(59 days)
The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for caspofungin in the dilution range of 0.008 - 16ug/ml for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of caspofungin is for: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis
Not Found
This is an FDA Premarket Notification (510(k)) summary for the Sensititre® YeastOne® Susceptibility System with Caspofungin. The document does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The provided text only includes:
- A formal letter from the FDA affirming substantial equivalence for the device.
- The indications for use for the device, which specify "clinical susceptibility testing of Candida spp." with a caspofungin dilution range for specific Candida species.
Therefore, I cannot provide the requested information based on the given input.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).