510(k) · Cleared
ClearedVITROS XT Chemistry Products GLU-Ca Slides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Apr 3, 2019 as substantially equivalent to K182072 (Ortho-Clinical Diagnostics, Inc., 2018) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Apr 3, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K861386 (1986). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK861386 Kodak Ektachem Clinical Chemistry Slides (MG)Eastman Kodak Company · 1986 · Recalled
- 2 generations backK023876 Vitros Chemistry Products MG Slide, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2002 · Recalled
- 1 generation backK072440 Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- This deviceK190520 VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861386 | Kodak Ektachem Clinical Chemistry Slides (MG) | Eastman Kodak Company | 1986 | 1 |
| −2 | K023876 | Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1 | Ortho-Clinical Diagnostics, Inc. | 2002 | 1 |
| −1 | K072440 | Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1… | Ortho-Clinical Diagnostics, Inc. | 2007 | 4 |
| 0 (this device) | K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS…Summary page 4…istry(75) Predicate Device(s) Predicate Devices FDA 510(k) Number VITROS Chemistry Products GLU Slides k182072 VITROS Chemistry Products Ca Slides k072440 1 ===… | 2018 |
| * | K072440 | Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188…Summary page 4…FDA 510(k) Number VITROS Chemistry Products GLU Slides k182072 VITROS Chemistry Products Ca Slides k072440 1 Intended Use Statement(s) VITROS XT Chemistry Products GLU-Ca… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- 11 of the 12 ancestors have a recall of any class.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 The GLU test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS XT 7600 Integrated Systems. 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…
Read the full statement (116 words)
For in vitro diagnostic use only
The GLU test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures glucose (GLU)
concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS XT 7600 Integrated Systems. 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.
The Ca test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures calcium (Ca)
concentration in serum, plasma, and urine using VITROS XT 7600 Integrated Systems. Calcium measurements are used
in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany
(intermittent muscular contractions or spasms).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190520: VITROS XT Chemistry Products GLU-Ca Slides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190520
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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