Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5490](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5490) → CZX — Hemopexin, Antigen, Antiserum, Control

# CZX · Hemopexin, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5490 · Class 2_

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

## Overview

- **Product Code:** CZX
- **Device Name:** Hemopexin, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5490](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5490)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A hemopexin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the hemopexin (a serum protein that binds heme, a component of hemoglobin) in serum. Measurement of hemopexin aids in the diagnosis of various hematologic disorders, such as hemolytic anemia (anemia due to shortened in vivo survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia.

## 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 § 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 § 866.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K801432](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZX/K801432.md) | HEMOPEXIN NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | Jul 8, 1980 | SESE |
| [K790713](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZX/K790713.md) | ANTISERUM TO HUMAN HEMOPEXIN | Kent Laboratories, Inc. | Sep 4, 1979 | SESE |
| [K780250](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZX/K780250.md) | HEMOPEXIN NEPHELOMETRIC ASSAYS | Kallestad Laboratories, Inc. | Feb 28, 1978 | SESE |

## Top Applicants

- Kent Laboratories, Inc. — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
- J.T. Baker Chemical Co. — 1 clearance

---

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

**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