# K091486: K-Assay Microalbumin and K-Assay Microalbumin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Apr 29, 2010 after 345 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 K-ASSAY® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction. FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY® Microalbumin Calibrator is for the calibration of the K-ASSAY® Microalbumin assay for quantifying albumin in urine specimens. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K091486
Methodology: https://510kreport.com/methodology