510(k) · Cleared
ClearedVitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit, Models CI-DT Slides:131 4905
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · CGZ Electrode, Ion-Specific, Chloride
Cleared on Aug 21, 2008 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) and 1 other predicate after a 27-day review. Its family tree reaches back 3 generations to 1988. 3 later devices descend from it.
- Decided
- Aug 21, 2008
- Review
- 27 days
- Class
- Class II
- Product code
- CGZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K875191 (1988). 5 ancestors in all, the oldest K870035 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK875191 Kodak Ektachem DT Slides (CRSC)Eastman Kodak Company · 1988
- 2 generations backK071216 Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- 1 generation backK072443 Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- This deviceK082099 Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK083680 Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2009 · cites it directly2descendants
- K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · 2 generations on1descendant
- K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875191 | Kodak Ektachem DT Slides (CRSC) | Eastman Kodak Company | 1988 | — |
| −2 | K071216 | Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2007 | 1 |
| −1 | K072443 | Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA Assay | Ortho-Clinical Diagnostics, Inc. | 2007 | 1 |
| 0 (this device) | K082099 | Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT… | Ortho-Clinical Diagnostics, Inc. | 2008 | — |
| +1 | K083680 | Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2009 | 1 |
| +2 | K091861 | Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2009 | — |
| +3 | 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 | 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 CGZ? 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 |
|---|---|---|---|
| * | K912844 | Kodak Ektachem Dtii SystemSummary page 1…VITROS Chemistry device Products DT Calibrator Kit are substantially equivalent to the VITROS Chemistry Products Clf DT Slides (current slide: K912844, cleared September 4, 1991) and VITROS Chemistry Products DT Calibrator Kit (Current Kit: K072443, cleared… | 1991 |
| * | K072443 | Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA AssaySummary page 1…Products Clf DT Slides (current slide: K912844, cleared September 4, 1991) and VITROS Chemistry Products DT Calibrator Kit (Current Kit: K072443, cleared September 24, 2007). Continue… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083680 | Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit… | 2009 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K083680 (Ortho-Clinical Diagnostics, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 28 other devices also cite its predicate K912844.
How does its category compare?
All CGZ devicesCGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · CGZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CGZ
Too few CGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGZ
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGZ
5in 2025
MAUDE reports naming product code CGZ, 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 | — | 1 | 4 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 19 |
| 2019 | 0 | — | 2 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS CI- DT Slides quantitatively measure chloride (Cl-) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
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+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082099: Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit, Models CI-DT Slides:131 4905.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082099
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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