510(k) · Cleared
ClearedCreatinine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Apr 7, 2009 as substantially equivalent to K061193 (Abbott Laboratories, Inc., 2006) and 1 other predicate after a 106-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Apr 7, 2009
- Review
- 106 days
- Class
- Class II
- Product code
- CGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K941837 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK941837 Roche Reagent for CreatinineRoche Diagnostic Systems, Inc. · 1994
- 1 generation backK061193 CreatinineAbbott Laboratories, Inc. · 2006
- This deviceK083809 CreatinineAbbott Laboratories · 2009
- Descendant · cites it directly · 0 of its ownK210452 Creatinine2Abbott Ireland Diagnostics Division · 2022
Most influential descendants
Showing 1 of 1 · See all- K210452Creatinine2Abbott Ireland Diagnostics Division · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941837 | Roche Reagent for Creatinine | Roche Diagnostic Systems, Inc. | 1994 | — |
| −1 | K061193 | Creatinine | Abbott Laboratories, Inc. | 2006 | — |
| 0 (this device) | K083809 | Creatinine | Abbott Laboratories | 2009 | — |
| +1 | K210452 | Creatinine2 | Abbott Ireland Diagnostics Division | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 CGX? 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 CGX device
- #1 K242685 Atellica® CH Creatinine_3 (Crea3)score 12.1 · 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 |
|---|---|---|---|
| * | K061193 | CreatinineSummary page 2…n of creatinine in the sample. Substantial Equivalence: The modified Creatinine assay is substantially equivalent to the cleared Creatinine assay (K061193) on the Abbott AEROSET® System and ARCHITECT® cSystems. The modifications to the urine application include changes to the calib… | 2006 |
| * | K941837 | Roche Reagent for CreatinineSummary page 2…he Performance Characteristics Summary. The modified Creatinine assay urine application is substantially equivalent to the Roche Creatinine assay urine application (K941837) on the Hitachi 917 Analyzer. Both assays yield similar Performance Characteristics. Similarities: Both assays can b… | 1994 |
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 |
|---|---|---|---|
| K210452 | Creatinine2 | 2022 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210452 (Abbott Ireland Diagnostics Division, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGX
25in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGX
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGX
34in 2025
MAUDE reports naming product code CGX, 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 | 4 | 25 | 0 | 15 |
| 2008 | 0 | — | 1 | 27 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 1 | — | 2 | 13 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 2 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
A creatinine test system is a device intended to measure creatinine levels in serum,
plasma and urine. Creatinine measurements are used in the diagnosis and treatment of
renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other
urine analytes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083809: Creatinine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083809
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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