(27 days)
EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods. The test does not distinguish between E. coli and K. pneumoniae. Further testing is needed to differentiate E. coli and K. pneumoniae.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
The EK/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the AdvanDx EK/P. aeruginosa PNA FISH device. It confirms the device's substantial equivalence to a legally marketed predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about sample sizes, ground truth establishment, or expert qualifications.
The letter primarily focuses on:
- Device Name: AdvanDx EK/P. aeruginosa PNA FISH
- Regulation Number/Name: 21 CFR 866.2660, Microorganism differentiation and identification device
- Regulatory Class: Class I
- Product Code: JSS, JSZ
- Indications for Use: Multicolor, qualitative nucleic acid hybridization assay for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. It also states that the test does not distinguish between E. coli and K. pneumoniae and serves as an aid in diagnosis.
To answer your specific questions, one would need access to the actual 510(k) submission or the study report that was cited in the submission. The information requested falls under the detailed performance data and clinical evidence typically presented in such submissions, which are not part of this 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.