Bd Phoenix Automated Microiology System- Ertapenem 0.0625-8 Ug/Ml-Gn
by Becton, Dickinson and Company
510(k) K123266
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123266 | Date26 Jun 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LON
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1645
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The BD Phoenix Automated Microbiology System-Ertapenem 0.0625–8 µg/mL-GN is an automated antimicrobial susceptibility testing system designed for short-incubation identification and susceptibility testing of Gram-negative bacteria. It employs molded polystyrene panels containing dried ertapenem (0.0625–8 µg/mL) and fluorescent controls to detect bacterial resistance patterns.
The system operates by suspending pure culture colonies in broth, standardizing them via nephelometry, and inoculating them into the test panels. Supplied as a Class II medical device, it is intended for use in clinical microbiology laboratories and has received FDA 510(k) clearance under the Microbiology advisory committee. Panels are non-sterile and intended for single-use, with no MRI safety considerations specified.
From the manufacturer
The BD Phoenix™ automated identification and susceptibility testing system provides rapid, accurate and reliable detection of known and emerging antimicrobial resistance.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What types of bacteria is this system designed to test for susceptibility to ertapenem?
This system is specifically designed for short-incubation identification and susceptibility testing of Gram-negative bacteria. It uses molded polystyrene panels with dried ertapenem (0.0625–8 µg/mL) to detect resistance patterns in these bacterial types.
Are the test panels sterile, and how many times can they be used?
The test panels are non-sterile and intended for single-use only. They are not designed for reuse or reprocessing, ensuring accurate and consistent results for each test.
How is the inoculum prepared for testing on this system?
The system requires suspending pure culture colonies in broth, then standardizing the suspension via nephelometry before inoculating the test panels. This ensures proper bacterial concentration for accurate susceptibility testing.
What regulatory pathway was followed for FDA clearance of this device?
The BD Phoenix Automated Microbiology System-Ertapenem received FDA 510(k) clearance under the Microbiology advisory committee (MI). The submission was classified as substantially equivalent (SESE) and followed a traditional review pathway, with the decision based on the Microbiology product code (LON).
Does this system have any special handling requirements for storage or environmental conditions?
While specific storage conditions aren’t detailed in the data, the system is designed for use in clinical microbiology laboratories. Since the panels are non-sterile and single-use, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain integrity until use.