Cleared Traditional

K231045 - Healgen URS Test Strips (FDA 510(k) Clearance)

Class I Chemistry device.

K231045 · Healgen Scientific, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
65d
Days
Class 1
Risk

K231045 is an FDA 510(k) clearance for the Healgen URS Test Strips. Classified as Test, Urine Leukocyte (product code LJX), Class I - General Controls.

Submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on June 16, 2023 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7675 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Healgen Scientific, LLC devices

Submission Details

510(k) Number K231045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2023
Decision Date June 16, 2023
Days to Decision 65 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
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJX Test, Urine Leukocyte
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.7675
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.
Joe Shia

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.