Synergies Plus Gram-Positive MIC/Combo Panels
by Dade Behring, Inc. 510(k)
Active
510(k) K071076
Overview
The MicroScan Synergies Plus Gram-Positive MIC/Combo Panel is a device used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci. The panels contain dehydrated antibiotics and control wells that are rehydrated with 0.1 mL of turbidity-prepared inoculum (3-7 x 10⁵ CFU/mL).
After inoculation, panels are incubated for 4.5-18 hours at 35°C ± 1°C in a WalkAway system, where an optical system uses colorimetric light detection to monitor growth. The device is intended for in vitro diagnostic use and has received FDA 510(k) clearance with the product code LON. It is supplied as a panel for laboratory use and requires appropriate laboratory equipment for operation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071076 | Date21 May 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
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
Other devices from Dade Behring, Inc.
Questions
What is the purpose of the Synergies Plus Gram-Positive MIC/Combo Panels?
The MicroScan Synergies Plus Gram-Positive MIC/Combo Panels are used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci.
How are the Synergies Plus panels supplied and what equipment is required?
The panels are supplied as laboratory panels that contain dehydrated antibiotics and control wells. They require appropriate laboratory equipment for operation, including a WalkAway system for incubation at 35°C ± 1°C and an optical system for colorimetric light detection to monitor growth.
What is the regulatory status of the Synergies Plus Gram-Positive MIC/Combo Panels?
The device is intended for in vitro diagnostic use and has received FDA 510(k) clearance with the product code LON. It is substantially equivalent to other devices in this category and was reviewed by the Microbiology advisory committee.
How long does the testing process take with the Synergies Plus panels?
After inoculation, the panels are incubated for 4.5-18 hours at 35°C ± 1°C in a WalkAway system. This incubation period allows for sufficient growth detection through the optical system's colorimetric light detection method.