{"data":{"id":"us/21-cfr-866.5760","jurisdiction":"us","citation":"21 CFR 866.5760","heading":"Tryptase test system.","body":"(a) Identification. A tryptase test system is a device that aids in the diagnosis of systemic mastocytosis. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.\n(b) Classification. Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis.” For availability of the document, see § 866.1(e).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES","Subpart F—Immunological 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":"5c86f6c3d93f53501c5a041a17c6ce900da4d7fa4aef8bf25d619a2a826f3516","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5750","next":"us/21-cfr-866.5765"},"notice":"GroundRules: Original legal text. Not legal advice."}