Cleared Traditional

K251074 - Tru Liver Health Test Panel (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251074 · Truvian Health · Chemistry device
Download Printable Device Report (PDF)
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Dec 2025
Decision
255d
Days
Class 2
Risk

K251074 is an FDA 510(k) clearance for the Tru Liver Health Test Panel. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Truvian Health (San Diego, US). The FDA issued a Cleared decision on December 19, 2025 after a review of 255 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K251074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2025
Decision Date December 19, 2025
Days to Decision 255 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 88d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Consultant

Truvian Sciences, Inc.
Tho Tran

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.