General Description
The Bio-Plex 200 System is a laboratory analysis tool designed for protein detection and analysis using immunoassay xMAP technology.
Technical Description
The Bio-Plex 200 system is based on xMAP technology, a proprietary technology that color codes beads which are then used in sandwich immunoassay analysis. These assays are multiplexable.
Notes:
xMap technology also used on Luminex MAGPIX device.
Evaluation Criteria
THROUGHPUT:
- Between 60 minutes and 8 hours for detection
- Multiple samples, multiple tests/sample per run
- 49-96 samples every 2 hours
- The system or device is currently fully automated
- Device or system is intended for multiple detection assays
- 5 or more components
- Greater than 20 minutes is required for set-up
- 3-5 steps are required for detection
LOGISTICS:
- A day of training and technical skills are required
- Approximately the size of a carry-on luggage suitcase
- Between 25 and 50 kg
- Wireless and wired connections are available
- System or device has 110V electrical requirement
OPERATIONS:
- Can be used from 25°C to 37°C
- Components must be stored at 4°C
- Between 1 to 3 years shelf life
- Greater than 10 years expected life
- Results can be viewed in real-time
- The system could be adapted to a fully autonomous system with some effort
- The system software is closed and not available for modification
- The system hardware is closed and not available for modification
DETECTION:
- Not possible for the system to achieve 510K clearance
- Not possible for the system to achieve FDA approval
- Less than 50 µL