Search Results
Found 1 results
510(k) Data Aggregation
K Number
K072827Device Name
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
Manufacturer
REMEL, INC.
Date Cleared
2007-11-26
(54 days)
Product Code
MJE
Regulation Number
866.1700Why did this record match?
Product Code :
MJE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Remel RPMI 1640 Agar w/ MOPS and 2% Glucose is a solid medium recommended for use with antibiotic gradient-based systems for quantitative determination of susceptibility to antifungal agents when testing Candida spp. directly from colonies grown on nonselective media.
Device Description
RPMI-1640 was developed by Moore et al. at Roswell Park Memorial Institute. The formulation is based on the RPMI- 1630 series of media utilizing a bicarbonate buffering system and alterations in the amounts of amino acids and vitamins. RPMI-1640 medium has demonstrated wide applicability in cell culture and also as the reference method for antifungal broth microdilution recommended by Clinical Laboratory Standards Institute (CLSI). When properly supplemented with MOPS, glucose, and agar RPMI-1640 has demonstrated accuracy for use with gradient-based systems with results comparable to that obtained with the CLSI reference method for testing Candida spp. against antifungal agents. The gradient method is based on a combination of the concepts of both dilution and diffusion tests, but differs from conventional disk methods by the use of a preformed, stable antibiotic gradient strip. When the strip is applied to the inoculated agar plate, there is an immediate release of the antibiotic into the agar matrix. A continuous and exponential gradient of antibiotic concentration is created beneath the carrier. After incubation a symmetrical inhibition ellipse centered along the carrier is seen. The zone edge intersects the strip at the minimum inhibitory concentration (MIC) value given in ug/ml. For antifungal testing, due to trailing effect, MICs should be read at approximately 90% inhibition of growth, ignoring faint hazes and minute colonies for flucytosine and 80% inhibition for fluconazole and itraconazole.
Ask a Question
Page 1 of 1