Guidance for Industry: 'Computer Crossmatch' (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Reciipient's Serum or Plasma Type)

摘要

Computer crossmatch is a process used to ensure that blood released for transfusion is compatible with the intended recipient. We, FDA, are issuing this guidance to assist you, blood establishments that perform compatibility testing using a computer crossmatch system to perform computerized matching of blood, consistent with current good manufacturing practice (CGMP) requirements in 21 CFR Parts 210, 211 and 606. Blood establishments must have standard operating procedures (SOPs) to demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type under the compatibility testing requirements in 21 CFR 606.151(c). This guidance describes practices that we believe satisfy the requirements in 21 CFR 606.151(c) to help ensure detection of an incompatible crossmatch when using a computerized system for matching a donor's cell type with a recipient's serum or plasma type.