Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart E — Immunology Laboratory Equipment and Reagents](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents) → [21 CFR 866.4830](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/866.4830) → JZX — Equipment, Rocket Immunoelectrophoresis

# JZX · Equipment, Rocket Immunoelectrophoresis

_Immunology · 21 CFR 866.4830 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZX

## Overview

- **Product Code:** JZX
- **Device Name:** Equipment, Rocket Immunoelectrophoresis
- **Regulation:** [21 CFR 866.4830](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/866.4830)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

Rocket immunoelectrophoresis equipment for clinical use is a device used to perform a specific test on proteins by using a procedure called rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket-shaped pattern, giving the name to the device. The height of the peak (or the area under the peak) is proportional to the concentration of the protein.

## 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 § 866.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K930796](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZX/K930796.md) | ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS | Alko Diagnostic Corp. | Jan 13, 1994 | SESE |

## Top Applicants

- Alko Diagnostic Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZX](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZX)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com