# K072965: Dimension Vista C1 in; Flex Reagent Cartridge, Cal, Con

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 21, 2007 after 60 days
- Product code: DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5250
- 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 K962410 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960257: N Antiserum to C1 Inhibitor, Behring Diagnostics, Inc. (1996) Summary page 1.
- K962410: N Protein Standard PY, Behring Diagnostics, Inc. (1996) Summary page 1.
- K962407: N/T Protein Control PY, Behring Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
The CGIN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer). The C1 INCAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (Cl IN) method on the Dimension Vista® System. C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of C1 Inhibitor (Cl IN).

Source page: https://510kreport.com/device/K072965
Methodology: https://510kreport.com/methodology