510(k) · Cleared
Recalled · Class II · 2014Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA Assay
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 24, 2007 as substantially equivalent to K870035 (Eastman Kodak Company, 1987) and 1 other predicate after a 25-day review. Its family tree reaches back 2 generations to 1988. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 24, 2007
- Review
- 25 days
- Class
- Class II
- Product code
- CJY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K875191 (1988). 3 ancestors in all, the oldest K870035 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK875191 Kodak Ektachem DT Slides (CRSC)Eastman Kodak Company · 1988
- 1 generation backK071216 Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- This deviceK072443 Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and…Ortho-Clinical Diagnostics, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK082099 Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK083680 Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009
- Descendant · 4 generations on · 0 of its ownK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2008 · cites it directly3descendants
- K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2009 · 2 generations on2descendants
- K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · 3 generations on1descendant
- K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2010 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875191 | Kodak Ektachem DT Slides (CRSC) | Eastman Kodak Company | 1988 | — |
| −1 | K071216 | Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2007 | 1 |
| 0 (this device) | K072443 | Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA Assay | Ortho-Clinical Diagnostics, Inc. | 2007 | — |
| +1 | K082099 | Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT… | Ortho-Clinical Diagnostics, Inc. | 2008 | — |
| +2 | K083680 | Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2009 | 1 |
| +3 | K091861 | Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2009 | — |
| +4 | K093611 | Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT… | Ortho-Clinical Diagnostics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K870035 | Kodak Ektachem DT Slides (CA)Summary page 1…slide) and VITROS Chemistry Products DT Calibrator Kit. The FDA cleared the VITROS Chemistry Products Ca DT Slides on May 12, 1987 (K870035) Under the product name KODAK EKTACHEM DT SLIIDES (Ca). With the purchase of KODAK Clinical Products Division… | 1987 |
| * | K071216 | Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator Kit…Summary page 1…Chemistry Products Ca DT Slides The most recent FDA clearance for the VITROS Chemistry Products DT Calibrator Kit was May 25, 2007 (K071216). Continued on next page… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082099 | Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit… | 2008 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2014 | Class II | Z-2214-2014 | Process control | Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 19.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K082099 (Ortho-Clinical Diagnostics, Inc., 2008) has gone furthest, with 3 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 DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. 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 Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL; BUN/CREA, Ca, CHOL, CK, Cl-, C0 2 , CREA, CRSC, Fe, GGT, GLU, HDLC, K 4 , LAC, LDH, LIPA, Mg, Nat, NH-3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072443 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072443: Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072443
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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