Section 862.1305 - Formiminoglutamic acid (FIGLU) test system(a)Identification. A formiminoglutamic acid (FIGLU) test system is a device intended to measure formiminolutamic acid in urine. FIGLU measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic anemia.(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 § 862.9 .52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787 , July 25, 2001