510(k) · Cleared
Recalled · Class III · 2013Mas Liquid Urinalysis Control Level 1, Level 2 and Level 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Analysis Systems, Inc. · JJW Urinalysis Controls (Assayed And Unassayed)
Cleared on Sep 29, 1997 after an 18-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Sep 29, 1997
- Review
- 18 days
- Class
- Class I
- Product code
- JJW
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2013 | Class III | Z-0383-2014 | Under Investigation by firm | 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. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JJW devicesJJW Urinalysis Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJW
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJW
Too few JJW 510(k)s in any year since 2007 to give a median.
Recalls per year · JJW
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJW
1in 2022
MAUDE reports naming product code JJW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 7 | 1 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 2 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (130 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973451: Mas Liquid Urinalysis Control Level 1, Level 2 and Level 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973451
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026