TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

The TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge is an in vitro diagnostic device that measures blood clotting properties using thromboelastography. It analyzes 3.2% citrated whole blood samples through four independent assays (CK, CKH, CRT, CFF) to provide semi-quantitative parameters describing clot formation, speed, and strength. Results are used to assess hemostasis in cardiovascular surgery and cardiology procedures to evaluate hemorrhage or thrombosis risk.

The device uses optical detection of meniscus motion via a piezoelectric actuator vibrating measurement cells at multiple frequencies, with Fast Fourier Transform analysis to determine resonant frequency and clot elasticity. It maintains identical technological purpose, measurement technique, output format, physical configuration (vertically-oriented ring), signal generation and transduction, temperature control (20-50°C), sample volume (20 μL), and reagent composition compared to the predicate device. The only difference is expansion of the sample matrix to include both venous and arterial whole blood instead of venous only.

Not stated in this summary.

The submitter argues substantial equivalence based on: (1) identical technology, design, reported parameters, and mechanics with no additional product development required; (2) comprehensive comparison tables demonstrating all technological characteristics, clinical values, and operational parameters are the same; (3) non-clinical testing showing no statistical difference in agreement between TEG 6s and TEG 5000 by blood source, and predicated bias meeting clinically acceptable limits across all parameters; and (4) the only modification—adding arterial blood to the sample matrix—does not change the fundamental technology or intended use, with testing confirming equivalent performance between the modified device and predicate.