Sunquest Receives FDA Clearance for Blood Bank Software

The U.S. Food and Drug Administration (FDA) has granted Sunquest Information Systems Inc. (Tucson, AZ) clearance to market its Flexilab Blood Bank and Blood Donor version 5.2 systems.

This clearance removes previously imposed FDA marketing restrictions for the promotion, sale, and new installations of the product on both the IBM AIX platform and the Compaq (DEC) UNIX platform.

This blood bank software module, sold in various versions since 1982, is an optional component of FlexiLab, the company's laboratory information system.

In March 1994, FDA determined that blood bank software was a medical device under the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. Blood bank software manufacturers were notified of this change and required to submit either a premarket approval application or a premarket notification under Section 510(k) of the Act.

Sunquest submitted a 510(k) notification regarding the module in 1996, and submitted a new 510(k) notification in January 1999. On Thursday, Aug. 19, 1999, the company received word that FDA has cleared version 5.2 of the blood bank product on both the IBM AIX and the Compaq (DEC) UNIX platforms for marketing and distribution.

The company will resume marketing and distribution of this product, having suspended sales, promotions, and new installations of the product in early 1999 to comply with FDA regulations.