(51 days)
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Sulfisoxazole these include Enterobacteriaceae, and Staphylococcus spp. Sulpfisoxazole Susceptibility Test Discs are only used for testing urine samples.
Oxoid Sulfisoxazole Susceptibility Test Disc
The provided text is a 510(k) premarket notification letter from the FDA to Oxoid, Ltd. regarding their Sulfisoxazole Antimicrobial Susceptibility Test Disc. It confirms the device's substantial equivalence to a legally marketed predicate device. However, the document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or the full 510(k) submission. Therefore, I cannot extract the specific information requested in the prompt.
The document only states the device:
- Trade Name: Sulfisoxazole Antimicrobial Susceptibility Test Disc
- Regulatory Class: II
- Product Code: JTN
- Indication for Use: Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Sulfisoxazole these include Enterobacteriaceae, and Staphylococcus spp. Sulpfisoxazole Susceptibility Test Discs are only used for testing urine samples.
To provide the requested information, the full 510(k) submission document or a clinical study report for this device would be needed.
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).