# K061852: Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low, Medium, High

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 22, 2006 after 84 days
- Product code: CZW (Complement C3, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- 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)
- K050665: N Antisera to Human Complement Factors (C3C, C4), Dade Behring, Inc. (2005) Summary page 2.
- 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 C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension VistaTM System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein. The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension VistaTM System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein. Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), and Immunoglobulin M (]GM) on the Dimension VistaTM System. Protein 1 Control L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K061852
Methodology: https://510kreport.com/methodology