PanNAT system | Micronics, Inc. | WMD Detector Selector

General Description
The PanNAT system is a sample-to-solution, man-portable, PCR-based instrument that is mains and/or battery powered, lightweight and WiFi-enabled. It processes a microfluidics-enabled cartridge into which all reagents are integrated for extraction, amplification and detection of multiple targets from a single sample. Waste is captured on cartridge. Designed for lowest cost, the system employs molecular beacon probe technology and BTI dyes and quenchers together with Micronics’ novel heating and cooling method for end point detection. It is real time capable. The system is designed for use at ambient temp; no refrigeration is required. The system is designed to meet the FDA’s 510(k) Class II device and CLIA Waiver guidelines.

Technical Description
Microfluidics-enabled sample processing of all nucleic acid assay steps with reagents integrated into the disposable cartridge for multiplex end point polymerase chain reaction detection in a man-portable point of care instrument. Novel heating and cooling platform and lowest cost fluorescent detection.

Evaluation Criteria

THROUGHPUT:

Between 30 and 60 minutes for detection
1 sample, >10 tests/sample per run
Less than 32 samples every 2 hours
The system or device is currently fully automated
Device or system is intended for multiple detection assays
4 solutions, buffer, eluents, and/or reagents
1 component
Less than 5 minutes is required for setup
1-2 steps are required for detection

LOGISTICS:

Very brief (minutes-hours) training and minimal technical skills
Approximately the size of a toaster
Between 1 and 5 kg
Wireless and wired connections are available
System or device uses batteries
4-8 hours battery life

OPERATIONS:

Can be used from 4°C to 41°C
Components must be stored at room temperature (27°C)
Performance is not influenced by relative humidity
Between 1 to 3 years shelf life
Results cannot be viewed in real-time
The system is not capable of autonomy
The system software is open but modification requires licensing
The system hardware is closed and not available for modification

DETECTION:

Possible the system could receive 510K clearance, no current efforts at this time
Possible the system could receive FDA approval, no current efforts at this time
Less than 250 µL
Excellent specificity. System has occasional false alarms under certain conditions (<2%)
100-1,000 CFU per mL
100-1,000 PFU per mL

Tier Selection