# K103387: Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip Urine Control

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Feb 2, 2011 after 76 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070848: Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435X, Bio-Rad, Diagnostics Grp. (2007) Summary page 2.
- K931467: Chek-Stix Control Strips for Urinalysis, Heraeus Kulzer, Inc. (1993) Summary page 2.

## Most influential descendants
- 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 Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are assayed urine controls intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.

Source page: https://510kreport.com/device/K103387
Methodology: https://510kreport.com/methodology