Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5460](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5460) → DAB — Haptoglobin, Fitc, Antigen, Antiserum, Control

# DAB · Haptoglobin, Fitc, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5460 · Class 2_

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

## Overview

- **Product Code:** DAB
- **Device Name:** Haptoglobin, Fitc, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5460](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5460)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

## 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 |
| --- | --- | --- | --- | --- |
| [K913670](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAB/K913670.md) | HAPTOGLOBIN IMMUNOLOGICAL TEST KIT | The Binding Site, Ltd. | Dec 9, 1991 | SESE |
| [K843570](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAB/K843570.md) | FIAX HAPTOGLOBIN TEST KIT | Intl. Diagnostic Technology | Oct 5, 1984 | SESE |
| [K772078](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAB/K772078.md) | RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN | Gelman Instrument Co. | Feb 3, 1978 | SESE |

## Top Applicants

- The Binding Site, Ltd. — 1 clearance
- Intl. Diagnostic Technology — 1 clearance
- Gelman Instrument Co. — 1 clearance

---

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

**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