# K090588: Power Processor Sample Processing System with Generic Connection Module, Model: 4210 - Pathway: 510(k) (Traditional) - Applicant: Beckman Coulter, Inc. - Decided: May 27, 2009 after 84 days - Product code: CDD (Radioassay, Vitamin B12) - Device class: 2 - Regulation: 21 CFR 862.1810 - 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 K925637 (1993). 14 ancestors in all. 4 later devices descend from it; 1 cites it directly. 0 of 19 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K043546: Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module, Dade Behring, Inc. (2005) Summary page 1. - K023764: Unicel Dxi 800 Access Immunoassay System, Model 973100, Beckman Coulter, Inc. (2003) Summary page 1. - K926221: Access Ferritin Assay, Bio-Rad Laboratories, Inc. (1993) Summary page 1. - K060774: Folate on the Access Immunoassay Systems, Model A14208, Beckman Coulter, Inc. (2006) Summary page 1. - K042281: Modification to Access Hypersensitive HTSH Assay, Beckman Coulter, Inc. (2004) Summary page 1. - K955436: Access Vitamin B12 Assay (Modification), Bio-Rad Laboratories, Inc. (1996) Summary page 1. ## Most influential descendants - K110413: Power Processor Sample Processing System with Generic Connections (2011), 3 descendants of its own - K140496: Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents (2014), 1 descendant of its own - K190298: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 (2019), 0 descendants of its own - K192064: LIAISON Vitamin B12 (2019), 0 descendants of its own ## Indications for use The basic Power Processor is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting step to presentation of centrifuged and decapped samples into Generic or Personality Racks for specific instruments. The Power Processor can be configured with optional software and hardware to allow processing of sample tubes on Generic Connection Instruments. The Power Processor performs all pre-analytical sample tube preparation, and then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks. The UniCel Dxl 800 Access Immunoassay System with laboratory automation connection 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 Dxl 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for determination of various analytes, such as Vitamin 612, Ferritin, Folate and hTSH along with other various enzyme immunoassays assays that may be adaptable to the analyzer depending on the reagent used to induce the enzyme immunoassay reaction. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory. The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay 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, plasma (heparin) and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia. The Access HYPERsensitive hTSH assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum using the Access Immunoassay Systems. 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 assay for the quantitative determination of vitamin B12 in human serum and plasma (heparin) using 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/K090588 Methodology: https://510kreport.com/methodology