ABAXIS files 510(K) pre-market notification for Piccolo(TM) Blood Analyzer 12-test rotor.

SUNNYVALE, Calif.--(HealthWire)--Feb. 13, 1995--ABAXIS Inc. (NASDAQ/NMS:ABAX), a medical products company, Monday announced it has filed a 510(K) pre-market notification with the Food and Drug Administration (FDA) to market its 12-test General Health Panel Rotor to be used with the company's Piccolo(TM) Portable Blood Analyzer.

ABAXIS' 12-test rotor will provide to physicians fast, accurate, easy and economical near patient blood test results for the most frequently measured blood constituents used in medicine. The complete menu of tests can be performed in one step, using only a few drops of fingerstick blood with test results furnished on a printed card in less than 15 minutes.

ABAXIS believes that the Piccolo System and General Health Panel rotor could generate a large worldwide sales potential and contribute to more efficient and less expensive quality medical care.

"Our Piccolo System offers physicians worldwide immediate access to the most frequently requested blood chemistry tests without the need for a reference laboratory," said Gary Stroy, president and chief executive officer of ABAXIS.

"We believe that our system will positively contribute to more efficient and cost-effective medical care -- doctors will not have to wait hours or even days for the test results they need to make treatment decisions; routine blood testing will become as easy and reliable as measuring blood pressure or body temperature; and, highly trained or skilled personnel will not be required to obtain reliable results."

The 12-test rotor supplements the 9-test rotor which is currently awaiting FDA marketing clearance. "With 15 test methods now completed, we have the critical mass necessary to properly introduce our Piccolo System to the market," continued Stroy. "We have now accomplished more than 30 percent of our goal to offer the top 40-50 tests used in modern medicine, which constitutes 70 percent of the clinical tests ordered by physicians."

ABAXIS currently markets its blood analyzer to veterinarians under the name VetScan(TM). The same tests that are used in human medicine also are generally those used in veterinary medicine, although there may be slight alterations in the menu configuration. ABAXIS currently markets a 9-test rotor to the veterinary market and intends to introduce a 12-test and a thyroxine test during the course of the 1995 calendar year.

Founded in 1989, ABAXIS develops, manufactures and markets portable blood analysis systems for use in any patient-care setting to provide clinicians with rapid blood constituent measurements. The systems consist of a compact, 6.5 kilogram, portable analyzer and a series of 8 cm diameter single-use plastic disks, called reagent rotors, that contain all the reagents necessary to perform a fixed menu of tests.

The systems can be operated with minimal training and perform multiple routine tests on whole blood using either venous or fingerstick samples. The systems provide test results in less than 15 minutes with the precision and accuracy equivalent to a clinical laboratory.

The company currently markets the system to veterinarians under the name VetScan(TM) and is continuing to develop this system for introduction into the human market under the name Piccolo(TM).

CONTACT: ABAXIS Inc., Sunnyvale

Gary H. Stroy, 408/745-6854

or

Pondel Parsons & Wilkinson, Los Angeles 

Rob Whetstone, 310/207-9300