# K161527: Teco Creatinine Enzymatic Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics, Inc.
- Decided: Jul 21, 2017 after 414 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: 2 generations back to K941837 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050283: Creatinine Liquicolor, Stanbio Laboratory (2005) Summary page 6.

## Indications for use
Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination or estimation of creatinine clearance or glomerular filtration rate (GFR).

Source page: https://510kreport.com/device/K161527
Methodology: https://510kreport.com/methodology