# K082251: Synchron Systems Microalbumin (MA) Reagent, Model 475100

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 8, 2009 after 243 days
- Product code: DCF (Albumin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) IMMAGE Immunochemistry Systems Microalbumin Reagent: named in the summary without a submission number

## Most influential descendants
- K142346: Urine/CSF Albumin, Urine/CSF Albumin Calibrator (2014), 0 descendants of its own

## Recalls of this device
- Apr 24, 2017 · Class II · Z-2124-2017: Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.

## Indications for use
MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.

Source page: https://510kreport.com/device/K082251
Methodology: https://510kreport.com/methodology