YEAST TRAFFIC LIGHT PNA FISH

• K Number: K080719
• Device Name: YEAST TRAFFIC LIGHT PNA FISH
• Manufacturer: ADVANDX, INC.
• Date Cleared: 2008-09-12 ( 183 days)
• Product Code: JXB
• Regulation Number: 866.2660
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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.

Device Description

Not Found

AI/ML Overview

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.

Regulation Number and Section

§ 866.2660 Microorganism differentiation and identification device.

(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.