# K051191: DCL Microalbumin Assay, Model 252-20

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Jul 5, 2005 after 56 days
- Product code: DCF (Albumin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K051191
Methodology: https://510kreport.com/methodology