Quantra QStat Cartridge

The QStat Cartridge is a single-use, multi-channel disposable cartridge used with the Quantra Hemostasis Analyzer to measure whole blood viscoelastic properties and assess coagulation status. It is indicated for in vitro diagnostic use in patients 18 years and older to evaluate blood coagulation and clot lysis in trauma, liver transplantation, and peripartum obstetric procedures, providing measurements of clot time, clot stiffness, fibrinogen contribution, platelet contribution, and clot stability to lysis.

The device uses the same SEER Sonorheometry proprietary technology, identical hardware (Quantra Hemostasis Analyzer HS-002), identical reagent formulations across all four channels, the same software version 2.4.1, and produces the same five output parameters (CT, CS, FCS, PCS, CSL). The only difference from the predicate is the addition of peripartum obstetric patients to the indications for use; all technical specifications and measurement methodology remain unchanged.

Not stated in this summary.

Substantial equivalence is established because the modified device is identical to the predicate in all technological characteristics—same manufacturer, hardware, software, reagents, methodology, and test outputs. The only modification is a labeling change to include peripartum obstetric patients. This population expansion is supported by analytical specificity testing showing no interference from obstetric medications (hemabate, methergine, misoprostol, oxytocin) and clinical performance data from 322 parturients demonstrating 92% agreement with ROTEM delta for lysis detection and good correlation with fibrinogen levels (r=0.815).