# K030320: Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Apr 11, 2003 after 71 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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. The FDA summary names its predicate without a number.
- (no number) Wako Micro Albumin B assay: named in the summary without a submission number

## Indications for use
A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

Source page: https://510kreport.com/device/K030320
Methodology: https://510kreport.com/methodology