# K072435: Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 17, 2007 after 48 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: 5 generations back to K002852 (2000). 19 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063508: Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an, Dade Behring, Inc. (2007) Summary page 1.
- K063663: Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H, Dade Behring, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the ao-Microglobulin (A1MIC), Cystatin C (CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods. * For serum, plasma and cerebrospinal fluid PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a,-Micro.globulin (AlMIC), specialty Albumin (sALB) 1 and Microalbumin (MALB) on the Dimension Vista System. 1For cerebrospinal fluid (CSF) PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a,-Acid Glycoprotein (AIAG) Immunoglobulin E (IGE) a1 -Antitrypsin (A1AT) Immunoglobulin G (IGG) C3 Complement (C3) Immunoglobulin M(IGM) C4 Complement (C4) Prealbumin (PREALB) Ceruloplasmin (CER) specialty Albumin* (sALB) Haptoglobin (HAPT) soluble Transferrin Receptor (STFR) Homocysteine (HCYS) Transferrin (TRF) Immunoglobulin A (IGA) *For serum and plasma PROT1 CON M is an assayed, mid-level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a,-Acid Glycoprotein (A1AG) Immunoglobulin A (IGA) a 1-Antitrypsin (AIAT) Immunoglobulin E (IGE) 132- Microglobulin (B2MIC) Immunoglobulin G (IGG) C3 Complement (C3) Immunoglobulin M (IGM) C4 Complement (C4) Prealbumin (PREALB) Ceruloplasmin (CER) specialty Albumin* (sALB) Haptoglobin (HAPT) soluble Transferrin Receptor (STFR) Homocysteine (HCYS) Transferrin (TRF) *For serum and plasma PROT1 CON H is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of: a,-Acid Glycoprotein (A1AG) Immunoglobulin A (IGA) o1 -Antitrypsin (A1AT) Immunoglobulin E (IGE) P2- Microglobulin (B2MIC) Immunoglobulin G (IGG) C3 Complement (C3) Immunoglobulin M (IGM) C4 Complement (C4) Prealbumin (PREALB) Ceruloplasmin (CER) specialty Albumin* (sALB) Haptoglobin (HAPT) soluble Transferrin Receptor (STFR) Homocysteine (HCYS) Transferrin (TRF) *For serum and plasma

Source page: https://510kreport.com/device/K072435
Methodology: https://510kreport.com/methodology