What types of instrumentation can manufacturers promote for use with LDTs?
ASRs are intended to be sold as building blocks for use in design of a diagnostic test by the test developer. If an ASR is promoted as being intended for use with a particular instrument, FDA would not view the promoted product as an ASR. Use of the ASR with the particular instrument would be a design choice by the ASR manufacturer and not by the test developer. As a result, manufacturers should not promote specific laboratory instruments for use in conjunction with particular ASRs. In contrast, open instruments that have user-defined capabilities, which allow the user to select an instrument and an ASR independently, and define, optimize, and validate the test performance characteristics and interpretation criteria, may be promoted for use generally in LDTs (e.g., spectrophotometers, HPLC). If instrumentation is used for an ASR-based test, the laboratory should be able to select the instrumentation and validate the performance of the LDT on that instrument.
