DeviceClearance

Product code PZH— Immunology

A1AT Genotyping Test

Classification name
Serpina1 Variant Detection System
Device class
Class 2
Regulation
21 CFR 866.5130
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

FDA classification definition

“This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. This assessment system provides users with genetic information regarding genotypes of SERPINA1 allelic variants and is intended to be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of individuals with A1AT deficiency.”

— U.S. Food and Drug Administration, device classification record for product code PZH under 21 CFR 866.5130, via openFDA

Market context for product code PZH

FDA has cleared 3 devices under product code PZH between 2017 and 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PZH

Recent clearances under product code PZH

Data sourced from openFDA. This site is unofficial and independent of the FDA.