# K083463: Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1 Control M

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Mar 13, 2009 after 109 days
- Product code: JZG (System, Test, Beta-2-Microglobulin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5630
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992858 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002731: N Latex B2-Microglobulin, Dade Behring, Inc. (2000) Summary page 1.
- K052788: N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H, Dade Behring, Inc. (2006) Summary page 2.

## Recalls of this device
- May 23, 2017 · Class II · Z-0174-2018: Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin
- May 23, 2017 · Class II · Z-0175-2018: Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin
- Nov 3, 2015 · Class II · Z-1030-2016: Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Fle
- Jul 23, 2015 · Class II · Z-2450-2015: customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for fals

## Indications for use
The B2MIC method is an in vitro diagnostic test for the quantitative measurement of β2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista® System. Measurements of beta-2-microglobulin, aid in the diagnosis of active rheumatoid arthritis and kidney disease. PROT1 CON L is an assayed, low-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) a2-Macroglobulin (A2MAC) β2-Microglobulin (B2MIC, B2MU**) 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) specialty Albumin (sALB*) Transferrin (TRF) * For serum and plasma ** For urine PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) a2-Macroglobulin (A2MAC) β2-Microglobulin (B2MIC, B2MU**) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG, IGG-C*, IGG-U**) 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) *For cerebrospinal fluid (CSF) **For Urine PROT1 CON M is an assayed, mid-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) a2-Macroglobulin (A2MAC) β2-Microglobulin (B2MIC, B2MU**) 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) specialty Albumin (sALB*) Transferrin (TRF) * For serum and plasma ** For urine

Source page: https://510kreport.com/device/K083463
Methodology: https://510kreport.com/methodology