# K050596: Quantia A1-at

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: May 13, 2005 after 66 days
- Product code: DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860894 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 1.

## Indications for use
The Quantia Al-AT is intended for the in vitro quantitative determination of alpha-l-antitrypsin concentration in human serum or plasma (hepariR with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema. Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Al-AT reagents by turbidimetry. (NOTE: This control has been also FDA 510(k) submitted for use with Quantia Beta-2 Microglobulin). For in vitro diagnostic use. Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia Al-AT reagents by turbidimetry. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K050596
Methodology: https://510kreport.com/methodology