Tru Liver Health Test Panel
FDA 510(k) K251074 · Truvian Health
510(k) numberK251074
Submission
- Device name
- Tru Liver Health Test Panel
- Applicant
- Truvian Health
San Diego, CA, US - Received
- April 8, 2025
- Decision date
- December 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJE
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|---|---|---|---|
| K240468 | Alkaline PhosphataseCJE · Special | Abbott Laboratories Diagnostics Division | 10/16/2024SE |
| K223317 | Alkaline Phosphatase2CJE · Traditional | Abbott Ireland Diagnostics Division | 07/21/2023SE |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 AlbuminCJE · Traditional | Horiba Abx SAS | 08/30/2019SE |
| K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical…CJE · Traditional | Lite-On Technology Corp. H.S.P.B. | 01/25/2018SE |
| K171080 | ALP IFCC Gen.2CJE · Special | Roche Diagnostics Operations (Rdo) | 05/10/2017SE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | Randox Laboratories Limited | 04/21/2017SE |
| K131351 | Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentCJE · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 08/15/2013SE |
| K130141 | S Test Reagent Cartridge Alp (Alkaline Phosphatase)CJE · Traditional | Hitachi Chemical Diagnostics, Inc. | 03/22/2013SE |
| K113436 | Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L ReagentCJE · Traditional | Alfa Wassermann | 07/12/2012SE |
| K113269 | Elittech Clinical Systems Alp Ifcc SLCJE · Traditional | Elitechgroup | 12/29/2011SE |
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Questions and answers
When was Tru Liver Health Test Panel cleared by the FDA?
Tru Liver Health Test Panel (K251074) received a 510(k) decision of Substantially Equivalent on December 19, 2025, 255 days after the submission was received.
What is the product code of K251074?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.