510(k) · Cleared
ClearedUA-Cellular Complete
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck · JJW Urinalysis Controls (Assayed And Unassayed)
Cleared on Jan 29, 2014 as substantially equivalent to K023928 (Medical Analysis Systems, Inc., 2002) and 1 other predicate after a 254-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Jan 29, 2014
- Review
- 254 days
- Class
- Class I
- Product code
- JJW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K900484 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK900484 Ret-CheckStreck Laboratories, Inc. · 1990
- 3 generations backK961054 Sysmex UF-100Sysmex Corp. · 1996
- 2 generations backK070910 Sysmex Model UF1000ISysmex America, Inc. · 2007
- 1 generation backK080887 Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis…Sysmex America, Inc. · 2008 · Recalled
- This deviceK131444 UA-Cellular CompleteStreck · 2014
- Descendant · cites it directly · 0 of its ownK170091 UA-Cellular CompleteStreck · 2017
Most influential descendants
Showing 1 of 1 · See all- K170091UA-Cellular CompleteStreck · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900484 | Ret-Check | Streck Laboratories, Inc. | 1990 | — |
| −3 | K961054 | Sysmex UF-100 | Sysmex Corp. | 1996 | — |
| −2 | K070910 | Sysmex Model UF1000I | Sysmex America, Inc. | 2007 | — |
| −1 | K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software | Sysmex America, Inc. | 2008 | 1 |
| 0 (this device) | K131444 | UA-Cellular Complete | Streck | 2014 | — |
| +1 | K170091 | UA-Cellular Complete | Streck | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023928 | Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis ControlSummary page 1…Urinalysis Control Product Code: JJW (862.1660) Panel: Clinical Chemistry Predicate Device: Primary Predicate- MAS UA Control (K023928) Secondary Predicate- Sysmex UF 11CONTROLTM-K080887 Note: This product was cleared with the 510(k) for the Sysmex UF-1000i instr… | 2002 |
| * | K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareSummary page 1…(862.1660) Panel: Clinical Chemistry Predicate Device: Primary Predicate- MAS UA Control (K023928) Secondary Predicate- Sysmex UF 11CONTROLTM-K080887 Note: This product was cleared with the 510(k) for the Sysmex UF-1000i instrument (K080887) Intended Use: Intended Use: UA-Cell… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170091 | UA-Cellular Complete | 2017 | 0 |
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K170091 (Streck, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023928.
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. 2014, this device’s year, is highlighted.
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?
UA-Cellular Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the Sysmex® UP-1000i Automated Urine Particle Analyzer and the Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak. The list of assayed parameters includes: Sysmex UF-1000i:RBC(/µL), WBC(/µL), Epithelial (/µL)…
Read the full statement (108 words)
UA-Cellular Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the Sysmex® UP-1000i Automated Urine Particle Analyzer and the Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak.
The list of assayed parameters includes:
Sysmex UF-1000i:RBC(/µL), WBC(/µL), Epithelial (/µL), Cast, Bacteria (/pL), Crystals, Conductivity (mS/cm)
Siemens Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131444: UA-Cellular Complete.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131444
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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