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K Number
K062461
Device Name
C. ALBICANS PNA FISH
Manufacturer
ADVANDX, INC.
Date Cleared
2006-10-25

(63 days)

Product Code
JXB,NZS
Regulation Number
866.2660
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

Not Found

AI/ML Overview

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.

§ 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.