510(k) · Cleared
ClearedTru Kidney Health Test Panel; Tru Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truvian Health · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Nov 26, 2025 as substantially equivalent to K242685 (Siemens Healthcare Diagnostics, Inc., 2024) and 1 other predicate after a 236-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Nov 26, 2025
- Review
- 236 days
- Class
- Class II
- Product code
- CGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K973993 (1998). 9 ancestors in all, the oldest K942782 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK973993 Randox CreatinineRandox Laboratories, Ltd. · 1998
- 3 generations backK070727 Advia Chemistry Enzymatic Creatinine_2Siemens Medical Solutions Diagnostics · 2007 · Recalled
- 2 generations backK161494 Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
- 1 generation backK242685 Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. · 2024
- This deviceK251058 Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973993 | Randox Creatinine | Randox Laboratories, Ltd. | 1998 | — |
| −3 | K070727 | Advia Chemistry Enzymatic Creatinine_2 | Siemens Medical Solutions Diagnostics | 2007 | 5 |
| −2 | K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | Siemens Healthcare Diagnostics, Inc. | 2016 | 1 |
| −1 | K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
| 0 (this device) | K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K242685 | Atellica® CH Creatinine_3 (Crea3)Summary page 5…510(k) Exempt* * Meets limitations of exemption per 21 CFR § 862.9 (c)(9) 3 Predicate Devices Primary Predicate Device: Atellica CH Creatinine_3 (Crea3) (K242685) Additional Predicate Devices: Skyla Comprehensive Metabolic Panel (K171971) Skyla Clin… | 2024 |
| * | K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical…Summary page 5…Predicate Devices Primary Predicate Device: Atellica CH Creatinine_3 (Crea3) (K242685) Additional Predicate Devices: Skyla Comprehensive Metabolic Panel (K171971) Skyla Clinical Chemistry Analyzer (K171971)… | 2018 |
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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
- 6 of the 9 ancestors have a recall of any class.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Tru Kidney Health Test Panel is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Kidney Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Creatinine (CRE) and Blood Urea Nitrogen (BUN) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. From the CRE determination, Estimated…
Read the full statement (194 words)
The Tru Kidney Health Test Panel is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Kidney Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Creatinine (CRE) and Blood Urea Nitrogen (BUN) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. From the CRE determination, Estimated Glomerular Filtration Rate (eGFR) is calculated by the analyzer.
The Tru Kidney Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in diagnosing the following disorders in adults 18 years of age or older:
Creatinine (CRE): Renal disease and monitoring of renal dialysis.
Blood Urea Nitrogen (BUN): Certain renal and metabolic diseases.
The Tru Analyzer is an automated, multi-assay integrated system, containing an absorbance reader, a bead scanner, and a cell imager for in vitro diagnostic use. This analyzer is intended for the quantitative determination of various analyte concentrations found in lithium-heparinized venous whole blood. It is for clinical laboratory or point-of-care use.
Use only TruWellness Panel™ test kits with the Tru Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251058 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251058: Tru Kidney Health Test Panel; Tru Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251058
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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