# K040226: Wako Auto Kit Prealbumin, Wako Autokit Prealbumin Calibrator Set, Prealbumin Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Mar 25, 2004 after 52 days
- Product code: JIT (Calibrator, Secondary)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Wako Prealbumin Calibrator Set is intended to be used in the Wako Prealbumin Test System to establish points of reference that are to be used in determination of values in the measurement of prealbumin in human serum or plasma. The Wako Prealbumin Control Set is intended to be used in the Wako Prealbumin Test System to estimate test precision and detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Source page: https://510kreport.com/device/K040226
Methodology: https://510kreport.com/methodology