510(k) · Cleared
Recalled · Class II · 2017Synchron LX20 Clinical Systems, Creatinine Test Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Jun 1, 2007 as substantially equivalent to K965240 (Beckman Instruments, Inc., 1997) after a 25-day review. Its family tree reaches back 2 generations to 1988. It has been recalled once.
- Decided
- Jun 1, 2007
- Review
- 25 days
- Class
- Class II
- Product code
- CGX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883181 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK883181 Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. · 1988 · Recalled
- 1 generation backK965240 Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin…Beckman Instruments, Inc. · 1997 · Recalled
- This deviceK071277 Synchron LX20 Clinical Systems, Creatinine Test SystemsBeckman Coulter, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883181 | Synchron CX4/CX5 Clinical Chemistry Analyzer Reage | Beckman Instruments, Inc. | 1988 | 2 |
| −1 | K965240 | Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent… | Beckman Instruments, Inc. | 1997 | 12 |
| 0 (this device) | K071277 | Synchron LX20 Clinical Systems, Creatinine Test Systems | Beckman Coulter, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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 CGX? 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 CGX device
- #1 K242685 Atellica® CH Creatinine_3 (Crea3)score 12.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K965240 | Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX…Summary page 1…Clinical Systems, claims substantial equivalence to the Beckman Coulter SYNCHRON LX20 Clinical System currently in commercial distribution, FDA 510(k) Number K965240. 5.0 Device Description The SYNCHRON LX20 System determines creatinine concentration by means of the Jaffe ra… | 1997 |
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 |
|---|---|---|---|---|
| May 15, 2017 | Class II | Z-2730-2017 | Nonconforming Material/Component | The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K965240.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGX
25in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGX
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGX
34in 2025
MAUDE reports naming product code CGX, 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 | 4 | 25 | 0 | 15 |
| 2008 | 0 | — | 1 | 27 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 1 | — | 2 | 13 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 2 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Beckman Coulter AQUA CAL 1, 2, and 3 are intended for use on SYNCHRON LX® and UniCel® DxC Systems for the calibration of Sodium, Potassium, Chloride, Urea Nitrogen, Urea, Glucose Creatinine, Calcium, Carbon Dioxide, and Phosphorus.
CREm reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System and SYNCHRON® Systems AQUA CAL I and 2, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071277 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071277: Synchron LX20 Clinical Systems, Creatinine Test Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071277
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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