(238 days)
Wellcolex E.coli 0157:H7 is a rapid latex agglutination test for the presumptive identification of Escherichia coli 0157:H7 isolates on laboratory media.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Wellcolex E.coli 0157:H7 - ZC61". It certifies that the device is substantially equivalent to a legally marketed predicate device. However, this letter does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes for training or test sets, expert qualifications, or adjudication methods.
Therefore, I cannot extract the requested information from this document. The letter only confirms that the device has been cleared for marketing based on its substantial equivalence to a predicate device for the presumptive identification of Escherichia coli O157:H7 isolates on laboratory media.
§ 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.