# K142391: Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Dec 22, 2014 after 117 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: 4 generations back to K890577 (1989). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031947: Bayer Clinitek Status Analyzer, Bayer Healthcare, LLC (2003) Summary page 5.
- K972706: Clinitek Microalbumin Reagent Strips, Bayer Corp. (1997) Summary page 5.
- K070848: Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435X, Bio-Rad, Diagnostics Grp. (2007) Summary page 5.

## Most influential descendants
- K182384: ACR  LAB Urine Analysis Test System (2019), 1 descendant of its own
- K252619: Qscheck Uisacr (2026), 0 descendants of its own
- K232317: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips (2024), 0 descendants of its own

## Indications for use
The Mission® U120 Ultra Urine Analyzer is an urinalysis instrument intended for in vitro diagnostic use. It is intended for professional use only at point-of-care locations. The Mission U120 Ultra Urine Analyzer is intended to read Mission® Urinalysis Reagent strips (Microalbumin/Creatinine) for the semi quantitative measurement of Albumin and Creatinine. These measurements are used to assist diagnosis for kidney function. The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.

Source page: https://510kreport.com/device/K142391
Methodology: https://510kreport.com/methodology