510(k) · Cleared
ClearedGlucose
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CFR Hexokinase, Glucose
Cleared on May 5, 2006 as substantially equivalent to K953847 (Roche Diagnostic Systems, Inc., 1996) after an 80-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- May 5, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953847 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953847 Roche Reagent for GlucoseRoche Diagnostic Systems, Inc. · 1996
- This deviceK060383 GlucoseAbbott Laboratories · 2006
- Descendant · cites it directly · 1 of its ownK170316 Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK252357 Glucose2Abbott Ireland · 2025
- Descendant · 2 generations on · 0 of its ownK230790 Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit…Abbott Laboratories · 2023
Most influential descendants
Showing 3 of 3 · See all- K170316Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories · 2017 · cites it directly1descendant
- K252357Glucose2Abbott Ireland · 2025 · cites it directly0descendants
- K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…Abbott Laboratories · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953847 | Roche Reagent for Glucose | Roche Diagnostic Systems, Inc. | 1996 | — |
| 0 (this device) | K060383 | Glucose | Abbott Laboratories | 2006 | — |
| +1 | K170316 | Alinity C Glucose Reagent Kit, Alinity C System | Abbott Laboratories | 2017 | 1 |
| +1 | K252357 | Glucose2 | Abbott Ireland | 2025 | — |
| +2 | K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c… | Abbott Laboratories | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K953847 | Roche Reagent for GlucoseSummary page 2…Page I Substantial Equivalence: The Glucose assay is substantially equivalent to the Glucose/HK assay (K953847) on the Hitachi 917 Analyzer. Both assays yield similar Performance Characteristics. Similarities: * Both assays are in… | 1996 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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/K060383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060383: Glucose.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060383
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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