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K Number
K063127
Device Name
ENTEROCOCCUS FAECALIS PNA FISH
Manufacturer
ADVANDX, INC.
Date Cleared
2006-12-22

(70 days)

Product Code
OAH
Regulation Number
866.3740
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

E. faecalis PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is an FDA 510(k) clearance letter for the "E. faecalis PNA FISH" device, indicating its substantial equivalence to a predicate device.

The letter mentions the device's "Indications for Use" as a "qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures." However, it does not provide any specific information regarding:

  1. Acceptance criteria
  2. Reported device performance
  3. Sample size, data provenance for the test set
  4. Number/qualifications of experts for ground truth
  5. Adjudication method
  6. Multi-reader multi-case (MRMC) study results or effect size
  7. Standalone performance
  8. Type of ground truth used
  9. Sample size for the training set
  10. How the ground truth for the training set was established

These details would typically be found in the 510(k) submission summary or detailed study reports, which are not part of this clearance letter.

§ 866.3740

Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney 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.