(a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a device that measures the degree of sedimentation taking place in a given length of time. An increased rate indicates tissue damage or inflammation.

(b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.