(64 days)
REMEL's Bile Esculin Azide Agar w/ 6 μg/ml Vancomycin is a plated medium recommended for use in qualitative procedures as a selective and differential medium for the primary isolation of vancomycin resistant enterococci from surveillance cultures. This product is not intended for use as method of antimicrobial susceptibility testing. Confirmation of vancomycin resistance by an approved method is recommended as some organisms on initial isolation may overoome the inhibitory effects of the medium.
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The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain any information about clinical study results, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on:
- Device Name: Remel Bile Esculin Azide Agar w/6 µg/ml Vancomycin
- Regulatory Class: II, Product Code: JSO
- Indications for Use: Plated medium for qualitative procedures, as a selective and differential medium for the primary isolation of vancomycin-resistant enterococci from surveillance cultures. It explicitly states it is not intended for antimicrobial susceptibility testing and recommends confirmation of vancomycin resistance by an approved method.
- FDA's determination: The device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the input text. The text does not describe a study that proves the device meets acceptance criteria, nor does it list any specific acceptance criteria or performance metrics.
§ 866.1700 Culture medium for antimicrobial susceptibility tests.
(a)
Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.(b)
Classification. Class II (performance standards).