510(k) · Cleared
Recalled · Class II · 2018Kodak Ektachem Clinical Chemistry Slide Phenytoin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · DIP Enzyme Immunoassay, Diphenylhydantoin
Cleared on Jun 13, 1994 after a 95-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 13, 1994
- Review
- 95 days
- Class
- Class II
- Product code
- DIP
- Recalls
- 5
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK941142 Kodak Ektachem Clinical Chemistry Slide PhenytoinEastman Kodak Company · 1994
- Descendant · cites it directly · 3 of its ownK081543 Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators…Ortho-Clinical Diagnostics, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK182063 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK190326 VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK083173 Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators…Ortho-Clinical Diagnostics · 2008 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K081543Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600…Ortho-Clinical Diagnostics, Inc. · 2008 · cites it directly3descendants
- K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…Ortho-Clinical Diagnostics, Inc. · 2018 · 2 generations on1descendant
- K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · 3 generations on0descendants
- K083173Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600…Ortho-Clinical Diagnostics · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941142 | Kodak Ektachem Clinical Chemistry Slide Phenytoin | Eastman Kodak Company | 1994 | — |
| +1 | K081543 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600… | Ortho-Clinical Diagnostics, Inc. | 2008 | 39 |
| +2 | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 20 |
| +3 | K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
| +2 | K083173 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600… | Ortho-Clinical Diagnostics | 2008 | 26 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DIP? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K081543 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600… | 2008 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2018 | Class II | Z-2344-2018 | Under Investigation by firm | There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples. |
| Jun 12, 2017 | Class II | Z-0273-2018 | Device Design | The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin… |
| Sep 28, 2015 | Class III | Z-0202-2016 | Under Investigation by firm | The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954. |
| Aug 20, 2014 | Class II | Z-0007-2015 | Software Manufacturing/Software Deployment | Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot… |
| Jun 12, 2013 | Class II | Z-0321-2014 | 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?
- Of its descendants, K081543 (Ortho-Clinical Diagnostics, Inc., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DIP devicesDIP Enzyme Immunoassay, Diphenylhydantoin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIP
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · DIP
Too few DIP 510(k)s in any year since 2007 to give a median.
Recalls per year · DIP
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIP
2in 2025
MAUDE reports naming product code DIP, 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 | 2 |
| 2008 | 1 | — | 1 | 20 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 59 |
| 2011 | 0 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 51 |
| 2013 | 0 | — | 3 | 163 |
| 2014 | 0 | — | 2 | 57 |
| 2015 | 0 | — | 0 | 65 |
| 2016 | 0 | — | 0 | 69 |
| 2017 | 0 | — | 1 | 55 |
| 2018 | 0 | — | 0 | 79 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 17 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 42 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K941142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941142: Kodak Ektachem Clinical Chemistry Slide Phenytoin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941142
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026