(260 days)
VITEK 2 AST-Yeast Anidulafungin is designed for antifungal susceptibility testing of Candida species and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. VITEK 2 AST-Yeast Anidulafungin is a quantitative test. Anidulafungin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.
Active in vitro and in clinical infections: Candida albicans Candida glabrata Candida parapsilosis Candida tropicalis
In vitro data are available, but clinical significance is unknown: Candida guillermondii Candida krusei
The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh (1) and Gerlach(2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3).
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.
VITEK® 2 AST-YS Anidulafungin has the following concentrations in the card: 0.0625, 0.125, 0.5, 2, and 8 (equivalent standard method concentration by efficacy in ug/mL).
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text.
Device: VITEK 2 AST-Yeast Anidulafungin
Indications for Use: Antifungal susceptibility testing of Candida species (C. albicans, C. glabrata, C. parapsilosis, C. tropicalis, C. guilliermondii, C. krusei) as a laboratory aid in determining in vitro susceptibility to antifungal agents.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state the acceptance criteria in a separate table directly defining thresholds for Essential Agreement (EA), Category Agreement (CA), or error rates (VME, ME, mE) that the device must meet for approval. Instead, it presents the results of the performance study and implies that these results were deemed "acceptable" by the FDA. The performance is compared to the "CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009)". This guidance document would contain the specific acceptance criteria.
However, based on the presented "Performance Overview" (Page 7) and the overall context of AST device approvals, typical acceptance criteria for Essential Agreement and Category Agreement are usually in the range of 90-95% or higher, with Very Major Error (VME) and Major Error (ME) rates usually being low (e.g.,
§ 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).