Cleared Traditional

K251281 - Nova Max Creat eGFR Monitoring System (FDA 510(k) Clearance)

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

K251281 · Nova Biomedical Corporation · Chemistry device
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Optimized for regulatory review, auditing and printing
Jan 2026
Decision
272d
Days
Class 2
Risk

K251281 is an FDA 510(k) clearance for the Nova Max Creat eGFR Monitoring System. Classified as Creatinine Test System For At Home Prescription Use (product code SHB), Class II - Special Controls.

Submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on January 21, 2026 after a review of 272 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 K251281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2025
Decision Date January 21, 2026
Days to Decision 272 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
184d slower than avg
Panel avg: 88d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SHB Creatinine Test System For At Home Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
Definition For The Quantitative Measurement Of Creatinine In Home Use Settings By Patients As An Aid To Monitor Kidney Function. This Device Is For Prescription Use Only.
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.