# K061338: Dimension Vista Iga Flex Reagent Cartridge Assay

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 6, 2006 after 52 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- 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.
7 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042735: N Antisera to Human Immunoglobulins (Igg, Iga and Igm), Dade Behring, Inc. (2005) Summary page 2.
- K012470: Modification to N Protein Standard SL, Dade Behring, Inc. (2001) Summary page 2.
- K012468: Modification to N/T Protein Control SL, Dade Behring, Inc. (2001) Summary page 1.

## Most influential descendants
- K062055: Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High (2006), 6 descendants of its own
- K063508: Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an (2007), 5 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
- 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
The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma on the Dimension VistaTM System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. PROTI CAL is an in vitro diagnostic product for the calibration of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) methods on the Dimension VistaTM System. For use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K061338
Methodology: https://510kreport.com/methodology