510(k) · Cleared
Recalled · Class II · 2013Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Dec 10, 2002 as substantially equivalent to K812030 (Eastman Kodak Company, 1981) and 1 other predicate after a 19-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 10, 2002
- Review
- 19 days
- Class
- Class II
- Product code
- CIX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K812030 (1981). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK812030 Kodak Ektachem Clin. Chem. Slides (Alb)Eastman Kodak Company · 1981 · Recalled
- This deviceK023875 Vitros Chemistry Products Alb Slide, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK191316 VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K812030 | Kodak Ektachem Clin. Chem. Slides (Alb) | Eastman Kodak Company | 1981 | 1 |
| 0 (this device) | K023875 | Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4 | Ortho-Clinical Diagnostics, Inc. | 2002 | — |
| +1 | K191316 | VITROS XT Chemistry Products ALB-TP Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 CIX? 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 CIX device
- #1 K251157 Core Metabolicscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K812030 | Kodak Ektachem Clin. Chem. Slides (Alb)Summary page 3…Slide and VITROS Chemistry Products Calibrator Kit 4 which were cleared by the FDA for in vitro diagnostic use. ALB Slide: (K812030, Cleared August 3,1981) Calibrator Kit 4: (K922072, July 19, 1992). Table 1 lis… | 1981 |
| * | K922072 | Kodak Ektachem 250 AnalyerSummary page 2…Multiple VITROS Chemistry Systems were cleared for market by separate 5 1O(k) pre-market notifications (K890928, K890929, K922072, K946090 and K922072). The VITROS Chemistry System and Calibrators are dedicated specifically for… | 1992 |
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 |
|---|---|---|---|
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | 2019 | 0 |
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-0294-2014 | 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?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K191316 (Ortho-Clinical Diagnostics, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CIX devicesCIX Bromcresol Green Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIX
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CIX
168in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIX
4in 2025
MAUDE reports naming product code CIX, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 74 |
| 2011 | 3 | 168 | 0 | 8 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
VITROS Chemistry Products ALB Slides
For in vitro diagnostic use only.
VITROS ALB Slides quantitatively measure albumin (ALB) concentration in serum and plasma.
VITROS Calibrator Kit 4
For in vitro diagnostic use only.
VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023875: Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023875
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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