# K071980: Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,H

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 11, 2007 after 55 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002852 (2000). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator (2008), 1 descendant 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
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a,-Acid Glycoprotein (A1AG); a,-Antitrypsin (A1AT); B.-Microglobulin (B2MIC); C3 Complement (C3); C4 Complement (C4); Ceruloplasmin (CER); Haptoglobin (HAPT); Hemopexin (HPX); Homocysteine (HCYS); Immunoglobulin A (IGA); Immunoglobulin E (IGE); Immunoglobulin G (IGG); Immunoglobulin G Subclass 1 (IGG1); Immunoglobulin G Subclass 2 (IGG2); Immunoglobulin G Subclass 3 (IGG3); Immunoglobulin G Subclass 4 (IGG4); Immunoglobulin M (IGM); Prealbumin (PREALB); Retinol Binding Protein (RBP); soluble Transferrin Receptor (STFR); Transferrin (TRF) 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 (AlAG); o1 -Antitrypsin (AlAT); C3 Complement (C3); C4 Complement (C4); Ceruloplasmin (CER); Haptoglobin (HAPT); Hemopexin (HPX); Homocysteine (HCYS); Immunoglobulin A (IGA); Immunoglobulin E (IGE); Immunoglobulin G (IGG); Immunoglobulin G Subclass 1 (IGG1); Immunoglobulin G Subclass 2 (IGG2); Immunoglobulin G Subclass 3 (IGG3); Immunoglobulin G Subclass 4 (IGG4); Immunoglobulin M (1GM); Prealbumin (PREALB); Retinol Binding Protein (RBP); soluble Transferrin Receptor (STFR); Transferrin (TRF) 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); ao-Antitrypsin (A1AT); P 2-Microglobulin (B2MIC); C3 Complement (C3); C4 Complement (C4); Ceruloplasmin (CER); Haptoglobin (HAPT); Hemopexin (HPX); Homocysteine (HCYS); Immunoglobulin A (IGA); Immunoglobulin E (IGE); Immunoglobulin G (IGG); Immunoglobulin G Subclass 1 (IGG1); Immunoglobulin G Subclass 2 (IGG2); Immunoglobulin G Subclass 3 (IGG3); Immunoglobulin G Subclass 4 (IGG4); Immunoglobulin M (IGM); Prealbumin (PREALB); Retinol Binding Protein (RBP); soluble Transferrin Receptor (STFR); Transferrin (TRF) 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: ao-Acid Glycoprotein (A1AG); a1 -Antitrypsin (A1AT); 132-Microglobulin (B2MIC); C3 Complement (C3); C4 Complement (C4); Ceruloplasmin (CER); Haptoglobin (HAPT); Hemopexin (HPX); Homocysteine (HCYS); Immunoglobulin A (IGA); Immunoglobulin E (IGE); Immunoglobulin G (IGG); Immunoglobulin G Subclass 1 (IGG1); Immunoglobulin G Subclass 2 (IGG2); Immunoglobulin G Subclass 3 (IGG3); Immunoglobulin G Subclass 4 (IGG4); Immunoglobulin M (IGM); Prealbumin (PREALB); Retinol Binding Protein (RBP); soluble Transferrin Receptor (STFR); Transferrin (TRF)

Source page: https://510kreport.com/device/K071980
Methodology: https://510kreport.com/methodology