here.

4. Adjudication method for the test set

Not applicable. The ground truth was established by GC/MS, an objective chemical method, not through human adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This device is an immunoassay for drug detection, where the "reading" is a visual interpretation of a test line, not a complex image interpretation typically associated with AI in an MRMC study. The product's intended use is for "professionals" but does not describe any human-in-the-loop AI assistance.

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

Yes, the performance evaluation primarily focuses on the standalone performance of the immunoassay itself. The "correlation study using blind-labeled clinical specimens that have been measured by GC/MS" directly assesses the device's accuracy without explicit mention of human interpretation variability. The "clinical site study" confirms its usability by professionals to obtain a visual result, but the core performance data comes from the comparison to GC/MS.

7. The type of ground truth used

GC/MS (Gas Chromatography/Mass Spectrometry): This is a gold standard analytical method for identifying and quantifying substances in a sample, providing a highly reliable and objective ground truth.

8. The sample size for the training set

Not applicable. This device is a diagnostic immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on the chemical reactions and design of the test strip.

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

Not applicable, as there is no "training set" for this type of device.

Summary

Regulation Number and Section

N/A