(63 days)
The ESP Culture System II - Myco is an automated system for the growth and detection of -mycobacteria from human specimens, including the use of nucleic acid probes for the direct confirmation of positive ESP - myco bottles.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "ESP™ Culture System II - Myco/modification". This document does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and a study proving device performance.
This type of FDA letter confirms that a device is "substantially equivalent" to a predicate device already on the market, meaning it performs similarly and is as safe and effective. It does not typically include the detailed study methodology, acceptance criteria, or performance data that would be found in a clinical study report or the original 510(k) submission.
Therefore, I cannot provide the requested information based on the given text. The text mainly focuses on regulatory aspects, such as classification, general controls, and CLIA complexity categorization.
§ 866.2560 Microbial growth monitor.
(a)
Identification. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.