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Immunoassay for the qualitative detection of Tricyclic Immunoassay for the quarteline at cutoff 1000 ng/mL) in human urine to assist in screening of drug of abuse samples.

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This looks like a 510(k) clearance letter for the AccuSign® TCA device, which is an immunoassay for the qualitative detection of Tricyclic Antidepressants (TCA) in human urine. Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter from the FDA is a notification of substantial equivalence for marketing the device, not a detailed technical report of the device's performance or the studies conducted. It refers to a 510(k) submission (K981801) which would contain the study details, but the submission itself is not provided here.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text.

To answer your questions, I would need access to the actual 510(k) submission document (K981801) or a similar technical report that describes the device's performance characteristics and the clinical or analytical studies conducted.

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Immunoassay for the qualitative detection of TCA in human urine to assit in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs

Not Found

This document is a letter from the FDA regarding the 510(k) premarket notification for the "AccuSign® TCA-Rapid One-Step Tricyclic Antidepressant Assay" device. It does not contain the detailed study information required to fill out the table and answer all questions related to acceptance criteria and device performance.

The letter simply states that the FDA has reviewed the submission and determined the device to be "substantially equivalent" to predicate devices, allowing it to be marketed. It does not provide the performance data that would typically be found in a 510(k) summary or the actual study report.

Therefore, I cannot provide a detailed response to most of your questions based on the provided text.

Here's what can be inferred or stated about the information requested, with limitations:

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

• Cannot be provided. The document does not contain acceptance criteria or performance data for the AccuSign TCA device. It only states that the device was found substantially equivalent.

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

• Cannot be determined from this document. This information would be in the 510(k) submission, not the FDA's clearance letter.

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)

• Cannot be determined from this document. This information is not provided.

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

• Cannot be determined from this document. This information is not provided.

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 / Cannot be determined. This device is an immunoassay for drug detection, not an AI-assisted diagnostic imaging device that would typically involve human readers.

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

• Yes (for the device itself). The AccuSign TCA is a rapid one-step immunoassay. By its nature, it performs its function (detecting TCA in urine) without human interpretation in the sense of a radiologist reading an image. The result is typically a visual readout (e.g., lines on a test strip). Its performance would be evaluated in a standalone manner, though this document doesn't provide the results.

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

• Most likely a reference method for drug testing. For a drug assay, the ground truth would typically be established by a highly accurate and precise laboratory method, such as Gas Chromatography-Mass Spectrometry (GC-MS) or High-Performance Liquid Chromatography (HPLC), which are considered gold standards for identifying and quantifying substances in biological samples. However, this is an inference based on the type of device, not information directly from the document.

8. The sample size for the training set

• Cannot be determined from this document. This information is not provided. (Note: For immunoassay devices, a "training set" in the machine learning sense is typically not applicable. Instead, "validation batches" and "calibration" are more common terms, but the underlying data used to establish performance is still relevant).

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

• Cannot be determined from this document. (See #7 and #8 for context regarding "training set" for this type of device).

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