Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5210](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5210) → JFR — Indirect Copper Assay, Ceruloplasmin

# JFR · Indirect Copper Assay, Ceruloplasmin

_Immunology · 21 CFR 866.5210 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JFR

## Overview

- **Product Code:** JFR
- **Device Name:** Indirect Copper Assay, Ceruloplasmin
- **Regulation:** [21 CFR 866.5210](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5210)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K051456](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JFR/K051456.md) | SENTINEL CERULOPLASMIN | Sentinel Ch. Srl | Oct 21, 2005 | SESE |
| [K882622](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JFR/K882622.md) | CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | Jul 8, 1988 | SESE |

## Top Applicants

- Technicon Instruments Corp. — 1 clearance
- Sentinel Ch. Srl — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JFR](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JFR)

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