510(k) · Cleared
Recalled · Class II · 2016Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose Hexokinase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, Diagnostics Division · CGA Glucose Oxidase, Glucose
Cleared on Sep 29, 2004 after a 64-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 29, 2004
- Review
- 64 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK042015 Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose…Bayer Healthcare, Diagnostics Division · 2004
- Descendant · cites it directly · 1 of its ownK101854 Advia Chemistry Glucose Hexokinase_3 (Gluh_3) Reagent, Models Ref…Siemens Healthcare Diagnostics · 2011
- Descendant · 2 generations on · 0 of its ownK120681 Advia Chemistry Gluh_3 ReagentsSiemens Healthcare Diagnostics, Inc. · 2012
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 |
|---|---|---|---|---|---|
| 0 (this device) | K042015 | Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose Hexokinase | Bayer Healthcare, Diagnostics Division | 2004 | — |
| +1 | K101854 | Advia Chemistry Glucose Hexokinase_3 (Gluh_3) Reagent, Models Ref 05001429 | Siemens Healthcare Diagnostics | 2011 | — |
| +2 | K120681 | Advia Chemistry Gluh_3 Reagents | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | — | Roche Glucose Hexokinase Named without a submission number |
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 |
|---|---|---|---|
| K101854 | Advia Chemistry Glucose Hexokinase_3 (Gluh_3) Reagent, Models Ref 05001429 | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2016 | Class II | Z-1655-2016 | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101854 (Siemens Healthcare Diagnostics, 2011) 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.
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?
The Bayer ADVIA® 1650 Glucose Hexokinase II assay is an in vitro diagnostic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma (lithium heparin), and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose. The Bayer…
Read the full statement (121 words)
The Bayer ADVIA® 1650 Glucose Hexokinase II assay is an in vitro diagnostic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma (lithium heparin), and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
The Bayer ADVIA® 1650 Glucose Oxidase assay is an in vitro diagnostic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042015 · printed Nov 3, 2026
Cite this page
510(k) Report. “K042015: Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose Hexokinase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K042015
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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