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) → PZH — Serpina1 Variant Detection System

# PZH · Serpina1 Variant Detection System

_Immunology · 21 CFR 866.5130 · Class 2_

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

## Overview

- **Product Code:** PZH
- **Device Name:** Serpina1 Variant Detection System
- **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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K211115](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/PZH/K211115.md) | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | May 13, 2021 | SESE |
| [K192858](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/PZH/K192858.md) | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | Nov 5, 2019 | SESE |
| [K171868](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/PZH/K171868.md) | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | Nov 11, 2017 | SESE |

## Top Applicants

- Progenika Biopharma S.A., A Grifols Company — 3 clearances

---

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

**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