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The provided document is a 510(k) clearance letter from the FDA for the "Gram-Negative QuickFISH™ BC Blood Culture Identification Kit." This letter grants market clearance based on substantial equivalence to a predicate device, but it does not contain the detailed study information, acceptance criteria, or performance data typically found in the 510(k) submission itself.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, ground truth methods), or the specifics of standalone or MRMC studies from this document.
To answer your questions, I would need access to the actual 510(k) submission for K123418, which would include the clinical and analytical study reports.
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(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 § 866.9.