---
kind: "section"
citation: "21 C.F.R. § 868.1170"
title: "21"
number: "868.1170"
heading: "Indwelling blood hydrogen ion concentration (pH) analyzer."
url: "https://uscodex.org/cfr/21/868.1170"
---

# §868.1170. Indwelling blood hydrogen ion concentration (pH) analyzer.

- (a) **Identification.** An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.
- (b) **Classification.** Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

## Notes

### Amendments

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001]

### Authority

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

### Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.

### Amendments

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001]