510(k) · Cleared
ClearedUrine/CSF Albumin, Urine/CSF Albumin Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter Ireland, Inc. · DCF Albumin, Antigen, Antiserum, Control
Cleared on Oct 15, 2014 as substantially equivalent to K082251 (Beckman Coulter, Inc., 2009) and 2 other predicates after a 54-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Oct 15, 2014
- Review
- 54 days
- Class
- Class II
- Product code
- DCF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K964695 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964695 Immage Immunochemistry System Albumin (Alb) ReagentBeckman Instruments, Inc. · 1997
- This deviceK142346 Urine/CSF Albumin, Urine/CSF Albumin CalibratorBeckman Coulter Ireland, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964695 | Immage Immunochemistry System Albumin (Alb) Reagent | Beckman Instruments, Inc. | 1997 | — |
| 0 (this device) | K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | Beckman Coulter Ireland, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2009 | 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 DCF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K082251 | Synchron Systems Microalbumin (MA) Reagent, Model 475100Summary page 4…/CSF Albumin, SYNCHRON® Systems Model Nos. Microalbumin (MA) Reagent, Beckman Coulter, Inc. K082251 B38858 Model No. 475100 B46435 CSF Predicate Proposed Dev… | 2009 |
| * | K964695 | Immage Immunochemistry System Albumin (Alb) ReagentSummary page 4…IMMAGE® Immunochemistry Beckman Coulter, Inc. Model Nos. System Albumin (ALB) Reagent, (Previously Beckman K964695 B38858 Model No. 447600 Instruments, Inc.) B46435 Ca… | 1997 |
| * | K000331 | Synchron LX Systems Microalbumin CalibratorSummary page 4…ne/CSF Albumin SYNCHRON® Systems Calibrator, Microalbumin (MA) Calibrator, Beckman Coulter, Inc. K000331 Model No. Model No. 475089 B38859 Urine/CSF Albumin and Urine/CSF Alb… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All DCF devicesDCF Albumin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DCF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DCF
167in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DCF
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCF
12in 2025
MAUDE reports naming product code DCF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 167 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Urine/CSF Albumin:
The Urine/CSF Albumin reagent is intended to be used for the quantitation of albumin concentration in human urine and cerebrospinal fluid (CSF) on the Beckman Coulter AU clinical chemistry systems as an aid in the diagnosis of kidney diseases. For in vitro diagnostic use only.
Urine/CSF Albumin Calibrator:
The Urine/CSF Albumin calibrator is intended to be used to calibrate the Urine/CSF Albumin reagent on the Beckman Coulter AU clinical chemistry systems. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142346: Urine/CSF Albumin, Urine/CSF Albumin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142346
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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