# K053072: N Antisera to Human ALPHA1-Antitrypsin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 28, 2006 after 147 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.
8 later devices descend from it; 2 cite it directly.
0 of 10 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.

## Most influential descendants
- K063663: Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H (2007), 6 descendants of its own
- K072435: Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H (2007), 4 descendants of its own
- K071980: Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,H (2007), 2 descendants of its own
- K083445: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LC (2009), 1 descendant of its own
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator (2008), 1 descendant of its own

## Indications for use
In vitro diagnostic reagents for the quantitative determination of ao-antitrypsin in human serum, heparinized and EDTA plasma by means of immunonephelometery on the BNTM Systems. The measurement of a 1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, al-antitrypsin deficiency has been associated with pulmonary emphysema in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K053072
Methodology: https://510kreport.com/methodology