# K061775: Wako L-Type Creatinine-M Test, and Wako Creatinine Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Feb 23, 2007 after 245 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K842847 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842847: Wako Automated Reagents for Hitachi 705, Wako Chemicals USA, Inc. (1984) Summary page 1.

## Indications for use
The L-Type Creatinine-M is an in-vitro assay for the quantitative determination of creatinine in serum, plasma, and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K061775
Methodology: https://510kreport.com/methodology