Cleared Traditional

K161527 - Teco Creatinine Enzymatic Reagent Kit

K161527 is an FDA 510(k) clearance for Teco Creatinine Enzymatic Reagent Kit, 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 414-day FDA review.

K161527 · Teco Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
414d
Days
Class 2
Risk

K161527 is an FDA 510(k) clearance for the Teco Creatinine Enzymatic Reagent Kit. 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 July 21, 2017 after a review of 414 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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.

FDA 510(k) Submission Details - K161527

510(k) Number K161527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2016
Decision Date July 21, 2017
Days to Decision 414 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
326d slower than avg
Panel avg: 88d · This submission: 414d
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 48
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K161527 · Teco Creatinine Enzymatic Reagent Kit
Download PDF FDA Summary Teco Diagnostics, Inc.