21 CFR § 884.1550 - Amniotic fluid sampler (amniocentesis tray).

---
identifier: "/us/cfr/t21/s884.1550"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.1550 - Amniotic fluid sampler (amniocentesis tray)."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.1550"
section_name: "Amniotic fluid sampler (amniocentesis tray)."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 884.1550 Amniotic fluid sampler (amniocentesis tray).

(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.

(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.

[61 FR 1123, Jan. 16, 1996, as amended at 66 FR 33808, July 25, 2001]