Cleared Traditional

K252607 - AllTest Urinary Tract Infection Test (FDA 510(k) Clearance)

Class I Chemistry device.

K252607 · Hangzhou AllTest Biotech Co., Ltd. · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 2025
Decision
73d
Days
Class 1
Risk

K252607 is an FDA 510(k) clearance for the AllTest Urinary Tract Infection Test. Classified as Diazo (colorimetric), Nitrite (urinary, Non-quant) (product code JMT), Class I - General Controls.

Submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 30, 2025 after a review of 73 days - a notably fast clearance 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: 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 Hangzhou AllTest Biotech Co., Ltd. devices

Submission Details

510(k) Number K252607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2025
Decision Date October 30, 2025
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
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.