# K973451: Mas Liquid Urinalysis Control Level 1, Level 2 and Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Sep 29, 1997 after 18 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 29, 2013 · Class III · Z-0383-2014: Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011.

## Indications for use
MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3 is a human urine based quality control material used in routine urinalysis testing performed in clinical laboratories. The product is formulated to contain Protein, Glucose Ketones, Bilirubin, Blood (hemoglobin), Nitrite, Urobilinogen, Leukocyte Esterase, Sodium, Potassium, Red Cells, White Cells, Crystals, Microalbumin, and Creatinine. The product insert contains assay values for these constituents as well as physical characteristics including pH, Appearance, Color, Specific Gravity, and Osmolality. MAS Liquid Urinalysis Control Level 1, Level 2, and Level 3 is used by the Clinician as a quality control sample with known qualitative and semi-quantitative values for each of the listed constituents, physical characteristics and assay methodologies. This allows the Clinician to monitor and control the quality of the laboratory urinalysis testing results.

Source page: https://510kreport.com/device/K973451
Methodology: https://510kreport.com/methodology