510(k) · Cleared
ClearedDCL Microalbumin Assay, Model 252-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · DCF Albumin, Antigen, Antiserum, Control
Cleared on Jul 5, 2005 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 5, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- DCF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
For the quantitative determination of low levels of albumin in urine. For IN VITRO diagnostic use. Low levels of protein are normally excreted in the urine of healthy individuals. The uriniferous tubules and glomeruli filter out mr ' of these excreted mucoproteins. Albumin, a protein of molecular weight of 50,000, is not easily filtered out and small av its are excreted into the urine. Increased excretion of albumin (microalbuminuria) is an early…
Read the full statement (178 words)
For the quantitative determination of low levels of albumin in urine.
For IN VITRO diagnostic use.
Low levels of protein are normally excreted in the urine of healthy individuals. The uriniferous tubules and glomeruli filter out
mr ' of these excreted mucoproteins. Albumin, a protein of molecular weight of 50,000, is not easily filtered out and small
av its are excreted into the urine. Increased excretion of albumin (microalbuminuria) is an early indicator of glomerular
disease (1,2).
Microalbuminuria is characterized by increased urinary excretion of albumin in the absence of overt nephropathy (3,4).
Microalbuimin is recognized as a strong predictor of impending nephropathy in Type I Diabetics and its mortality risk in diabetic
patients (5). Early detection of microalbuminuria may be beneficial for treatment programs for diabetics because renal damage
may be reversible if diabetes is well controlled at this stage.
Many of the methods traditionally used for measuring albumin lack the sensitivity and precision required for measuring
microalbumin. The DCL Microalbumin Assay uses an immunoturbidimetric format which provides the sensitivity required for
accurate determination of urinary microalbumin.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051191: DCL Microalbumin Assay, Model 252-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051191
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026