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K Number
K971694
Device Name
ETEST FOR CEFTAZIDIME
Manufacturer
AB BIODISK
Date Cleared
1997-06-30

(54 days)

Product Code
JWY
Regulation Number
866.1640
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
Predicate For
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 non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterocccus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which 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 Etest 510(k) application is for MIC determination of Ceftazidime in the range of 0.016 - 256 µg/ml with Gram negative and Gram positive aerobic bacteria and H. influenzae.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called Etest® for Ceftazidime. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information about acceptance criteria or the study that proves the device meets the acceptance criteria.

The letter focuses on the regulatory approval for marketing the device for its stated "Indications For Use," which are for in vitro diagnostic determination of antimicrobial susceptibility to Ceftazidime for various bacterial species.

Therefore, I cannot provide the requested information based on the provided text. The document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication method.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information about standalone algorithm performance.
  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.

§ 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).