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Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis and identification of Candida glabrata and/or Candida krusei from positive blood cultures. The test does not distinguish between C. glabrata and C. krusei. The test does not distinguish between C. albicans and C. parapsilosis.

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The provided text is a 510(k) clearance letter for a medical device and does not contain the detailed information required to answer the prompt. It primarily focuses on the regulatory approval of the "AdvanDx Ycast Traffic Light PNA FISH" device, stating its intended use and classification.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test sets, data provenance, or details of expert involvement in ground truth establishment.
• Mention of adjudication methods, MRMC studies, or standalone algorithm performance.
• Details about the type of ground truth used (beyond implying identification of microorganisms).
• Information on the training set size or how its ground truth was established.

Therefore, I cannot provide the requested information based on the provided input. This document is a regulatory approval letter, not a summary of the device's validation study.

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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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Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit is used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens.

Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit

The provided text is a letter from the FDA regarding a 510(k) clearance for the "YeasTest™ Diagnostic Kit." This document does not contain any information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or comparative effectiveness studies (MRMC or standalone).

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and compliance. The "Indications For Use" section states that the device is "used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens," but provides no data or performance specifications.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided input.

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