(11 days)
According to 21 CFR 866.2900, microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
The CytoQuant™ Chlamydia Transport Medium (2SP) is widely recognized as an effective medium for chlamydia transport
This document does not contain the requested information regarding the acceptance criteria and a detailed study proving the device meets those criteria. The provided text primarily focuses on safety precautions for handling the Chlamydia Transport Medium and states that "Proteins International conducts its own studies on each lot... using the following criteria: appearance, sterility, toxicity, and ability of the medium to maintain chlamydia viability over time." However, it does not provide the specific acceptance criteria for these characteristics, nor does it detail a study with the results of device performance against such criteria. The references cited are general and do not appear to be specific to a study validating this particular device.
Therefore, I cannot populate the table or answer the specific questions based on the provided text.
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).