# K063663: Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 21, 2007 after 103 days
- Product code: DDG (Transferrin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5880
- 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.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053072: N Antisera to Human ALPHA1-Antitrypsin, Dade Behring, Inc. (2006) 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.

## Most influential descendants
- K072435: Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H (2007), 4 descendants of its own
- K071980: Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,H (2007), 2 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 STFR method is an in vitro diagnostic test for the quantitative determination of soluble transferrin receptor in human serum and heparinized plasma on the Dimension Vista® System. Measurements of soluble transferrin receptor aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M ([GM), Prealbumin (PREALB) and Soluble Transferrin Receptor (STFR) methods on the Dimension Vista® System. PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and Soluble Transferrin Receptor (STFR) on the Dimension Vista® System.

Source page: https://510kreport.com/device/K063663
Methodology: https://510kreport.com/methodology