Ceftriaxone 30 Mcg Sensi-Disc

• • Ongoing Z-1024-2024 FDA Class II ·initiated 8 Jan 2024

  There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

510(k) Number

K850358 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

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  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

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  FDA 510(k) K915478 Active Cleared 27 Jan 1992

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  FDA 510(k) K844645 Active Cleared 5 Mar 1985

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  FDA 510(k) K771582 Active Cleared 13 Sep 1977

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  FDA 510(k) K802136 Active Cleared 10 Oct 1980

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• What is the Ceftriaxone 30 Mcg Sensi-Disc used for in a clinical setting?

  The Ceftriaxone 30 Mcg Sensi-Disc is specifically designed for disk diffusion testing (Kirby-Bauer method) in microbiology laboratories. It helps determine whether bacteria are susceptible or resistant to ceftriaxone, a third-generation cephalosporin antibiotic, by measuring the zone of inhibition around the disc on inoculated agar plates. This aids clinicians in selecting appropriate antibiotic treatments.

• How is the Ceftriaxone 30 Mcg Sensi-Disc supplied, and is it reusable?

  The discs are supplied in sterile, single-use cartridges, each containing 50 spring-loaded discs for precise dispensing. The spring mechanism ensures accurate placement on agar plates, and the sterile packaging prevents contamination. Since they are single-use, they must not be reused to maintain reliability and sterility.

• What storage and handling precautions should be taken for this antimicrobial susceptibility test disc?

  The discs must be stored and handled according to standard microbiological practices to preserve sterility and accuracy. This includes keeping them in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use. Improper storage could compromise the disc’s effectiveness in testing bacterial susceptibility.

• Are there different sizes or models of this disc available, and how do I identify the correct one?

  This product is specifically the 30 mcg Ceftriaxone Sensi-Disc, and no other sizes or models are mentioned in the specifications. The 30 mcg concentration is standardized for testing bacterial susceptibility to ceftriaxone. Always verify the label or packaging to confirm the correct disc type before use, as incorrect concentrations could lead to inaccurate results.