Cleared Traditional

K060120 - TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM

K060120 is an FDA 510(k) clearance for TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM, manufactured by Teco Diagnostics. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K060120 · Teco Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
69d
Days
Class 2
Risk

K060120 is an FDA 510(k) clearance for the TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on March 27, 2006 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teco Diagnostics devices

FDA 510(k) Submission Details - K060120

510(k) Number K060120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2006
Decision Date March 27, 2006
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDQ Device Classification - Class 2, Special Controls

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 101
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K060120.
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