# K061845: Dimension Vista Igm Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 24, 2006 after 56 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.
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)
- K042735: N Antisera to Human Immunoglobulins (Igg, Iga and Igm), Dade Behring, Inc. (2005) 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
Dimension VistaTM IGM Flex® reagent cartridge: The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma on the Dimension VistaTM System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. Dimension VistaTM Protein I Calibrator Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension VistaTM System. Dimension VistaTM Protein I Control L, M and H Protein 1 Control L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) on the Dimension Vista m System.

Source page: https://510kreport.com/device/K061845
Methodology: https://510kreport.com/methodology