510(k) · Cleared
Recalled · Class II · 2013Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Dec 10, 2002 as substantially equivalent to K861386 (Eastman Kodak Company, 1986) and 1 other predicate after a 19-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 10, 2002
- Review
- 19 days
- Class
- Class II
- Product code
- JIX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K861386 (1986). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK861386 Kodak Ektachem Clinical Chemistry Slides (MG)Eastman Kodak Company · 1986 · Recalled
- This deviceK023876 Vitros Chemistry Products MG Slide, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK072440 Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK190520 VITROS XT Chemistry Products GLU-Ca 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 | K861386 | Kodak Ektachem Clinical Chemistry Slides (MG) | Eastman Kodak Company | 1986 | 1 |
| 0 (this device) | K023876 | Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1 | Ortho-Clinical Diagnostics, Inc. | 2002 | — |
| +1 | K072440 | Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1… | Ortho-Clinical Diagnostics, Inc. | 2007 | 4 |
| +2 | K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 JIX? 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 |
|---|---|---|---|
| * | K861386 | Kodak Ektachem Clinical Chemistry Slides (MG)Summary page 3…ucts Mg Slide and VITROS Chemistry Products Calibrator Kit device 1 that were cleared by the FDA for in vitro diagnostic use. Mg Slide: (K861386, Cleared August 26, 1986) Calibrator Kit 1: (KO01885 Cleared July 20,2000) Table 1 lists… | 1986 |
| * | K001885 | Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1 | 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 |
|---|---|---|---|
| K072440 | Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188… | 2007 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2013 | Class II | Z-0318-2014 | 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?
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
VITROS Chemistry Products Mg Slides
For in vitro diagnostic use only.
VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine.
VITROS Calibrator Kit 1
For in vitro diagnostic use only.
VITROS Calibrator Kit 1 is intended for use in calibration of the 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/K023876 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023876: Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023876
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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