ThromboLUX—In Vitro Diagnostic Use

ThromboLUX® is a quick and easy in-vitro diagnostic test intended to provide professionals with qualitative and quantitative information about microparticle content in platelet samples. Traditional methods of testing microparticles are not used routinely in clinical settings, because they are complex, time consuming and require many reagents and sample manipulations. ThromboLUX uses a non-invasive, easy-to-use optical test requiring only 100uL of sample, without the need for dilution or the addition of any reagents. It relies on the principle of dynamic light scattering to determine the size distribution and content of microparticles in a platelet sample.

General Specifications
24.5 cm (w) × 43.5 cm (h) × 34.2 cm (d) (9.8"x 17.1" x 13.5")
9.9 kg (22lb)
Colour LCD backlit 7" 800px X 480px
Operating temperature
23 ± 3°C (73.4°F ± 5.4°F)
Operating humidity
≤ 80% Relative Humidity (non-condensing)
Store at ambient temperature, in a clean, dust-free location, out of direct sunlight
Class 1
Input/Output terminals
Electrical Specifications
Input Voltage 100–240 VAC
Input Frequency
50–60 Hz
Power consumption
200 W
Standards compliance

FCC CFR47, Part 15, Subpart B
EN 61326 Class A
IEC 61010-1 Edition 2
IEC 60825-1:2007
EN 61000-3-2:2006
EN 61000-3-3:2008

Operational Specifications
Application Characterization of microparticle content in platelet samples
Test duration
5-6 minutes
Test article
Platelet samples, including donor samples and platelet concentrates

Gated MP Area (% intensity contribution)
Gated PLT Area (% intensity contribution)
ThromboLUX Score (0-40)
MP Factor (MP area/PLT area)
Peak MP Radius (nm)
Peak PLT Radius (nm)
Total Photon Count (kHz)
Data file (Tab delimited text)

Software TLUX_ARM

Honeywell MK9540-72A38 bar code scanner
USB 2.0 memory
ThromboLUX Test Kit
ThromboLUX Control Kit

ThromboLUX Console

Figure 4.2 ThromboLUX Console

Figure 4.2 ThromboLUX Console

ThromboLUX is currently available for sale as an in vitro diagnostic device in the United States and the European Union.