21 CFR 876.1390 — Blood Detection Capsule
Gastroenterology, Urology (GU) · Subpart B—Diagnostic Devices · § 876.1390
Identification
An ingestible gastrointestinal blood detection capsule is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract. The Pill Sense System consists of a reusable receiver and a single-use ingestible capsule, intended to be used for the detection of blood in the upper gastrointestinal tract in hemodynamically stable adults suspected of having upper gastrointestinal bleeding (UGIB).
Classification Rationale
Class II (special controls). The device is granted under De Novo classification (21 CFR 876.1390) as the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QUD | Blood Detection Capsule | 2 | 1 |
Special Controls
QUD — Blood Detection Capsule
In combination with the general controls of the FD&C Act. the ingestible gastrointestinal blood detection capsule is subject to the following special controls:
De Novo Order DEN220065
