510(k) · Cleared
Recalled · Class II · 2025Alinity C Glucose Reagent Kit, Alinity C System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CFR Hexokinase, Glucose
Cleared on Oct 19, 2017 as substantially equivalent to K060383 (Abbott Laboratories, 2006) and 1 other predicate after a 260-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 19, 2017
- Review
- 260 days
- Class
- Class II
- Product code
- CFR
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K872494 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK872494 Hitachi 717 Chemistry AnalyzerBoehringer Mannheim Corp. · 1987
- 1 generation backK980367 Aeroset SystemAbbott Laboratories · 1998 · Recalled
- This deviceK170316 Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories · 2017
- Descendant · cites it directly · 0 of its ownK230790 Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit…Abbott Laboratories · 2023
Most influential descendants
Showing 1 of 1 · See all- K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…Abbott Laboratories · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872494 | Hitachi 717 Chemistry Analyzer | Boehringer Mannheim Corp. | 1987 | — |
| −1 | K980367 | Aeroset System | Abbott Laboratories | 1998 | 34 |
| 0 (this device) | K170316 | Alinity C Glucose Reagent Kit, Alinity C System | Abbott Laboratories | 2017 | — |
| +1 | K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c… | Abbott Laboratories | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K060383 | GlucoseSummary page 6…iscrete photometric chemistry analyzer for clinical use Governing Regulation: CFR 862.2160 Product Code: JJE III. Predicate Device Reagent Glucose (k060383) Instrument AEROSET/ARCHITECT c System family members (k980367) k170316 Alinity c Glucose Reagent Kit; Alinity… | 2006 |
| * | K980367 | Aeroset SystemSummary page 6…ulation: CFR 862.2160 Product Code: JJE III. Predicate Device Reagent Glucose (k060383) Instrument AEROSET/ARCHITECT c System family members (k980367) k170316 Alinity c Glucose Reagent Kit; Alinity c System Page 2 IV. Description… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample… | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2025 | Class II | Z-0961-2026 | Software design | Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 19.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K230790 (Abbott Laboratories, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K060383.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. 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 Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170316: Alinity C Glucose Reagent Kit, Alinity C System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170316
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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