---
kind: "section"
citation: "21 C.F.R. § 876.1390"
title: "21"
number: "876.1390"
heading: "Ingestible gastrointestinal blood detection capsule."
url: "https://uscodex.org/cfr/21/876.1390"
---

# §876.1390. Ingestible gastrointestinal blood detection capsule.

- (a) **Identification.** An ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must evaluate:
    - (i) Detection of presence or absence of blood when compared to endoscopic procedures used to detect upper gastrointestinal bleeding;
    - (ii) Capsule excretion and recovery; and
    - (iii) **All adverse events.**
  - (2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
    - (i) Dimensional testing must verify device dimensions;
    - (ii) Performance testing must verify functional aspects of the device design;
    - (iii) Battery life testing must be performed to demonstrate the capsule's operating time is not constrained by the battery capacity;
    - (iv) Leak testing must verify device integrity under worst-case clinical conditions;
    - (v) Bite testing must demonstrate that the device can withstand bite forces;
    - (vi) pH resistance testing must evaluate integrity of the capsule when exposed to a physiological relevant range of pH values;
    - (vii) Control and monitoring of capsule bioburden must demonstrate the device does not pose an infection risk; and
    - (viii) Blood detection testing must demonstrate that the device can detect different forms of blood seen under anticipated conditions of use.
  - (3) Software validation, verification, and hazard analysis must be performed.
  - (4) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed.
  - (5) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
  - (6) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (7) Performance testing must support the shelf life of the device by demonstrating continued package integrity and device functionality over the identified shelf life.
  - (8) Physician labeling must include:
    - (i) A detailed summary of the clinical testing pertinent to use of the device, including information on effectiveness and device- and procedure-related complications;
    - (ii) Warning that the device is not a standalone diagnostic device and does not replace clinical decision making; and
    - (iii) **A shelf life.**
  - (9) Patient labeling must include:
    - (i) An explanation of the device and the mechanism of operation;
    - (ii) The patient preparation procedure;
    - (iii) A brief summary of the clinical study; and
    - (iv) **A summary of the device- and procedure-related complications pertinent to use of the device.**

## Notes

### Amendments

[91 FR 36521, June 17, 2026]

### Authority

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

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[91 FR 36521, June 17, 2026]