21 CFR 862.1410 — Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1410
Identification
An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
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 |
|---|---|---|---|---|
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 | 21 | |
| JIY | Photometric Method, Iron (Non-Heme) | 1 | 67 | |
| JIZ | Atomic Absorption, Iron (Non-Heme) | 1 | 0 | |
| JJA | Radio-Labeled Iron Method, Iron (Non-Heme) | 1 | 4 |
