510(k) · Cleared
Recalled · Class II · 2014Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System Software Version 5.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Apr 27, 2011 as substantially equivalent to K042291 (Beckman Coulter, Inc., 2004) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 1988. It has been recalled 3 times.
- Decided
- Apr 27, 2011
- Review
- 118 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K883181 (1988). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK883181 Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. · 1988 · Recalled
- 2 generations backK965240 Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin…Beckman Instruments, Inc. · 1997 · Recalled
- 1 generation backK042291 Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc. · 2004 · Recalled
- This deviceK103842 Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC…Beckman Coulter, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883181 | Synchron CX4/CX5 Clinical Chemistry Analyzer Reage | Beckman Instruments, Inc. | 1988 | 2 |
| −2 | K965240 | Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent… | Beckman Instruments, Inc. | 1997 | 12 |
| −1 | K042291 | Unicel DXC 600 and 800 Synchron Systems | Beckman Coulter, Inc. | 2004 | 34 |
| 0 (this device) | K103842 | Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800… | Beckman Coulter, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K042291 | Unicel DXC 600 and 800 Synchron SystemsSummary page 1…Candidate(s) Predicate ] Manufacturer Docume~nt UniCel® DxC 800 UniCel® DxC 600/800 Beckman Coulter, K042291, SYNCHRON® System SYNCHRQN® System Inc. K060256 Software Version 5.… | 2004 |
| * | K060256 | Unicel DXC 600I Synchron Access Clinical SystemSummary page 1…niCel® DxC 800 UniCel® DxC 600/800 Beckman Coulter, K042291, SYNCHRON® System SYNCHRQN® System Inc. K060256 Software Version 5.0 Software Version(s) 1.0 and 1.4 The Uni… | 2006 |
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 |
|---|---|---|---|---|
| Apr 22, 2014 | Class II | Z-2272-2016 | Nonconforming Material/Component | Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems. |
| Sep 3, 2012 | Class II | Z-0123-2013 | Software change control | Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned… |
| Jul 6, 2012 | Class II | Z-0059-2013 | Nonconforming Material/Component | The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Aliquotter (UCTA) serial numbers between 547 and 574 may cause… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 7 of the 8 ancestors have a recall of any class.
- 5 other devices also cite its predicate K042291.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The UniCel DxC 800 System Software Version 5.0 is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of cleared clinical laboratory assays, such as glucose.
GLUCm reagent is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, idiopathic hypoglycemnia, and pancreatic islet cell carcinoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103842: Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System Software Version 5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103842
Report an extraction error
Are you the manufacturer?
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