510(k) · Cleared
ClearedAdvia Chemistry Gluh_3 Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CFR Hexokinase, Glucose
Cleared on May 15, 2012 as substantially equivalent to K101854 (Siemens Healthcare Diagnostics, 2011) after a 70-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- May 15, 2012
- Review
- 70 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042015 (2004). No later device cites it as a predicate yet.
- Root · 2 generations backK042015 Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose…Bayer Healthcare, Diagnostics Division · 2004 · Recalled
- 1 generation backK101854 Advia Chemistry Glucose Hexokinase_3 (Gluh_3) Reagent, Models Ref…Siemens Healthcare Diagnostics · 2011
- This deviceK120681 Advia Chemistry Gluh_3 ReagentsSiemens Healthcare Diagnostics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042015 | Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose Hexokinase | Bayer Healthcare, Diagnostics Division | 2004 | 1 |
| −1 | K101854 | Advia Chemistry Glucose Hexokinase_3 (Gluh_3) Reagent, Models Ref 05001429 | Siemens Healthcare Diagnostics | 2011 | — |
| 0 (this device) | K120681 | Advia Chemistry Gluh_3 Reagents | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
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 CFR? 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 CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 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 |
|---|---|---|---|
| * | K101854 | Advia Chemistry Glucose Hexokinase_3 (Gluh_3) Reagent, Models Ref 05001429Summary page 1…) Device Regulation Product number Class _____ Code ADVIA® ADVIA® k101854 Class If 862.1345 CFR Chemistry Chemistry GLUH_3 Reagent GLUH_3 Reagent (additional Device Description: Th… | 2011 |
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 8 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, 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 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use in the quantitative determination of glucose in human serum,
plasma, urine and CSF on the ADVIA Chemistry systems. Such measurements are used
in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes
mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, ahd insulin overdose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120681 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120681: Advia Chemistry Gluh_3 Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120681
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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