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# Haemonetics’ TEG 6s Analyzer Cleared for Trauma Setting
- URL: https://www.fdaweb.com/haemonetics-teg-6s-analyzer-cleared-for-trauma-setting/
- Published: 2019-05-14T12:00:00.000Z
- Updated: 2026-09-15T01:26:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144103

FDA has cleared a Haemonetics 510(k) to expand the medical indication of its [TEG 6s Hemostasis Analyzer System](https://c212.net/c/link/?t=0&l=en&o=2464595-1&h=957974498&u=http%3A%2F%2Fbit.ly%2F2UHhUI1&a=TEG%C2%AE+6s+Hemostasis+Analyzer+System&ref=fdaweb.com) for use in adult trauma settings. This clearance builds on the current indication for the TEG 6s system in cardiovascular surgery and cardiology procedures. Clearance was based on clinical data from a multicenter trial of about 500 adult patients comparing the TEG 5000 Hemostasis Analyzer System, which has been used in trauma for over a decade, to the next-generation TEG 6s system. “The study collected more than 150,000 data points and showed that the TEG 6s system is reliable, substantially and analytically equivalent and test results can be interpreted like those from the TEG 5000 system when used in a trauma setting,” the company says.

The device, which comprises an analyzer, disposable cartridges and software, is intended to provide rapid, comprehensive and accurate identification of a patient’s hemostasis condition. “Featuring an innovative, all-in-one cartridge, the TEG 6s system delivers viscoelastic test results without the complicated test preparation associated with traditional blood tests,” Haemonetics says. “The cartridge automatically mixes a small blood sample with reagents and runs up to four assays in parallel, lowering the potential for human error, allowing immediate test initiation and significantly reducing wait time for results so clinicians can quickly tailor treatment to a patient's specific needs.”