---
kind: "section"
citation: "21 C.F.R. § 884.1550"
title: "21"
number: "884.1550"
heading: "Amniotic fluid sampler (amniocentesis tray)."
url: "https://uscodex.org/cfr/21/884.1550"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 884.9](/cfr/21/884.9.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

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