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C. albicans PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of Candida albicans on smears made from yeast positive blood cultures.

Subculturing of yeast positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

C. albicans PNA FISH is indicated for use as an aid in the diagnosis of C. albicans fungemia.

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This document is a marketing authorization from the FDA for a device called "C. albicans PNA FISH™". It is a letter confirming the device's substantial equivalence to previously marketed devices. However, the letter itself does not contain the detailed study information, acceptance criteria, or performance data requested in the prompt. This type of information is typically found in the 510(k) summary or the full submission.

Therefore, I cannot fulfill the request using only the provided text. The document primarily focuses on regulatory approval and classification, not the detailed scientific evidence supporting the device's performance.

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C. albicans PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Candida albicans from blood cultures.

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The provided text is a 510(k) premarket notification letter from the FDA to AdvanDx Inc. regarding their C. albicans PNA FISH device. This document primarily focuses on FDA clearance for market entry based on substantial equivalence to a predicate device. It defines the device, its intended use, and regulatory classification.

However, the document does not contain the acceptance criteria or the details of a study proving the device meets those criteria, as requested in the prompt. Specifically, the following information is not provided:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document merely confirms that the device has been found substantially equivalent to a legally marketed predicate device, enabling it to proceed to the market. Details about specific performance studies and their results are typically found in the 510(k) submission itself, not in the FDA's clearance letter.

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