Sterile Cleocin Susceptibility Pwd (Clindamycin)

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Susceptibility test powders, antimicrobial

PMA Number

N50163 ↗

FDA Product Code

JTT

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

APRL

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See all devices from The Upjohn Co. →

• What is the STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN) used for in a clinical setting?

  This device is an antimicrobial susceptibility test powder used exclusively for in vitro testing. It helps determine whether bacterial isolates are susceptible or resistant to clindamycin, which guides clinicians in selecting appropriate antimicrobial therapy for infections. The results assist in making evidence-based decisions to improve patient outcomes by ensuring the right antibiotic is prescribed.

• How is the STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN) supplied and intended for use?

  The powder is supplied in a sterile form, ensuring it is ready for immediate use without additional sterilization. It is designed for single-use only in microbiology laboratories, meaning each package should be discarded after one test to maintain accuracy and prevent contamination. This aligns with standard microbiological practices for susceptibility testing.

• Is this device reusable, or is it meant for one-time use?

  This device is explicitly intended for single-use only. Since it is a sterile susceptibility test powder, reusing it could compromise the integrity of the test results due to potential contamination or degradation of the antimicrobial agent. Laboratories must adhere to this guideline to ensure reliable and accurate bacterial susceptibility testing.

• What regulatory pathway does the STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN) follow, and what does that mean for its use?

  The device follows the FDA’s Premarket Approval (PMA) pathway, as indicated by the PMA number N50163. This means it has undergone rigorous review by the FDA’s Microbiology Advisory Committee (MI) to ensure its safety and effectiveness for its intended use in testing bacterial susceptibility to clindamycin. Clinicians and labs can rely on its regulatory approval for clinical decision-making.

• How should the STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN) be stored, and why is this important?

  While the exact storage conditions aren’t detailed in the provided data, standard microbiological practices must be followed to maintain its integrity. Since it is sterile and used for critical diagnostic testing, improper storage—such as exposure to moisture, extreme temperatures, or contamination—could compromise its effectiveness. Adhering to these guidelines ensures accurate and reliable susceptibility testing results for patient care.