# K082503: Dimension Vista LG Light Chains, Type Kappa, Dimension Vista LG Light Chains, Type Lambda, Dimension Vista Protein 1 Cal - Pathway: 510(k) (Traditional) - Applicant: Siemens Healthcare Diagnostics - Decided: Dec 19, 2008 after 112 days - Product code: DFH (Kappa, Antigen, Antiserum, Control) - Device class: 2 - Regulation: 21 CFR 866.5550 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K002852 (2000). 5 ancestors in all. No later device cites it as a predicate yet. 0 of 6 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 2. - K012470: Modification to N Protein Standard SL, Dade Behring, Inc. (2001) Summary page 2. - K012468: Modification to N/T Protein Control SL, Dade Behring, Inc. (2001) Summary page 2. ## Recalls of this device - May 23, 2017 · Class II · Z-0173-2018: 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 ## Indications for use Dimension Vista® KAPPA Flex® reagent cartridge: The KAPPA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, kappa type in human serum and plasma on the Dimension Vista® System. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. Dimension Vista® PROT 1 CAL: PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for; as-Acid Glycoprotein (A1AG) Immunoglobulin A (IGA) as-Antitrypsin (A1AT) Immunoglobulin E (IGE) dp- Macroglobulin (AZMAC) Immunoglobulin G (IGG, IGG-C*, IGG-U*) B2-Microglobulin (B2MIC) Immunoglobulin G Subclass 1 (IGG1) C3 Complement (C3) fmmunoglobulin G Subclass 2 (IGG2) C4 Complement (C4) Immunoglobulin G Subclass 3 (IGG3) Ceruloplasmin (CER) Immunoglobulin G Subclass 4 (IGG4) Haptoglobin (HAPT) Immunoglobulin M (IGM) Hemopexin (HPX) Prealbumin (PREALB) Homocysteine (HCYS) Retinol binding Protein (RBP) lg fight chains, type Kappa (KAPPA) soluble Transferrin Receptor (STFR) Ig light chains, type Lambda (LAMBDA) Transferrin (TRF) *For cerebrospinal fluid (CSF) ** For urine PROTi CON M is an assayed, mid-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vistao System in the quantitative determination of: a,-Acid Glycoprotein (AlAG) Immunoglobulin E (IGE) a1-Antitrypsin (AIAT) Immunoglobulin G (IGG, IGG-C*) a2-Macroglobulin (A2MAC) Immunoqlobulin G Subclass I (IGG1) P2-Microglobulin (1B2MIC) Imuolbulin G Subclass 2 (IGG2) 03 Complement (03) Imuolbulin G Subclass 3 (IGG3) 04 Complement (C4) Immunoglobulin G Subclass 4 (IGG4) Ceruloplasmin (CER) Immunoglobulin M ([GM) Haptoglobin (HAPT) Prealbumin (PREALB) Hemopexin (HPX) Retinol binding Protein (RBP) Homocysteine (HCYS) soluble Transferrin Receptor (STFR) Ig light chains, type Kappa (KAPPA) specialty Albumin (sALB) Ig light chains, type Lambda (LAMBDA) Transferrin (TRF) Immunoglobulin A (IGA) * For serum and plasma Dimension Vista ® LAMBDA Flex® reagent cartridge: The LAMBDA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, lambda type in human serum and plasma on the Dimension Vista® System. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. 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: a,-Acid Glycoprotein (A1AG) Immunoglobulin E (IGE) a1 -Antitrypsin (A1AT) Immunoglobulin G (IGG, IGG-C*) a 2-Macroglobulin (A2MAC) Immunoglobulin G Subclass 1 (IGG1) C3 Complement (C3) Immunoglobulin G Subclass 2 (IGG2) C4 Complement (C4) Immunoglobulin G Subclass 3 (IGG3) Ceruloplasmin (CER) Immunoglobulin G Subclass 4 (IGG4) Haptoglobin (HAPT) Immunoglobulin M(IGM) Hemopexin (HPX) Prealbumin (PREALB) Homocysteine (HCYS) Retinol binding Protein (RBP) Ig light chains, type Kappa (KAPPA) soluble Transferrin Receptor (STFR) Ig light chains, type Lambda (LAMBDA) Specialty Albumin (sALB) Immunoglobulin A (IGA) Transferrin (TRF) For serum and plasma PROT1 CON H is an assayed, high -level, intralaboratory quality control for the assessment of precision .and analytical bias on the Dimension Vista® System in the quantitative determination of: a,-Acid Glycoprotein (AAG) Immunoglobulin E (IGE) al-Antitrypsin (AlAT) Immunoglobulin G (IGG, IGG-C*) a 2-Macroglobulin (A2MAC) Immunoglobulin G Subclass 1 (IGG1) 32-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) Ig light chains, type Kappa (KAPPA) specialty Albumin (sALB) Ig light chains, type Lambda (LAMBDA) Transferrin (TRF) Immunoglobulin A (IGA) * For serum and plasma Source page: https://510kreport.com/device/K082503 Methodology: https://510kreport.com/methodology