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October 28, 2005 | Customer News

Tecan’s Freedom EVOlyzer® clears review from the FDA

Tecan’s Freedom EVOlyzer® family of powerful, fully automated microplate analyzers was recently submitted to the Food and Drug Administration for 510(k) clearance and was determined to be Class I exempt for its current intended use under the FDA regulation 21 CFR part 862 for clinical laboratory instruments. The open system, available in three different worktable sizes, already complies with the European Community IVD-Directive 98/79/EC and is suitable for a range of throughputs, featuring customizable workspaces that can be adapted to the requirements of many commercial EIA processing assays.

Each system achieves high-speed serial and parallel pipetting using a two, four- or eight-tip liquid handling arm and microplates are effortlessly moved around the workspace by a robotic manipulator arm. All washing and reading steps are fully automated using a Columbus™ Washer and the highly acclaimed Sunrise™ Reader.

The Freedom EVOlyzer combines all the traditional benefits of Tecan’s automation platforms with extra safety features, including larger safety panels and automatic door locks, positive bar code identification of samples, reagents and plates, and restricted access. In addition, its current state-of-the-art software and touch screen operation make the system very easy to use. Every action made by a user and every process on the instrument is continually monitored and controlled, making the Freedom EVOlyzer the ideal efficient solution to automate EIA processing.

About Tecan

Tecan (www.tecan.com) is a leading player in the Life Sciences supply industry that specializes in the development, production, and distribution of solutions enabling the discovery of pharmaceutical substances, as well as for genomics, proteomics, and diagnostics. Through its subsidiary REMP (www.remp.com) Tecan is a leading supplier of compound and sample storage, managerial and logistic solutions. Tecan clients are leading pharmaceutical and biotechnology companies, university research departments and diagnostic laboratories. Founded in Switzerland in 1980, the company has manufacturing, research and development sites in both North America and Europe and maintains a sales and service network in 52 countries. In 2004, Tecan achieved sales of CH 286.0 million (USD 230.6 million; EUR 185.7 million). Registered shares of Tecan Group are traded on the SWX Swiss Exchange (TK: TECN / Reuters: TECZn.S / Valor: 1210019).

For further information please contact:

Tecan Switzerland AG
Seestrasse 103
CH-8708 Männedorf

T +41 44 922 81 11
F +41 44 922 81 12
www.tecan.com



2014-02-18: Corrigendum of the press release d.d. 28 October 2005:

“Tecan’s Freedom EVOlyzer® family of powerful, fully automated microplate analyzers was recently submitted to the Food and Drug Administration for 510(k) clearance and was determined to be Class I exempt for its current intended use under the FDA regulation 21 CFR part 862 for clinical laboratory instruments.”

Is replaced by: “Tecan’s Freedom EVOlyzer® family of powerful, fully automated microplate analyzers was determined to be Class I, 510(k) exempt for its current intended use under the FDA regulation 21 CFR part 862 for clinical laboratory instruments.”