510(k) · Cleared
ClearedTru Liver Health Test Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truvian Health · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Dec 19, 2025 as substantially equivalent to K171971 (Lite-On Technology Corp. H.S.P.B., 2018) after a 255-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Dec 19, 2025
- Review
- 255 days
- Class
- Class II
- Product code
- CJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942782 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942782 | Piccolo (TM) | Abaxis, Inc. | 1995 | 1 |
| −1 | K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare… | Lite-On Technology Corp. H.S.P.B. | 2018 | — |
| 0 (this device) | K251074 | Tru Liver Health Test Panel | Truvian Health | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 CJE? 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 CJE device
- #1 K240468 Alkaline Phosphatasescore 8.8 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical…Summary page 5…510(k) Exempt* * Meets limitations of exemption per 21 CFR § 862.9 (c)(9) 3 Predicate Devices Primary Predicate Devices: Skyla Comprehensive Metabolic Panel (K171971) 4 Device Description The TruSystem is an automated, integrated in vitro diagnostic platform consisting of the Tru Analyzer a… | 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 30 years and passes through 3 companies; a new generation was cleared every 22.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K171971.
How does its category compare?
All CJE devicesCJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · CJE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJE
Too few CJE 510(k)s in any year since 2007 to give a median.
Recalls per year · CJE
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJE
10in 2025
MAUDE reports naming product code CJE, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 8 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 2 | — | 1 | 24 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Tru Liver Health Test Panel is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Liver Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care…
Read the full statement (136 words)
The Tru Liver Health Test Panel is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Liver Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings.
The Tru Liver 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:
Alkaline Phosphatase (ALP): Liver, bone, parathyroid, and intestinal diseases.
Aspartate Aminotransferase (AST): Certain types of liver and heart diseases.
Alanine Aminotransferase (ALT): Certain liver (e.g., viral hepatitis and cirrhosis) and heart diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251074: Tru Liver Health Test Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251074
Report an extraction error
Are you the manufacturer?
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