510(k) · Cleared
Recalled · Class II · 2025Ektachem Clinical Chemistry Slide Glucose (Glu)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Clinical Diagnostics, Inc. · CGA Glucose Oxidase, Glucose
Cleared on May 17, 1996 after a 183-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled 7 times.
- Decided
- May 17, 1996
- Review
- 183 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 7
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK955286 Ektachem Clinical Chemistry Slide Glucose (Glu)Johnson & Johnson Clinical Diagnostics, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK163433 VITROS Chemistry Products GLU SlidesOrtho Clinical Diagnostics · 2017
- Descendant · 2 generations on · 1 of its ownK182072 VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK190520 VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See all- K163433VITROS Chemistry Products GLU SlidesOrtho Clinical Diagnostics · 2017 · cites it directly2descendants
- K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS…Ortho-Clinical Diagnostics, Inc. · 2018 · 2 generations on1descendant
- K190520VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955286 | Ektachem Clinical Chemistry Slide Glucose (Glu) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996 | — |
| +1 | K163433 | VITROS Chemistry Products GLU Slides | Ortho Clinical Diagnostics | 2017 | — |
| +2 | K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 2 |
| +3 | K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K163433 | VITROS Chemistry Products GLU Slides | 2017 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2025 | Class II | Z-2560-2025 | Device Design | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration… |
| Jul 29, 2025 | Class II | Z-2559-2025 | Device Design | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration… |
| Jun 17, 2019 | Class II | Z-2202-2019 | Process control | Potentially Biased Results using VITROS Chemistry Products GLU Slides |
| Aug 11, 2016 | Class II | Z-0089-2017 | Under Investigation by firm | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays. Ortho… |
| Aug 11, 2016 | Class II | Z-0090-2017 | Under Investigation by firm | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays. |
| Jun 12, 2013 | Class II | Z-0314-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| Jul 28, 2003 | Not classified | Z-1224-03 | Other | Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163433 (Ortho Clinical Diagnostics, 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K955286 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955286: Ektachem Clinical Chemistry Slide Glucose (Glu).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955286
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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