510(k) · Cleared
ClearedVITROS XT Chemistry Products UREA-CREA Slides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · CDN Urease, Photometric, Urea Nitrogen
Cleared on Mar 14, 2019 as substantially equivalent to K001885 (Ortho-Clinical Diagnostics, Inc., 2000) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Mar 14, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- CDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001310 (2000). 10 ancestors in all, the oldest K840880 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK001310 Vitros Chemistry Products Crea Slide, Virtros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2000
- 2 generations backK063591 Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
- 1 generation backK182063 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- This deviceK190326 VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001310 | Vitros Chemistry Products Crea Slide, Virtros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2000 | — |
| −2 | K063591 | Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros Chemistry… | Ortho-Clinical Diagnostics, Inc. | 2006 | 2 |
| −1 | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 20 |
| 0 (this device) | K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 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 CDN? 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 |
|---|---|---|---|
| * | K001885 | Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1Summary page 4…system Predicate Device(s) Predicate Devices FDA 510(k) Number VITROS Chemistry Products BUN/UREA Slides k001885 VITROS Chemistry Products CREA Slides k182063 1 === Pag… | 2000 |
| * | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…Summary page 4…FDA 510(k) Number VITROS Chemistry Products BUN/UREA Slides k001885 VITROS Chemistry Products CREA Slides k182063 1 Intended Use Statement(s) VITROS XT Chemistry Products UREA-CR… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 1 company; a new generation was cleared every 6.6 years on median.
- 8 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K001885.
How does its category compare?
All CDN devicesCDN Urease, Photometric, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · CDN
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · CDN
Too few CDN 510(k)s in any year since 2007 to give a median.
Recalls per year · CDN
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDN
2in 2015
MAUDE reports naming product code CDN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only The UREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures urea concentration, reported either as urea nitrogen or as urea (UREA), in serum, plasma, and urine using the VITROS XT 7600 Integrated System. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases The CREA test within the VITROS XT Chemistry Products UREA-CREA…
Read the full statement (114 words)
For in vitro diagnostic use only
The UREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures urea
concentration, reported either as urea nitrogen or as urea (UREA), in serum, plasma, and urine using the VITROS XT
7600 Integrated System. Measurements obtained by this device are used in the diagnosis and treatment of certain renal
and metabolic diseases
The CREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures creatinine
(CREA) concentration in serum, plasma, and urine using the VITROS XT 7600 Integrated System. Creatinine
measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation
basis for measuring other urine analytes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190326: VITROS XT Chemistry Products UREA-CREA Slides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190326
Report an extraction error
Are you the manufacturer?
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