# K190298: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 - Pathway: 510(k) (Traditional) - Applicant: Beckman Coulter Biomedical GmbH - Decided: Oct 4, 2019 after 235 days - Product code: CDD (Radioassay, Vitamin B12) - Device class: 2 - Regulation: 21 CFR 862.1810 - 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: 5 generations back to K925637 (1993). 16 ancestors in all. No later device cites it as a predicate yet. 0 of 17 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K110413: Power Processor Sample Processing System with Generic Connections, Beckman Coulter, Inc. (2011) Summary page 7. - K023764: Unicel Dxi 800 Access Immunoassay System, Model 973100, Beckman Coulter, Inc. (2003) Summary page 9. - K926221: Access Ferritin Assay, Bio-Rad Laboratories, Inc. (1993) Summary page 9. - K060774: Folate on the Access Immunoassay Systems, Model A14208, Beckman Coulter, Inc. (2006) Summary page 9. - K042281: Modification to Access Hypersensitive HTSH Assay, Beckman Coulter, Inc. (2004) Summary page 9. - K955436: Access Vitamin B12 Assay (Modification), Bio-Rad Laboratories, Inc. (1996) Summary page 9. ## Recalls of this device - Jun 2, 2023 · Class II · Z-2144-2023: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results - Jun 2, 2023 · Class II · Z-2145-2023: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results - Jul 21, 2021 · Class II · Z-2602-2021: There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Sam - Jun 17, 2020 · Class II · Z-2983-2020: The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system ## Indications for use The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system. The DxI 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxI 800 System is an in vitro diagnostic device for use in the clinical laboratory. The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and plasma (heparin) or red blood cells using the Access Immunoassay Systems. Folate levels in serum and plasma (heparin) or red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia. The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. This assay is capable of providing 3rd generation TSH results. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. Source page: https://510kreport.com/device/K190298 Methodology: https://510kreport.com/methodology