Cleared Traditional

K152835 - URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

K152835 is an FDA 510(k) clearance for URITEK TC-201 URINE CHEMISTRY TEST SYSTEM, manufactured by Teco Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K152835 · Teco Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K152835

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.

JFY Device Classification - Class 2, Special Controls

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 35
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