Code of Federal Regulations Title 42. Public Health § 42.493.1253 Standard:  Establishment and verification of performance specifications

(b)(1) Verification of performance specifications. Each laboratory that introduces an unmodified, FDA–cleared or approved test system must do the following before reporting patient test results:

(2) Establishment of performance specifications. Each laboratory that modifies an FDA–cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable:

(3) Determination of calibration and control procedures. The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section.