21 C.F.R. § 884.1550

Amniotic fluid sampler (amniocentesis tray)

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(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]

Notes of Decisions

Cited in 1 case, 1994–1994 · leading case: United States v. An Undetermined No. of Unlabeled Cases, Etc., Clinical Reference Lab'y, Inc., Claimant-Appellant, 21 F.3d 1026 (10th Cir. 1994).

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United States v. An Undetermined No. of Unlabeled Cases, Etc., Clinical Reference Lab'y, Inc., Claimant-Appellant, 21 F.3d 1026 (10th Cir. 1994). “21 C.F.R. § 884.1550 . The FDA can reclassify a device already in distribution as class III for purposes of a new intended use.”

Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.