510(k) · Cleared
ClearedCreatinine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories, Inc. · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Jun 23, 2006 as substantially equivalent to K941837 (Roche Diagnostic Systems, Inc., 1994) after a 56-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- CGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941837 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK941837 Roche Reagent for CreatinineRoche Diagnostic Systems, Inc. · 1994
- This deviceK061193 CreatinineAbbott Laboratories, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK083809 CreatinineAbbott Laboratories · 2009
- Descendant · 2 generations on · 0 of its ownK210452 Creatinine2Abbott Ireland Diagnostics Division · 2022
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 |
|---|---|---|---|---|---|
| −1 | K941837 | Roche Reagent for Creatinine | Roche Diagnostic Systems, Inc. | 1994 | — |
| 0 (this device) | K061193 | Creatinine | Abbott Laboratories, Inc. | 2006 | — |
| +1 | K083809 | Creatinine | Abbott Laboratories | 2009 | — |
| +2 | K210452 | Creatinine2 | Abbott Ireland Diagnostics Division | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K941837 | Roche Reagent for CreatinineSummary page 2…Page I Substantial Equivalence: The Creatinine assay is Substantially equivalent to the Roche Creathinie assay (K941837) on the Hitachi 917 Analyzer. Both assays yield similar Perfonnance Characteristics. Similarities: * Both assays ca… | 1994 |
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 |
|---|---|---|---|
| K083809 | Creatinine | 2009 | 1 |
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 CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/K061193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061193: Creatinine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061193
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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