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K Number
K042390
Device Name
ETEST FOR GEMIFLOXACIN
Manufacturer
AB BIODISK
Date Cleared
2004-11-19

(78 days)

Product Code
JWY
Regulation Number
866.1640
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For in vitro diagnostic use:

Etest is a quantitative technique for the determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaxeae, Pseudomonas, Staphylooocus and Enteroous species and fastidious bacteria, such as anaerobes, Pneumooocus, Streptocous, Gonocous and Haemophilus species. The system comprises a predefined antibiotic gradient that is used to determine the minimum inhibitory concentration (MIC) in µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This 510(k) submission is for an additional drug for Etest for MIC determination of Gemifloxacin MIC 0.002 - 32 µg/ml with Enterobacteriaceae, S. pneumoniae and H. influenzae.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the Etest® Gemifloxacin 0.002-32 µg/mL. This document is a regulatory approval, and as such, it does not contain the detailed study information required to answer the prompt.

Specifically, the document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Information on experts used to establish ground truth or their qualifications.
  4. Adjudication methods.
  5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Results of a standalone algorithm performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device was approved based on its substantial equivalence to a predicate device, not necessarily on a new, comprehensive study detailed within this document. The "Indications for Use" section further clarifies that the submission is "for an additional drug for Etest for MIC determination of Gemifloxacin MIC 0.002 - 32 µg/ml with Enterobacteriaceae, S. pneumoniae and H. influenzae."

To obtain the requested information, one would need to refer to the full 510(k) submission document (K042390) itself, which would contain the study results and details that supported the substantial equivalence claim.

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).