510(k) · Cleared
ClearedAtellica® CH Creatinine_3 (Crea3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Dec 4, 2024 as substantially equivalent to K161494 (Siemens Healthcare Diagnostics, Inc., 2016) after an 89-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Dec 4, 2024
- Review
- 89 days
- Class
- Class II
- Product code
- CGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973993 (1998). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK973993 Randox CreatinineRandox Laboratories, Ltd. · 1998
- 2 generations backK070727 Advia Chemistry Enzymatic Creatinine_2Siemens Medical Solutions Diagnostics · 2007 · Recalled
- 1 generation backK161494 Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
- This deviceK242685 Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK251058 Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025
Most influential descendants
Showing 1 of 1 · See all- K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973993 | Randox Creatinine | Randox Laboratories, Ltd. | 1998 | — |
| −2 | K070727 | Advia Chemistry Enzymatic Creatinine_2 | Siemens Medical Solutions Diagnostics | 2007 | 5 |
| −1 | K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | Siemens Healthcare Diagnostics, Inc. | 2016 | 1 |
| 0 (this device) | K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
| +1 | K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 K221813 Nova Allegro UACR Assay, Nova Allegro Analyzerscore 11.7 · 2 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 |
|---|---|---|---|
| * | K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Summary page 5…ate Device Predicate Device Predicate 510(k) Clearance# Atellica® CH Creatinine_3 Atellica® CH Creatinine_2 K161494 (Crea3) (Crea_2) Siemens Healthcare Diagnostics Inc.… | 2016 |
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 |
|---|---|---|---|
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer | 2025 | 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 26 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K251058 (Truvian Health, 2025) 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. 2024, 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?
The Atellica® CH Creatinine_3 (Crea3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin, dipotassium EDTA, and sodium heparin), and urine using the Atellica® CH Analyzer. Such 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/K242685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242685: Atellica® CH Creatinine_3 (Crea3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242685
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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