510(k) · Cleared
Recalled · Class II · 2020Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
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 Nov 15, 2016 as substantially equivalent to K070727 (Siemens Medical Solutions Diagnostics, 2007) and 1 other predicate after a 167-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 15, 2016
- Review
- 167 days
- Class
- Class II
- Product code
- CGX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973993 (1998). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK973993 Randox CreatinineRandox Laboratories, Ltd. · 1998
- 1 generation backK070727 Advia Chemistry Enzymatic Creatinine_2Siemens Medical Solutions Diagnostics · 2007 · Recalled
- This deviceK161494 Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator…Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK242685 Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK251058 Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025
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 |
|---|---|---|---|---|---|
| −2 | K973993 | Randox Creatinine | Randox Laboratories, Ltd. | 1998 | — |
| −1 | K070727 | Advia Chemistry Enzymatic Creatinine_2 | Siemens Medical Solutions Diagnostics | 2007 | 5 |
| 0 (this device) | K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +1 | K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K070727 | Advia Chemistry Enzymatic Creatinine_2Summary page 5…ADVIA Chemistry Calibrator 510(k) Summary Page 1 of 10 Creatinine_2 (ECRE_2) (k050374) (k070727) DEVICE DESCRIPTION ATELLICA CH CREATININE_2 (CREA_2) The A… | 2007 |
| * | K050374 | Advia Ims Lithium AssaySummary page 5…DVIA Chemistry Enzymatic ADVIA Chemistry Calibrator 510(k) Summary Page 1 of 10 Creatinine_2 (ECRE_2) (k050374) (k070727) DEVICE DESCRIPTION ATELL… | 2005 |
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 |
|---|---|---|---|
| K242685 | Atellica® CH Creatinine_3 (Crea3) | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2020 | Class II | Z-2431-2020 | Nonconforming Material/Component | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K242685 (Siemens Healthcare Diagnostics, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K070727.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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_2 (Crea_2) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium 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.
The Atellica™ CH Chemistry Calibrator (CHEM CAL) is for in vitro diagnostic use in calibrating the Crea_2 assay using the Atellica™ CH Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161494: Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161494
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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