{"data":{"id":"us/21-cfr-884.1550","jurisdiction":"us","citation":"21 CFR 884.1550","heading":"Amniotic fluid sampler (amniocentesis tray).","body":"(a) Identification. The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.\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 the limitations in § 884.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES","Subpart B—Obstetrical and Gynecological Diagnostic Devices"],"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":"92d4039af351207a67c844e62d07580cb98c71e109eea0f037cc9aed0d3964c2","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.1425","next":"us/21-cfr-884.1560"},"notice":"GroundRules: Original legal text. Not legal advice."}