A comparison between the TEG 6s and TEG 5000 analyzers to assess coagulation in trauma patients

Abstract

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

TEG®6s system measures the contributions of both platelet count and platelet function to clot formation at the site-of-care

“…Comparisons to other whole-blood platelet function tests Multiplate® and VerifyNow® show TEG®6s is able to distinguish between healthy blood spiked with different concentrations of platelet inhibitor, with TEG®6s showing the best score for internal distribution of disagreement (5.0% for TEG®6s, 8.3% for VerifyNow® and 13.3% for Multiplate®) and lowest variability (5.1% for TEG®6s, 17.7% for VerifyNow® and 14.1% for Multiplate®) [20]. The TEG®6s is also smaller, more portable, and less sensitive to vibrations than previous models [9,21].…”

Diagnosis and Treatment of Trauma-Induced Coagulopathy by Viscoelastography

“…Although there is vigorous debate regarding the reproducibility of these VETs, for trauma patients who require massive transfusion with prohemostatic agents, these tests offer the same benefit in clinical outcomes as they have demonstrated for liver transplantations and the cardiac surgery patients. 119,120 With the evolution to a simplified tube or cartridge system and because of a new investigational cartridge system that can reliably predict DOAC activity, one can anticipate increased utilization of these tests at the site of care. Peripheral debates concerning the sensitivity of the VETs to guide the utilization of TXA in trauma do not detract from the welldesigned studies which show decreased mortality and blood utilization in those trauma patients whose resuscitation is guided by VETs.…”

Viscoelastic Hemostatic Assays: Moving from the Laboratory to the Site of Care—A Review of Established and Emerging Technologies

“…The TEG ® 6s system has gained regulatory clearance in the USA and Europe amongst other international markets and has been compared to first-generation thromboelastography systems in the literature [19,[21][22][23]. The assays available with the TEG ® 6s are similar to the TEG ® 5000 and are available in three cartridge configurations.…”

“…Furthermore, unlike many of the first-generation devices that had significant inter-laboratory variance, with coefficients of variation >10% [18][19][20], these newer-generation devices have demonstrated reduced variance [21]. Whilst older-generation devices enabled users to focus on running channels of interest, newer devices detailed below require users to run entire cartridges.…”

“…Diagnostics 2020, 10, x FOR PEER REVIEW 8 of 14 the literature[19,[21][22][23]. The assays available with the TEG ® 6s are similar to the TEG ® 5000 and are available in three cartridge configurations.…”