21 CFR 862.1320 — Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1320
Identification
A gastric acidity test system is a device intended to measure the acidity of gastric fluid. Measurements of gastric acidity are used in the diagnosis and treatment of patients with peptic ulcer, Zollinger-Ellison syndrome (peptic ulcer due to gastrin-secreting tumor of the pancreas), and related gastric disorders.
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 § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JLK | Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity | 1 | 0 | |
| JLL | Tubeless Analysis, Gastric Acidity | 1 | 0 |
