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K Number
K060621
Device Name
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-
Manufacturer
TDS HOLDINGS INC.
Date Cleared
2006-04-21

(44 days)

Product Code
JWY,LRG
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

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the addition of Ertapenem in the dilution range of 0.002 -16 ug/ml for gram negative organisms and 0.015-64ug/ml for gram positive organisms to the Sensititre 18 - 24 hour MIC panel for testing gram positive and gram negative isolates. The approved primary "Indications for Use" and clinical significance of Ertapenem is for: Staphylococcus species (methicillin-susceptible strains), Streptococcus agalactiae, Steptococcus pyogenes, Escherichia coli, and Klebsiella pneumoniae. In vitro data, without clinical correlation is provided for: Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii, Proteus mirabilis, Proteus vulgaris, and Serratia marcescens.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a Susceptibility Test Panel for Ertapenem. It grants market clearance for the device but does not contain information on acceptance criteria or the study details that prove the device meets these criteria.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided document.

To answer your request, I would need a document that describes:

  • The specific acceptance criteria (e.g., accuracy percentages, agreement rates).
  • The design and results of a clinical or performance study.
  • Details about the ground truth establishment, sample sizes, and expert qualifications.

§ 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).