(60 days)
The Sensititie 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the elimination of limitations in the sensititre technical insert. The limitation to be removed are as follows: - 1) The AutoReader system should not be used to read coagulase-negative Staphylococcus Species as they will not generate adequate signal to give a susceptibility result. Such strains should be read manually. Maintain limitation 8 with a modification: Staphylococcus Species - tested against Penicillin G. Should also be tested for Beta lactamase production, especially in strains with borderline MIC's (0.06 -- 0.25 µg/ml). If these strains test Beta Lactamase positive a repeat test should be done to ensure resistance is reported. The addition of the following limitation in the Sensititre Technical Insert: The Autoreader system should not be used to read SXT with CNS. SXT should be read manually.
Susceptibility Test Panel
This is a 510(k) premarket notification for a Susceptibility Test Panel, which is an in vitro diagnostic product. The document does not contain the detailed study information required to fill out the table regarding acceptance criteria and performance, as it is a regulatory letter rather than a clinical study report. It primarily discusses the regulatory review and approval of the device, along with proposed changes to its labeling and limitations for use.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth details from the provided text. This information is typically found in a clinical or validation study report, which is not present here.
§ 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).