Below is the classifcation rule. Note that this has been used for automated sample preparation systems of some types as well.TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 862_CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES–Table of Contents
Subpart C_Clinical Laboratory Instruments
Sec. 862.2050 General purpose laboratory equipment labeled or promoted
for a specific medical use.
(a) Identification. General purpose laboratory equipment labeled or
promoted for a specific medical use is a device that is intended to
prepare or examine specimens from the human body and that is labeled or
promoted for a specific medical use.
(b) Classification. Class I (general controls). The device is
identified in paragraph (a) of this section and is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9. The device is also
exempt from the current good manufacturing practice regulations in part
820 of this chapter, with the exception of Sec. 820.180, with respect
to general requirements concerning records, and Sec. 820.198, with respect to complaint files.
[52 FR 16122, May 1, 1987, as amended at 66 FR 38788, July 25, 2001]