Navigation Links
Announcing 510(k) Clearance of a New Microfluidic-based IVD Test System, the uTASWako® i30 Immunoanalyzer, and AFP-L3 and DCP Assays for Liver Cancer Risk Assessment.
Date:3/1/2011

RICHMOND, Va., March 1, 2011 /PRNewswire/ -- Wako Diagnostics, a division of Wako Chemicals USA, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the uTASWako i30 instrument with alpha-fetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP) in vitro diagnostic (IVD) tests in the USA.  The AFP-L3 and DCP assays are intended for use by healthcare professionals as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC).

(Logo:  http://photos.prnewswire.com/prnh/20110301/SF56416LOGO-a)

(Logo:  http://photos.prnewswire.com/prnh/20110301/SF56416LOGO-b)

"Wako is very pleased to receive 510(k) clearance for these assays using microfluidic technology," said Peter Panfili Ph.D., General Manager, Wako Diagnostics. "We expect that the adoption of these biomarkers into HCC surveillance programs will complement the use of imaging technologies to bring about the desired earlier detection and treatment of liver cancer."

HCC, primary liver cancer, is currently the fastest growing cause of cancer-related death in the USA. It has been demonstrated that HCC surveillance programs for at-risk patients improves applicability of curative therapies. Incorporating these biomarkers as additional surveillance tools will improve the chance of detecting early stage HCC and improve patient outcomes.

Microfluidics has enabled miniaturization and integration of key analyzer processes for the uTASWako i30: sampling, mixing, separation, and detection on microfluidic chips.  The system uses immunochemical and electrophoretic techniques to achieve rapid, accurate, precise and sensitive assay results.

As a bench top automated instrument, the uTASWako i30 is designed for efficiency and ease of use in a clinical chemistry setting.  Up to six analytes may be selected per patient sample with the first result reported in nine minutes. With automated calibration and quality control, the uTASWako i30 requires minimal setup time.  Reagent usage is tracked using radio frequency identification (RFID) tags.

The uTASWako i30 reports AFP-L3%, total AFP, and DCP values using Wako's unique reagents. This IVD test system is available to hospital laboratories, reference laboratories and tertiary care centers.  Wako is the only company that offers 510(k)-cleared AFP-L3 and DCP assays for IVD use.

About Wako Diagnostics

Wako Diagnostics, a division of Wako Chemicals USA, headquartered in Richmond, VA, is a solely owned subsidiary of Wako Pure Chemicals, with headquarters in Osaka, Japan. Wako Pure Chemicals offers a comprehensive range of reagents for both clinical and research laboratories, as well as specialty chemicals.  More information may be obtained at www.wakodiagnostics.com.


'/>"/>
SOURCE Wako Diagnostics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Announcing Companies to Present at the 7th Annual MidAmerica Healthcare Venture Forum
2. Announcing the Inaugural ACS Careers Virtual Career Fair in Conjunction with Informex and C&EN
3. BD Announces FDA 510(K) Submission of Rapid Molecular Test to Identify Patients Carrying Staph Superbug Prior to Surgery
4. Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k) Clearance
5. BD Announces FDA 510(k) Clearance of Two-Hour Test to Identify Superbug in Patients with Positive Blood Cultures
6. Kingfisher Announces FDA 510(k) Clearance of Breakthrough KFH Energy for Chronic Pain Sufferers
7. Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypass Surgery
8. AdvanDx Submits Yeast Traffic Light PNA FISH(TM) for FDA 510(k) Clearance for Detection of Candida species in Positive Blood Cultures
9. Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test
10. PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in Expanded Indications
11. Life Spine(R) Announces 510(k) Approval of SENTINEL(TM) OCT System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... 2016 Lianluo Smart Limited (Nasdaq: ... which develops, markets and sells medical devices and ... and international markets, recently attended the ... New Progress Forum, co-hosted by the Institute of ... , Guangdong Provincial People,s Hospital and Cardiology Department ...
(Date:12/2/2016)... 1, 2016 The concept of rare diseases and ... to this sector has been taking shape in ... political aspects and initiatives related to orphan medicinal products have ... level of member states individually. Many member states in the ... space of orphan medicinal products, the result of which took ...
(Date:12/2/2016)... Allergan plc (NYSE: AGN ), a ... previously announced Accelerated Share Repurchase (ASR) Program. Logo - ... ... previously announced, the Company entered into a variable tenor ASR ... repurchase $10 billion of its ordinary shares. Approximately 40.5 million ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... December 02, 2016 , ... U.S. Surgeon General, Dr. Vivek Murthy, ... Murthy explains how he was inspired to practice medicine at an early age by ... about more than making diagnoses and prescribing medicine,” he states. “It is about building ...
(Date:12/2/2016)... York, NY (PRWEB) , ... December 02, 2016 , ... ... high school and while 84 percent of parents report speaking with their child about ... pornography and sexually transmitted diseases. , Mediaplanet is proud to announce the launch of ...
(Date:12/2/2016)... ... December 02, 2016 , ... Universal Medical Systems, Inc. ... the first company to offer robotic imaging to veterinary medicine is sponsoring the ... 941 for the American Association of Equine Practitioners 62nd Annual Convention from December ...
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... "Pro3rd Accents ... FCPX editors to create versatile lower third titles with just a few clicks of ... Accents Volume 2 includes 30 lower third animations. Choose from various styles with accented ...
(Date:12/2/2016)... ... December 02, 2016 , ... ... Scientist & Author of Type 2 Diabetes: The Owner’s Manual, http://realtimepressrelease.com/press-releases-tagged-with/daryl-wein ... Kleyne Hour Power of Water, Global Climate Change and Your Health radio program ...
Breaking Medicine News(10 mins):