# K081299: Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Aug 8, 2008 after 92 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: 3 generations back to K955858 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053075: N Antisera to Human Transferrin, Dade Behring, Inc. (2006) Summary page 1.
- K012470: Modification to N Protein Standard SL, Dade Behring, Inc. (2001) Summary page 1.
- K032237: N/T Protein Control, Dade Behring, Inc. (2003) Summary page 1.

## Indications for use
The TRF method is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. PROT3 CON is an assayed intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of a 1-Microglobulin (A1 MIC), specialty Albumin (sALB*), Immunoglobulin G (IGG -C*), Microalbumin (MALB) and Transferrin (TRF-U**). *For Cerebrospinal fluid (CSF) **For urine PRQOT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a -Acid Glycoprotein (AMAG) and Immunoglobulin G (IGG) [serum/plasma] and (IGG-C) [cerebrospinal fluid] a -Antitrypsin (A1AT) Immunoglobulin G Subclass 1 (IGG1) Bz-Microglobulin (B2MIC) Immunoglobulin G Subclass 2 (IGG2) C3 Complement (C3) Immunoglobulin G Subclass 3 (IGG3) C4 Complement (C4) Immunoglobulin G Subclass 4 (IGG4) Ceruloplasmin (CER) Immunoglobulin M (IGM) Haptoglobin (HAPT) Prealbumin (PREALB) Hemopexin (HPX) Retinol Binding Protein (RBP) Homocysteine (HCYS) soluble Transferrin Receptor (STFR) Immunoglobulin A (IGA) Transferrin (TRF) [serum/plasma] and Immunoglobulin E (IGE) (TRF-U) [urine]

Source page: https://510kreport.com/device/K081299
Methodology: https://510kreport.com/methodology