Cleared Traditional

URITEST - NITRITE IN URINE TEST (K954685) - FDA 510(k) Clearance

Class I Chemistry device.

K954685 · Tcpi, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
285d
Days
Class 1
Risk

K954685 is an FDA 510(k) clearance for the URITEST - NITRITE IN URINE TEST. Classified as Diazo (colorimetric), Nitrite (urinary, Non-quant) (product code JMT), Class I - General Controls.

Submitted by Tcpi, Inc. (Beverly, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 285 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 Tcpi, Inc. devices

Submission Details

510(k) Number K954685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1995
Decision Date July 22, 1996
Days to Decision 285 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 88d · This submission: 285d
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.