# K063508: Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 23, 2007 after 64 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002852 (2000). 16 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062055: Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High, Dade Behring, Inc. (2006) Summary page 1.
- K062035: Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control, Dade Behring, Inc. (2006) Summary page 1.
- K061990: Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control, Dade Behring, Inc. (2006) 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
- 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
- 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
Dimension Vista Protein 1 Calibrator Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the α1-acid glycoprotein (AIAG), C3 complement (03), C4 complement (C4), haptoglobin (HAPT), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) methods on the Dimension Vista® System. Dimension Vista Protein 1 Control L, M and H Protein 1 Control L, M and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-acid glycoprotein (AIAG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System. Dimension Vista Protein 2 Calibrator Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP), and rheumatoid factors (RF) methods on the Dimension Vista® System. Dimension Vista Protein 2 Control L and H Protein 1 Control L and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of antistreptolysin O (ASL), C-reactive protein (CRP), and rheumatoid factors (RF) on the Dimension Vista® System. Dimension Vista Protein 3 Calibrator Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the α1-microglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System. Dimension Vista Protein 3 Control Protein 3 Control is for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-microglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.

Source page: https://510kreport.com/device/K063508
Methodology: https://510kreport.com/methodology