# K070929: Acon U120 Urine Analyzer, Model U111-101

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Jul 30, 2007 after 118 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- 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 K905396 (1991). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 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 2.

## Most influential descendants
- K111221: Mission U500 Urine Analyzer (2012), 1 descendant of its own
- K173327: DIP/U.S. Urine Analysis Test System (2018), 0 descendants of its own
- K142543: Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control (2015), 0 descendants of its own

## Indications for use
The ACON TM U120 Urine Analyzer is intended for use in conjunction with the ACON Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The ACON Urinalysis Reagent Strips are available in different combinations of the aforementioned analytes. The instrument is intended for professional, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.

Source page: https://510kreport.com/device/K070929
Methodology: https://510kreport.com/methodology