Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity

Regulations codified at 42 CFR 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578, require that the Secretary provide for the categorization of specific laboratory test systems, assays, and examinations by level of complexity. The criteria for such categorizations also are set forth in those regulations. A compiled list of approximately 12,000 specific clinical laboratory test systems, assays, and examinations categorized by level of complexity was published in the Federal Register on July 26, 1993 (58 FR 39860). This notice contains responses to the comments submitted on those aspects of the July 26, 1993 publication that were subject to comment. This Notice also announces approximately 2900 additional test systems, assays, and examinations that have been categorized since the publication of the compiled test list. Included in this list of additional categorizations are those test systems which received 510(k) or premarket approval from the Food and Drug Administration (FDA) during the period from September 1, 1992 to March 15, 1995. Also included are additional test systems that were cleared prior to that period and noted by commenters as missing from the compiled test list.