510(k) · Cleared
Recalled · Class II · 2018Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros Chemistry Products Calibrator Kit 1,Model#1882208
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JFY Enzymatic Method, Creatinine
Cleared on Dec 15, 2006 as substantially equivalent to K001310 (Ortho-Clinical Diagnostics, Inc., 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 15, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- JFY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001310 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001310 Vitros Chemistry Products Crea Slide, Virtros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2000
- This deviceK063591 Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros…Ortho-Clinical Diagnostics, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK182063 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK190326 VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001310 | Vitros Chemistry Products Crea Slide, Virtros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2000 | — |
| 0 (this device) | K063591 | Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros Chemistry… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
| +1 | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 20 |
| +2 | K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 JFY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFY device
- #1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K001310 | Vitros Chemistry Products Crea Slide, Virtros Chemistry Products Calibrator Kit 1Summary page 1…iginally cleared under the VITROS Chemistry Products CREA Slides and VITROS Chemistry Products Calibrator Kit1 Premarket Notification K001310. Continued on next page SPECIAL 5 10(K) SUBMIS… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS… | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2018 | Class III | Z-3193-2018 | Process control | The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for this assay. The… |
| Jun 12, 2013 | Class II | Z-0308-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K182063 (Ortho-Clinical Diagnostics, Inc., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JFY devicesJFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JFY
59in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFY
61in 2025
MAUDE reports naming product code JFY, 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 | 8 | 193 | 0 | 1 |
| 2008 | 4 | 170 | 2 | 4 |
| 2009 | 3 | 59 | 3 | 22 |
| 2010 | 0 | — | 3 | 22 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 1 | 39 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 61 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only.
VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine.
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. 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.
For in vitro diagnostic use only.
VITROS Calibrator Kit 1 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of BUN/UREA, Ca, CREA, GLU, LAC, LI, Mg, PHOS, SALI, THEO, and URIC.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063591: Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros Chemistry Products Calibrator Kit 1,Model#1882208.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063591
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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