(195 days)
GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli, and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gramnegative rods observed on Gram stain.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli, and/or K, pneumoniae, and/or P. aeruginosa bacteremia.
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This document is a 510(k) clearance letter for the AdvanDX GNR Traffic Light PNA FISH Identification Kit. It does not contain the detailed study information required to answer your request.
The letter acknowledges the substantial equivalence determination for the device based on a premarket notification. It outlines the regulatory classification, general controls, and responsibilities of the manufacturer. However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Details on multi-reader multi-case (MRMC) studies or standalone performance.
- The type of ground truth used, or sample sizes and ground truth establishment methods for a training set.
To obtain this information, you would typically need to refer to the original 510(k) submission document (K101558) itself, which would contain the validation study details.
§ 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.