BBL Sceptor System Microdilution Antimicrobial Susceptibility

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Bbl Sceptor System Microdilution Antimicrobic Susc

Generic Name

SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

PMA Number

P800030 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

APPR Approved

PMA Supplement

S006

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• What is the primary purpose of the BBL Sceptor System Microdilution Antimicrobial Susceptibility in a clinical lab?

  The BBL Sceptor System is designed to automate antimicrobial susceptibility testing for microorganisms, including bacteria and fungi. It uses a microdilution method to determine how effectively antimicrobial agents work against specific isolates, helping labs quickly and accurately profile resistance patterns for better infection management and treatment decisions.

• Is the BBL Sceptor System reusable, and what precautions must be taken during use?

  Yes, the BBL Sceptor System is a reusable device. Since it involves handling microbial cultures, strict sterile techniques must be followed during preparation and handling of its components to prevent contamination and ensure accurate test results.

• How many model references are associated with this system, and what do they represent?

  The system includes multiple model references (listed as FEI numbers in the data), each corresponding to different configurations or variations of the BBL Sceptor System. These references reflect its adaptability for various antimicrobial susceptibility testing applications in microbiology labs.

• What regulatory pathway was followed for the approval of this device, and what does that mean for users?

  The BBL Sceptor System was authorized through an FDA Premarket Approval (PMA) process, specifically under PMA number P800030. This means the device underwent rigorous review to demonstrate safety and effectiveness for its intended use in antimicrobial susceptibility testing, providing users with confidence in its regulatory compliance and performance standards.