Cleared Traditional

IND URINARY TRACT INFECTION (UTI) TEST STRIPS (K103037) - FDA 510(k) Clearance

Class I Chemistry device.

K103037 · Ind Diagnostic, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
551d
Days
Class 1
Risk

K103037 is an FDA 510(k) clearance for the IND URINARY TRACT INFECTION (UTI) TEST STRIPS. Classified as Test, Nitrite, Urinary, Non-quantitative, Over The Counter (product code NGJ), Class I - General Controls.

Submitted by Ind Diagnostic, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on April 17, 2012 after a review of 551 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Ind Diagnostic, Inc. devices

Submission Details

510(k) Number K103037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2010
Decision Date April 17, 2012
Days to Decision 551 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
463d slower than avg
Panel avg: 88d · This submission: 551d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NGJ Test, Nitrite, Urinary, Non-quantitative, Over The Counter
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.