{"data":{"id":"us/21-cfr-862.1450","jurisdiction":"us","citation":"21 CFR 862.1450","heading":"Lactic acid test system.","body":"(a) Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).\n(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 § 862.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES","Subpart B—Clinical Chemistry Test Systems"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"436cdd1bc2da24479cd22ff5cc983f3622879c92408a12357d97a9fdca843d60","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1445","next":"us/21-cfr-862.1455"},"notice":"GroundRules: Original legal text. Not legal advice."}