510(k) · Cleared
Recalled · Class II · 2023DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter Biomedical GmbH · CDD Radioassay, Vitamin B12
Cleared on Oct 4, 2019 as substantially equivalent to K110413 (Beckman Coulter, Inc., 2011) and 5 other predicates after a 235-day review. Its family tree reaches back 5 generations to 1993. It has been recalled 4 times.
- Decided
- Oct 4, 2019
- Review
- 235 days
- Class
- Class II
- Product code
- CDD
- Recalls
- 4
- Predicates
- 6
Its longest line of descent runs back 5 generations to K925637 (1993). 16 ancestors in all, the oldest K922823 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK925637 Access HTSH AssayBio-Rad Laboratories, Inc. · 1993
- 4 generations backK023093 Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2002
- 3 generations backK042281 Modification to Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2004
- 2 generations backK090588 Power Processor Sample Processing System with Generic Connection…Beckman Coulter, Inc. · 2009
- 1 generation backK110413 Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · Recalled
- This deviceK190298 DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access…Beckman Coulter Biomedical GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925637 | Access HTSH Assay | Bio-Rad Laboratories, Inc. | 1993 | — |
| −4 | K023093 | Access Hypersensitive HTSH Assay | Beckman Coulter, Inc. | 2002 | — |
| −3 | K042281 | Modification to Access Hypersensitive HTSH Assay | Beckman Coulter, Inc. | 2004 | — |
| −2 | K090588 | Power Processor Sample Processing System with Generic Connection Module… | Beckman Coulter, Inc. | 2009 | — |
| −1 | K110413 | Power Processor Sample Processing System with Generic Connections | Beckman Coulter, Inc. | 2011 | 2 |
| 0 (this device) | K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate… | Beckman Coulter Biomedical GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CDD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CDD device
- #1 K233541 ARCHITECT Active-B12 (Holotranscobalamin)score 8.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110413 | Power Processor Sample Processing System with Generic ConnectionsSummary page 7…idate(s) Predicate Manufacturer Document Number DxA 5000 Power Processor Sample Beckman Coulter, K110413 Processing System Inc. 5.0 Device Description The DxA system is a high t… | 2011 |
| * | K023764 | Unicel Dxi 800 Access Immunoassay System, Model 973100Summary page 9…Predicate Device Name and 510k information: Power Processor Sample Processing System (k110413) Beckman Coulter UniCel® DxI 800 Access® Immunoassay System (k023764) Beckman Coulter Access® Ferritin assay (k926221) Beckman Coulter Access® Folate assay (k060774) Beckman Cou… | 2003 |
| * | K926221 | Access Ferritin AssaySummary page 9…r Processor Sample Processing System (k110413) Beckman Coulter UniCel® DxI 800 Access® Immunoassay System (k023764) Beckman Coulter Access® Ferritin assay (k926221) Beckman Coulter Access® Folate assay (k060774) Beckman Coulter Access® HYPER sensitive hTSH assay (k042281)… | 1993 |
| * | K060774 | Folate on the Access Immunoassay Systems, Model A14208Summary page 9…Beckman Coulter UniCel® DxI 800 Access® Immunoassay System (k023764) Beckman Coulter Access® Ferritin assay (k926221) Beckman Coulter Access® Folate assay (k060774) Beckman Coulter Access® HYPER sensitive hTSH assay (k042281) Beckman Coulter Access® Vitamin B12 assay (k955436)… | 2006 |
| * | K042281 | Modification to Access Hypersensitive HTSH AssaySummary page 9…Beckman Coulter Access® Ferritin assay (k926221) Beckman Coulter Access® Folate assay (k060774) Beckman Coulter Access® HYPER sensitive hTSH assay (k042281) Beckman Coulter Access® Vitamin B12 assay (k955436) The DxA 5000 has the following similarities to the previousl… | 2004 |
| * | K955436 | Access Vitamin B12 Assay (Modification)Summary page 9…Beckman Coulter Access® Folate assay (k060774) Beckman Coulter Access® HYPER sensitive hTSH assay (k042281) Beckman Coulter Access® Vitamin B12 assay (k955436) The DxA 5000 has the following similarities to the previously cleared Power Processor Sample Processing System (… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 2, 2023 | Class II | Z-2144-2023 | Software design | 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 | Software design | 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 | Under Investigation by firm | 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. Samples are dropped when they reach the… |
| Jun 17, 2020 | Class II | Z-2983-2020 | Device Design | 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 . |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 7 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K110413.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · CDD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CDD
147in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CDD
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDD
44in 2025
MAUDE reports naming product code CDD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 36 |
| 2012 | 3 | 147 | 0 | 23 |
| 2013 | 1 | — | 0 | 45 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 9 |
| 2018 | 0 | — | 2 | 15 |
| 2019 | 2 | — | 1 | 14 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 28 |
| 2022 | 1 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (383 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190298: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190298
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026