(129 days)
The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay for the qualitative detection of E. coli O157 in human feces. The test is designed to be used as an aid to the diagnosis of diarrhea caused by E. coli 0157 and as an adjunct to culture methodology.
The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay.
This document is a 510(k) clearance letter from the FDA for a medical device called the "Quix™ Rapid E. Coli 0157 Strip Test". It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter acknowledges receipt of the 510(k) notification and states that the device is deemed "substantially equivalent" to predicate devices, allowing its marketing. It outlines regulatory requirements but does not delve into performance testing details.
Therefore, I cannot extract the requested information the provided text.
§ 866.3255
Escherichia coli serological reagents.(a)
Identification. Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identifyEscherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist ofEscherichia coli antisera conjugated with a fluorescent dye used to identifyEscherichia coli directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium belonging to the genusEscherichia, and provides epidemiological information on diseases caused by this microorganism. AlthoughEscherichia coli constitutes the greater part of the microorganisms found in the intestinal tract in humans and is usually nonpathogenic, those strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.