510(k) · Cleared
ClearedDimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114, DC114
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DCF Albumin, Antigen, Antiserum, Control
Cleared on Jan 12, 2004 as substantially equivalent to K972929 (Behring Diagnostics, Inc., 1997) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jan 12, 2004
- Review
- 66 days
- Class
- Class II
- Product code
- DCF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K895883 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895883 | Beckman MA Microalbumin Reagent Kit | Beckman Instruments, Inc. | 1989 | — |
| −1 | K972929 | N Antiserum to Human Albumin | Behring Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K033525 | Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator… | Dade Behring, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (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 |
|---|---|---|---|
| * | K972929 | N Antiserum to Human AlbuminSummary page 1…albumin assay systems such as the Dade Behring nephelometric (BN II) N Antiserum to Human Albumin assay (K972929). Calibrator: Other commercially available calibrators such as the Dade… | 1997 |
| * | K936201 | Urinary Albumin CalibratorSummary page 1…Calibrator: Other commercially available calibrators such as the Dade Behring Urinary Albumin Calibrator (K936201). Device Description(s): Method The Microalbumin (MALB) method (DF1 14) is based on a particle-enhanced turbidimetric inhibiti… | 1994 |
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K972929.
How does its category compare?
All DCF devicesDCF Albumin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Dade Behring Dimension® Microalbumin (MALB) Flex® reagent cartridge method is an in vitro diagnostic test intended to quantitatively measure albumin in human urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. Measurement also aids in the diagnosis and treatment of heart diseases or thyroid disorders which are characterized by proteinuria or albuminuria.
The Dade Behring Dimension® Microalbumin Calibrator is an in vitro diagnostic device intended for use on Dade Behring Dimension® clinical chemistry systems for medical purposes to establish points of reference that are used in the determination of albumin in urine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033525: Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114, DC114.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033525
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