# K063610: Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium and High

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 11, 2007 after 38 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: 2 generations back to K002852 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053072: N Antisera to Human ALPHA1-Antitrypsin, Dade Behring, Inc. (2006) Summary page 1.
- K012470: Modification to N Protein Standard SL, Dade Behring, Inc. (2001) Summary page 1.
- K012468: Modification to N/T Protein Control SL, Dade Behring, Inc. (2001) Summary page 1.

## Indications for use
The A1AT method is an in vitro diagnostic test for the quantitative determination of a 1-antitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of ai-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema. PROT1 CAL is an in vitro diagnostic product for the calibration of the al-antitrypsin (AIAT), C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System. PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of al-antitrypsin (AlAT), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG2 , immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista System.

Source page: https://510kreport.com/device/K063610
Methodology: https://510kreport.com/methodology