(67 days)
The ImmunoCard STAT! E.coli O157 Plus is a rapid test for the detection of antigens from shiga toxin producing E.coli O157 as an aid in the diagnosis of E.coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "ImmunoCard STAT! E.coli 0157 Plus" device. It does not contain information regarding
acceptance criteria, study design, sample sizes, expert qualifications, or ground truth
details. Therefore, I cannot provide the requested information based on the input 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.