# K972640: Tina-Quant Alpha Particle-1-Antitrypsin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 9, 1998 after 178 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Behring BN® α-1-Antitrypsin assay: named in the summary without a submission number

## Most influential descendants
- K982382: Cobas Integra Reagent Cassettes (1998), 0 descendants of its own

## Indications for use
Immunological in vitro immunoturbidometric test for the quantitative determination of α-1-antitrypsin in human serum and plasma. 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.

Source page: https://510kreport.com/device/K972640
Methodology: https://510kreport.com/methodology