(51 days)
VITEK® 2 AST - ST Cefotaxime is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST - ST Cefotaxime is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Cefotaxime has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections: Streptococcus pneumoniae. Streptococcus pyogenes (Group A betahemolytic streptococci), Streptococcus spp.
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli. Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
The VITEK® 2 AST - ST Cefotaxime for Streptococcus species has the following concentrations in the card: 0.25, 0.5, 1, and 2 ug/ml (equivalent standard method concentration by efficacy in uq/ml). The MIC result range for the VITEK 2 card is ≤ 0.125 ~ ≥ 8 µg/ml.
The provided document describes the VITEK® 2 AST - ST Cefotaxime, an antimicrobial susceptibility test system for Streptococcus species. Below is a summary of the acceptance criteria and the study that proves the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is assessed through Essential Agreement (EA), Evaluable Essential Agreement (Eval EA), Category Agreement (CA), and the rates of major (maj), very major (vmj), and minor (min) discrepancies, against a reference broth microdilution method. While explicit numerical acceptance criteria for each metric are not stated in the provided text, the implied acceptance is based on "high agreement" and low error rates, consistent with guidance documents for AST systems. Typical acceptance criteria for AST systems are often >90% for EA and CA, and low rates for major (
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”