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The Diagnostic Chemicals Limited's Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). intended to modellio balleyfato to the diagnosis of salicylate toxicity and overdose.

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The provided text is a 510(k) clearance letter for a Salicylate test system. This type of document does not typically contain the detailed information requested regarding acceptance criteria, study design, or ground truth establishment relevant to AI/ML device performance.

The letter confirms that the device, Salicylate, Cat.Nos.511-20 and 511-40, is substantially equivalent to legally marketed predicate devices for measuring salicylate levels in human serum or plasma to aid in the diagnosis of salicylate toxicity and overdose.

Therefore, I cannot provide the requested information based on the input text. The information is pertaining to a traditional in vitro diagnostic device, not an AI/ML device which would involve specific performance metrics and validation studies against a ground truth as outlined in your request.

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For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use.

This enzymatic Salicylate Assay provides a rapid, specific and simplified method for salicylate determination. It is based on the action of salicylate hydroxylase on salicylate and NADH which results in a decrease in absorbance proportional to the amount of salicylate present. The test can be adapted to automated instruments resulting in rapid, accurate results required by physicians.

The provided document is a 510(k) premarket notification letter for the Salicylate-SL Assay. It confirms the device's substantial equivalence to a predicate device and allows it to be marketed. However, this document does not contain the detailed acceptance criteria or the study data that would demonstrate the device meets those criteria.

A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical efficacy studies akin to PMA (Premarket Approval) applications. While "performance" might be mentioned in the context of the device's mechanism, the letter does not include a table of acceptance criteria or reported device performance in the way a study report would.

Therefore, for your request, I can only extract limited information based on what is provided:

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

• Not provided in this document. The letter refers to the device being "substantially equivalent," which implies its performance is comparable to the predicate device, but specific metrics and acceptance criteria for that equivalence are not detailed here.

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

• Not provided in this document. The letter does not detail any specific test set or study design.

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):

• Not provided in this document.

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

• Not provided in this document.

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 device is an in vitro diagnostic assay, not an imaging AI device that would involve human readers interpreting images.

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

• Not applicable in the typical sense for AI algorithms. This is a laboratory assay. The "algorithm" here is the enzymatic reaction and measurement. The letter mentions it "can be adapted to automated instruments," implying standalone operation as a lab test, but no separate "standalone performance study" in the context of AI is discussed.

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

• Not explicitly stated in this document. For an in vitro diagnostic device like this, ground truth would typically be established through a reference method or validated gold standard test for salicylate concentration in serum. The document mentions "Salicylate has been traditionally measured by the 'Trinder Reaction'," suggesting this might be the comparator for method development, but it doesn't specify how ground truth was established for the specific testing of this device.

8. The sample size for the training set:

• Not provided in this document.

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

• Not provided in this document.

Summary of Device and Indications:

• Device Name: Salicylate-SL Assay
• Indications for Use: For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use.
• Mechanism: Enzymatic assay based on the action of salicylate hydroxylase on salicylate and NADH, resulting in a decrease in absorbance proportional to the amount of salicylate present. This is designed to be more rapid, specific, and simplified than the traditional Trinder Reaction and adaptable to automated instruments.
• Purpose: Rapid quantitation of salicylate is necessary for effective patient management in cases of salicylate overdose (due to accidental ingestion or attempted suicidal poisoning), which can lead to central nervous system disturbances, gastrointestinal tract issues, encephalopathy, and renal failure.

To obtain the detailed information about acceptance criteria and study data, one would typically need to review the full 510(k) submission, including the specific performance data sections, which are not part of this FDA clearance letter.

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