Cleared Traditional

K242767 - Safecare Urinary Tract Infection Test

K242767 is an FDA 510(k) clearance for Safecare Urinary Tract Infection Test, manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. The device is a Class 1 Chemistry device with product code JMT cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K242767 · Safecare Biotech (Hangzhou) Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
119d
Days
Class 1
Risk

K242767 is an FDA 510(k) clearance for the Safecare Urinary Tract Infection Test. Classified as Diazo (colorimetric), Nitrite (urinary, Non-quant) (product code JMT), Class I - General Controls.

Submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 10, 2025 after a review of 119 days - within the typical 510(k) review window.

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 Safecare Biotech (Hangzhou) Co., Ltd. devices

FDA 510(k) Submission Details - K242767

510(k) Number K242767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2024
Decision Date January 10, 2025
Days to Decision 119 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
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

JMT Device Classification - Class 1, General Controls

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 Peers - JMT Diazo (colorimetric), Nitrite (urinary, Non-quant)

Devices cleared under the same product code (JMT) and FDA review panel - the closest regulatory comparables to K242767.
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