saliva drug screening device submission

ASX Company Announcement
24 October 2007
Harrington
Group Limited
ABN 18 001 285 230
Suite 401, 480 Collins Street, Melbourne Victoria 3000
T: +61 3 8610 6370 | F: +61 3 8610 6374 | E: [email protected]
ASX: HGR
www.hgrltd.com
HARRINGTON GROUP
ADVISES OF FILING OF 510(k) SUBMISSION FOR THE
COMPANYS’ SALIVA DRUG SCREENING DEVICE ORALINE
The Company advises that having completed the necessary studies the Company’s subsidiary
Sun Biomedical Laboratories (SBL) has filed for US Food and Drug Administration (FDA)
510(k) clearance for the Company’s saliva illicit drug screening device OraLine.
The Company will resume selling Oraline into the US workplace testing market once 510(k)
clearance has been received from the FDA. The product is presently marketing for forensic
use.
The Company is the first organisation to file for a multi drug 510(k) clearance on a saliva
illicit drug testing device and is optimistic subject to FDA review that clearance could be
achieved within the first quarter of calendar year 2008. With no saliva tests having attained
510(k) clearance, the Company views the matter of compliance with FDA guidelines as a
strategic imperative that will provide a significant competitive advantage in the U.S. market.
All available resources are focused on delivering 510(k) clearance in the shortest practical
timeframe.
For further information see www.hgrltd.com or contact: