Cleared Traditional

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (K152835) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152835 · Teco Diagnostics, Inc. · Chemistry device
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Mar 2016
Decision
160d
Days
Class 2
Risk

K152835 is an FDA 510(k) clearance for the URITEK TC-201 URINE CHEMISTRY TEST SYSTEM. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Teco Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on March 7, 2016 after a review of 160 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 Teco Diagnostics, Inc. devices

Submission Details

510(k) Number K152835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date March 07, 2016
Days to Decision 160 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
72d slower than avg
Panel avg: 88d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFY Enzymatic Method, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JFY Enzymatic Method, Creatinine

All 25
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K090330 · Siemens Healthcare Diagnostics, Inc. · May 2009