510(k) · Cleared
Recalled · Class III · 2013Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+DT Slides: 153 2258
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · CEM Electrode, Ion Specific, Potassium
Cleared on Feb 27, 2009 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 1988. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 27, 2009
- Review
- 77 days
- Class
- Class II
- Product code
- CEM
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K875191 (1988). 6 ancestors in all, the oldest K870035 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK875191 Kodak Ektachem DT Slides (CRSC)Eastman Kodak Company · 1988
- 3 generations backK071216 Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- 2 generations backK072443 Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- 1 generation backK082099 Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2008
- This deviceK083680 Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See all- K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · cites it directly1descendant
- K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K875191 | Kodak Ektachem DT Slides (CRSC) | Eastman Kodak Company | 1988 | — |
| −3 | K071216 | Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2007 | 1 |
| −2 | K072443 | Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA Assay | Ortho-Clinical Diagnostics, Inc. | 2007 | 1 |
| −1 | K082099 | Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT… | Ortho-Clinical Diagnostics, Inc. | 2008 | — |
| 0 (this device) | K083680 | Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2009 | — |
| +1 | K091861 | Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2009 | — |
| +2 | 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 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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 CEM? 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 CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 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 |
|---|---|---|---|
| * | K912844 | Kodak Ektachem Dtii SystemSummary page 4…ducts DT Calibrator Kit, which were Cleared by the FDA for in vitro diagnostic use. VITROS Chemistry Products K+DT Slide: (K912844, cleared September 4, 1991) VITROS Chemistry Products DT Calibrator Kit:(K082099, cleared August 21, 2008)… | 1991 |
| * | K082099 | Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit…Summary page 4…e. VITROS Chemistry Products K+DT Slide: (K912844, cleared September 4, 1991) VITROS Chemistry Products DT Calibrator Kit:(K082099, cleared August 21, 2008). Table 1 lists the characteristics of the tests performed using the VITROS K+ S… | 2008 |
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 |
|---|---|---|---|
| K091861 | Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model… | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2013 | Class III | Z-1614-2013 | Employee error | While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process. |
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 11 months on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K091861 (Ortho-Clinical Diagnostics, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 28 other devices also cite its predicate K912844.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, 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 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
VITROS Chemistry Products K + DT Slides quantitatively measure potassium (K +) concentration in serum and plasma using VITROS.DT60 and DT60 II Chemistry Systems. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases or conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as…
Read the full statement (116 words)
VITROS Chemistry Products K + DT Slides quantitatively measure potassium (K +) concentration in serum and plasma using VITROS.DT60 and DT60 II Chemistry Systems. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases or conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only.
VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NI-3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083680: Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+DT Slides: 153 2258.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083680
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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