# K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 26, 2008 after 69 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: 6 generations back to K002852 (2000). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 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 3.
- K051087: Dimension Vista Integrated System, Dade Behring, Inc. (2005) Summary page 3.
- K071980: Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,H, Dade Behring, Inc. (2007) Summary page 1.
- K072435: Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H, Dade Behring, Inc. (2007) Summary page 1.

## Most influential descendants
- K081161: Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista Syst (2008), 0 descendants of its own

## Indications for use
The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: α1-Acid Glycoprotein (AlAG) Immunoglobulin G (IGG) [serum/plasma] and Immunoglobulin G (IGG-C) [cerebrospinal fluid] α1-Antitrypsin (AlAT) Immunoglobulin G Subclass 1 (IGG1) β2-Microglobulin (B2MIC) Immunoglobulin G Subclass 2 (IGG2) C3 Complement (C3) Immunoglobulin G Subclass 3 (IGG3) C4 Complement (C4) Immunoglobulin G Subclass 4 (IGG4) Ceruloplasmin (CER) Immunoglobulin M (IGM) Haptoglobin (HAPT) Prealbumin (PREALB) Hemopexin (HPX) Retinol Binding Protein (RBP) Homocysteine (HCYS) soluble Transferrin Receptor (STFR) Immunoglobulin A (IGA) Transferrin (TRF) Immunoglobulin E (IGE) PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of α1-Microglobulin (A1MIC), specialty Albumin (sALB)*, Immunoglobulin G (IGG-C)* and Microalbumin (MALB). *For Cerebrospinal fluid (CSF)

Source page: https://510kreport.com/device/K073561
Methodology: https://510kreport.com/methodology