21 CFR 884.1550 — Sampler, Amniotic Fluid (Amniocentesis Tray)

Obstetrics/Gynecology (OB) · Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices · § 884.1550

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.

Classification Rationale

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.

Product Codes