# K081161: Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista Syst

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 28, 2008 after 95 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: 7 generations back to K002852 (2000). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951635: Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator, Control, Beckman Instruments, Inc. (1995) Summary page 1.
- K042735: N Antisera to Human Immunoglobulins (Igg, Iga and Igm), Dade Behring, Inc. (2005) Summary page 1.
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dade Behring, Inc. (2008) Summary page 1.

## Indications for use
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 a - Microglobulin (AlMIC), specialty Albumin (sALB)*, Immunoglobulin G (IGG -C)*, Immunoglobulin G (IGG-U)** and Microalbumin (MALB). * For Cerebrospinal fluid (CSF) ** For urine PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a4-Acid Glycoprotein (A1AG) Immunoglobulin G (IGG) [serum/plasmal, Immunoglobulin G (IGG-C) [cerebrospinal fluid] and Immunoglobulin G (1IGG-U) [urine] as-Antitrypsin (A1AT) Immunoglobulin G Subclass 1 (1IGG1) B2-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) The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma, cerebrospinal fluid (CSF) and urine 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.

Source page: https://510kreport.com/device/K081161
Methodology: https://510kreport.com/methodology