# K061990: Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 19, 2006 after 68 days
- Product code: DCF (Albumin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- 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 K955858 (1996). 5 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 1.
- K012470: Modification to N Protein Standard SL, Dade Behring, Inc. (2001) Summary page 1.
- K991704: N/T Protein Control LC, Dade Behring, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K233663: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (2023), 0 descendants of its own

## Indications for use
The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista Tm System. Measurement of albumin aids in the diagnosis of kidney and intestinal disease. Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista TM System. Protein 3 Control is an assayed intralaboratory quality contro! for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K061990
Methodology: https://510kreport.com/methodology