Section 880.2900 - Clinical color change thermometer(a)Identification. A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals.(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9 .45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38804 , July 25, 2001