Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5130](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5130) → OBZ — Alpha-1-Antitrypsin Kit, Qualitative Phenotype

# OBZ · Alpha-1-Antitrypsin Kit, Qualitative Phenotype

_Immunology · 21 CFR 866.5130 · Class 2_

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

## Overview

- **Product Code:** OBZ
- **Device Name:** Alpha-1-Antitrypsin Kit, Qualitative Phenotype
- **Regulation:** [21 CFR 866.5130](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5130)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K213396](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/OBZ/K213396.md) | SPIFE A1AT kit | Helena Laboratories, Corp. | Oct 13, 2022 | SESE |
| [K063498](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/OBZ/K063498.md) | HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) | Sebia | Jun 11, 2007 | SESE |

## Top Applicants

- Helena Laboratories, Corp. — 1 clearance
- Sebia — 1 clearance

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

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