510(k) · Cleared
ClearedCreatinine (Crea)
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 May 29, 1998 as substantially equivalent to K941837 (Roche Diagnostic Systems, Inc., 1994) and 1 other predicate after a 53-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- May 29, 1998
- Review
- 53 days
- Class
- Class II
- Product code
- CGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K812095 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK812095 Enxymatic Creatinine TestBoehringer Mannheim Corp. · 1981
- This deviceK981240 Creatinine (Crea)Abbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K812095 | Enxymatic Creatinine Test | Boehringer Mannheim Corp. | 1981 | — |
| 0 (this device) | K981240 | Creatinine (Crea) | Abbott Laboratories | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K941837 | Roche Reagent for CreatinineSummary page 1…bstantial Equivalence: The Creatinine assay is substantially equivalent to the following devices: « Roche® Cobas Mira®Plus Automated Chemistry System Creatinine assay (K941837) for the serum application Creatinine 510(k) Section II April 3, 1998 Page 1 0030013 « Boehringer Mannheim® Cr… | 1994 |
| * | K812095 | Enxymatic Creatinine TestSummary page 2…the serum application Creatinine 510(k) Section II April 3, 1998 Page 1 0030013 « Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer (K812095) for the urine application These assays yield similar Performance Charactenstics. Similarities to Roche: « Both assays are in… | 1981 |
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?
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K941837.
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?
The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981240 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981240: Creatinine (Crea).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981240
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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