(143 days)
The Oxoid Dryspot E.coli 0157 test is a latex agglutination test for the identification of E.coli serogroup 0157 in colonies isolated from Sorbitol MacConkey (SMAC) Agar or SMAC Agar with Cefixime Tellurite Supplement. The test is not indicated for direct testing of faccal specimens.
latex agglutination test
This document is a 510(k) clearance letter from the FDA for a medical device, the Oxoid Dryspot E. coli 0157 Kit. It confirms that the device is substantially equivalent to a predicate device and can be marketed. However, this document primarily focuses on regulatory clearance and does not contain the detailed study information needed to describe acceptance criteria and device performance as requested.
Therefore, I cannot provide a complete answer to your request based solely on the provided text. The document does not include:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets, data provenance, or details about training sets.
- Information about expert qualifications, adjudication methods, or MRMC studies.
- Details on standalone performance or the type of ground truth used.
To answer your request, I would need access to the actual 510(k) submission document itself, which typically contains the technical and clinical data supporting the substantial equivalence claim. This clearance letter is merely the FDA's decision based on that submission.
§ 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.