Cleared Special

K053110 - 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 is an FDA 510(k) clearance for Abbott i-STAT Crea Cartridge, manufactured by I-Stat Corporation. The device is a Class 2 Chemistry device with product code JGS cleared through the Special 510(k) pathway after a 70-day FDA review.

K053110 · I-Stat Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
70d
Days
Class 2
Risk

K053110 is an FDA 510(k) clearance for the Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Car.... Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by I-Stat Corporation (East Windsor, US). The FDA issued a Cleared decision on January 13, 2006 after a review of 70 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all I-Stat Corporation devices

FDA 510(k) Submission Details - K053110

510(k) Number K053110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2005
Decision Date January 13, 2006
Days to Decision 70 days
Submission Type Special
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
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 135
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K053110.
VITROS CHEMISTRY PRODUCT NA+ SLIDES
K081411 · Ortho-Clinical Diagnostics, Inc. · Jun 2008
PROLYTE ELECTROLYTE ANALYZER
K070104 · Diamond Diagnostics, Inc. · May 2008
EPOC BLOOD ANALYSIS SYSTEM
K061597 · Epocal, Inc. · Sep 2006
TECO ISE REAGENT SET FOR CX SYSTEM
K052724 · Teco Diagnostics · Dec 2005
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