# K101089: Easyra Micro-Albumin Reagent and Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Jul 13, 2011 after 450 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
The EasyRA pALB reagent is intended for the quantitative determination of micro-albumin in human urine, using the MEDICA 'EasyRA Chemistry Analyzer" in clinical laboratories. Micro-albumin measurements using immunological tests aid in the diagnosis of kidney diseases. The EasyRA micro-albumin (pALB) calibrator facilitates measurements of pALB on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's pALB reagent. The pALB calibrator is used to establish points of reference that are used in the determination of values in the measurement of pALB in human urine.

Source page: https://510kreport.com/device/K101089
Methodology: https://510kreport.com/methodology