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 contains four independent assays (CK, CKH, CRT, CFF) that monitor different aspects of coagulation in 3.2% citrated whole blood samples and can be used in clinical laboratories or at the point-of-care to assess hemostasis before, during, and after cardiovascular procedures.

The device uses optical detection of meniscus motion in a vertically-oriented ring containing the blood sample. A piezoelectric actuator vibrates the measurement cell through multi-frequency sinusoids, and resonant frequency changes are tracked via photodiode detection and Fast Fourier Transform analysis. The technology is identical to the predicate in measurement principle, sample volume (20 μL), temperature control (20–50°C), analyzer hardware design, and all four assays with their respective reagents and reported parameters.

IEC 61010-1, IEC 61010-2-010, IEC 61010-2-101 (electrical safety); IEC 60601-1-2, IEC/EN61326-1, IEC/EN61326-2-6 (electromagnetic compatibility).

The modified device is substantially equivalent to the predicate (K150041) because there is no change to the underlying technology, design, reported parameters, measurement technique, or mechanics of cartridge operation on the TEG 6s analyzer. The only difference is that the indications for use now explicitly include point-of-care use in addition to clinical laboratory use, which represents a location of use expansion rather than a technological change. All technological characteristics—from signal generation and transduction to sample preparation, assays, and quality controls—remain identical to the predicate device.