# K033525: Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114, DC114

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 12, 2004 after 66 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
Longest line of descent: 2 generations back to K895883 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972929: N Antiserum to Human Albumin, Behring Diagnostics, Inc. (1997) Summary page 1.
- K936201: Urinary Albumin Calibrator, Dupont Medical Products (1994) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K033525
Methodology: https://510kreport.com/methodology