510(k) · Cleared
Recalled · Class II · 2025Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188 2208)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · CJY Azo Dye, Calcium
Cleared on Sep 20, 2007 as substantially equivalent to K961226 (Johnson & Johnson Clinical Diagnostics, Inc., 1996) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Sep 20, 2007
- Review
- 21 days
- Class
- Class II
- Product code
- CJY
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K861386 (1986). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK861386 Kodak Ektachem Clinical Chemistry Slides (MG)Eastman Kodak Company · 1986 · Recalled
- 1 generation backK023876 Vitros Chemistry Products MG Slide, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2002 · Recalled
- This deviceK072440 Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators…Ortho-Clinical Diagnostics, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK190520 VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190520VITROS XT Chemistry Products GLU-Ca 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 |
|---|---|---|---|---|---|
| −2 | K861386 | Kodak Ektachem Clinical Chemistry Slides (MG) | Eastman Kodak Company | 1986 | 1 |
| −1 | K023876 | Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1 | Ortho-Clinical Diagnostics, Inc. | 2002 | 1 |
| 0 (this device) | K072440 | Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1… | Ortho-Clinical Diagnostics, Inc. | 2007 | — |
| +1 | 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 |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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 CJY? 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 CJY device
- #1 K244042 Calcium2score 9.4 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K961226 | Ektachem Clinical Chemistry Calcium (CA) SlideSummary page 3…Products Calibrator Kit 1, which were Cleared by the FDA for in vitro diagnostic use. VITROS Chemistry Products Ca Slide: (K961226, cleared May 7, 1996) VITROS Chemistry Products Calibrator Kit l: (K023876, cleared December i0, 2002).… | 1996 |
| * | K023876 | Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1Summary page 3…ostic use. VITROS Chemistry Products Ca Slide: (K961226, cleared May 7, 1996) VITROS Chemistry Products Calibrator Kit l: (K023876, cleared December i0, 2002). Table I lists the characteristics of the tests performed using the VITROS Ca… | 2002 |
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 |
|---|---|---|---|
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2025 | Class II | Z-2335-2025 | Under Investigation by firm | Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results… |
| Apr 24, 2025 | Class II | Z-1831-2025 | Storage | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test… |
| May 18, 2016 | Class II | Z-2273-2016 | Nonconforming Material/Component | Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System. An… |
| Jun 12, 2013 | Class II | Z-0302-2014 | 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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 16.3 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K190520 (Ortho-Clinical Diagnostics, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CJY devicesCJY Azo Dye, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CJY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJY
Too few CJY 510(k)s in any year since 2007 to give a median.
Recalls per year · CJY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJY
59in 2025
MAUDE reports naming product code CJY, 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 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 4 | 8 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 1 | — | 2 | 21 |
| 2019 | 1 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 59 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).
For in vitro diagnostic use only. VITROS Calibrator Kit 1 is used to calibrate 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/K072440 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072440: Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188 2208).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072440
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