510(k) Report

510(k) · Cleared

Cleared

Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis Control

K023928510(k) TraditionalCleared Dec 11, 200216-day reviewClass I21 CFR 862.1660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Analysis Systems, Inc. · JJW Urinalysis Controls (Assayed And Unassayed)

Cleared on Dec 11, 2002 after a 16-day review. The FDA summary names no predicate by number. 3 later devices descend from it.

Decided
Dec 11, 2002
Review
16 days
Class
Class I
Product code
JJW
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared200020052010201520202025
  1. This deviceK023928 Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed…Medical Analysis Systems, Inc. · 2002
  2. Descendant · cites it directly · 1 of its ownK131444 UA-Cellular CompleteStreck · 2014
  3. Descendant · 2 generations on · 0 of its ownK170091 UA-Cellular CompleteStreck · 2017
  4. Descendant · cites it directly · 0 of its ownK060215 Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002Eurotrol B.V. · 2006

Most influential descendants

Showing 3 of 3 · See all
  • K131444UA-Cellular CompleteStreck · 2014 · cites it directly1descendant
  • K170091UA-Cellular CompleteStreck · 2017 · 2 generations on0descendants
  • K060215Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002Eurotrol B.V. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023928Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis…Medical Analysis Systems, Inc.2002—
+1K131444UA-Cellular CompleteStreck2014—
+2K170091UA-Cellular CompleteStreck2017—
+1K060215Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002Eurotrol B.V.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201410
201710
FIG. 1 — Lineage of K023928, 2002–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131444UA-Cellular CompleteStreck20141
K060215Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002Eurotrol B.V.20060

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K131444 (Streck, 2014) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JJW devices

JJW Urinalysis Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJW

1in 2017

2007: 22009: 12011: 22014: 12015: 12017: 1
2007high 2 (2007) · low 0 (2008)2026

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

2007: 12012: 72013: 12022: 22024: 2
2007high 7 (2012) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJW

1in 2022

2007: 22009: 12012: 12013: 242022: 1
2007high 24 (2013) · low 0 (2008)2025

MAUDE reports naming product code JJW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—12
20080—00
20091—01
20100—00
20112—00
20120—71
20130—124
20141—00
20151—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—21
20230—00
20240—20
20250—00
20260—0—

What is it indicated for?

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…

Read the full statement (170 words)

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.

Indications for use as stated in the FDA summary.

More from Medical Analysis Systems, Inc.

107 FDA decisions under this applicant name. See the company

  • K042717Mas, Dade and Liquid Assayed Diabetes ControlMedical Analysis Systems, Inc. · 2004
  • K041194Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and HMedical Analysis Systems, Inc. · 2004
  • K040880Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3Medical Analysis Systems, Inc. · 2004
  • K032826Mas Par TDMMedical Analysis Systems, Inc. · 2003
  • K032335Mas Cardioimmune Probnp, Mas Cardioimmune TLMedical Analysis Systems, Inc. · 2003

Recent decisions in JJW

The JJW category page

  • K170091UA-Cellular CompleteStreck · 2017
  • K142262Aution Check PlusQuantimetrix Corp. · 2015
  • K131444UA-Cellular CompleteStreck · 2014
  • K110846Randox Urinalysis Controls, Levels 1 and 2Randox Laboratories Limited · 20111 recall
  • K103387Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip Urine ControlACON Laboratories, Inc. · 2011

https://510kreport.com/device/K023928 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023928: Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023928

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026