Cleared Traditional

K052724 - TECO ISE REAGENT SET FOR CX SYSTEM

K052724 is an FDA 510(k) clearance for TECO ISE REAGENT SET FOR CX SYSTEM, manufactured by Teco Diagnostics. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K052724 · Teco Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
76d
Days
Class 2
Risk

K052724 is an FDA 510(k) clearance for the TECO ISE REAGENT SET FOR CX SYSTEM. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on December 14, 2005 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 - K052724

510(k) Number K052724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date December 14, 2005
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGS Device Classification - Class 2, Special Controls

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 141
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K052724.
PROLYTE ELECTROLYTE ANALYZER
K070104 · Diamond Diagnostics, Inc. · May 2008
EPOC BLOOD ANALYSIS SYSTEM
K061597 · Epocal, Inc. · Sep 2006
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
K053110 · I-Stat Corporation · Jan 2006
ISE INDIRECT NA, K, CL FOR GEN.2
K053165 · Roche Diagnostics Corp. · Dec 2005
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
K051646 · Pointe Scientific, Inc., · Oct 2005
GENCHEM ELECTROLYTE BUFFER
K040977 · Genchem, Inc. · Dec 2004