510(k) · Cleared
ClearedVITROS Chemistry Products GLU Slides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Clinical Diagnostics · CGA Glucose Oxidase, Glucose
Cleared on Sep 18, 2017 as substantially equivalent to K955286 (Johnson & Johnson Clinical Diagnostics, Inc., 1996) after a 285-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Sep 18, 2017
- Review
- 285 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955286 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK955286 Ektachem Clinical Chemistry Slide Glucose (Glu)Johnson & Johnson Clinical Diagnostics, Inc. · 1996 · Recalled
- This deviceK163433 VITROS Chemistry Products GLU SlidesOrtho Clinical Diagnostics · 2017
- Descendant · cites it directly · 1 of its ownK182072 VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK190520 VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955286 | Ektachem Clinical Chemistry Slide Glucose (Glu) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996 | 7 |
| 0 (this device) | K163433 | VITROS Chemistry Products GLU Slides | Ortho Clinical Diagnostics | 2017 | — |
| +1 | K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 2 |
| +2 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 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? (1)
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 |
|---|---|---|---|
| * | K955286 | Ektachem Clinical Chemistry Slide Glucose (Glu)Summary page 4…fied) are substantially equivalent to the VITROS® Chemistry Products GLU Slides (current). The FDA cleared the VITROS® Chemistry Products GLU Slides on May 17, 1996 (k955286). Reason for 510(k) submission The device modification is a proportional reduction in the amount of reagent used to manufa… | 1996 |
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 |
|---|---|---|---|
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS… | 2018 | 1 |
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?
- Its one ancestor has a recall.
- Of its descendants, K182072 (Ortho-Clinical Diagnostics, Inc., 2018) has gone furthest, with 1 descendant 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. 2017, this device’s year, is highlighted.
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 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides are used on VITROS Systems to quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163433: VITROS Chemistry Products GLU Slides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163433
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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