Cleared Traditional

K251800 - Healgen® URS Test Strips (FDA 510(k) Clearance)

Class I Chemistry device.

K251800 · Healgen Scientific, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
194d
Days
Class 1
Risk

K251800 is an FDA 510(k) clearance for the Healgen® URS Test Strips. Classified as Diazo (colorimetric), Nitrite (urinary, Non-quant) (product code JMT), Class I - General Controls.

Submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on December 23, 2025 after a review of 194 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1510 - 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.

View all Healgen Scientific, LLC devices

Submission Details

510(k) Number K251800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2025
Decision Date December 23, 2025
Days to Decision 194 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
106d slower than avg
Panel avg: 88d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JMT Diazo (colorimetric), Nitrite (urinary, Non-quant)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1510
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

LSI International, Inc.
Jenny Xia

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.