# K033860: Autokit Total Ketone Bodies Kit (Serum) and Wako Ketone Body Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Apr 23, 2004 after 133 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 Total Ketone Body Calibrators are intended to be used with the Wako Autokit Total Ketone Bodies and Wako Autokit 3-HB test kits to establish points of reference that are used in the determination of values in the measurement of total ketone bodies and 3-hydroxybutyrate in human serum or plasma.

Source page: https://510kreport.com/device/K033860
Methodology: https://510kreport.com/methodology