# K023928: Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis Control

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Dec 11, 2002 after 16 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K131444: UA-Cellular Complete (2014), 1 descendant of its own
- K170091: UA-Cellular Complete (2017), 0 descendants of its own
- K060215: Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002 (2006), 0 descendants of its own

## Indications for use
MAS@UA Control is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis. DADE@UA Control is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.

Source page: https://510kreport.com/device/K023928
Methodology: https://510kreport.com/methodology